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Beckman Coulter’s Access PCT Procalcitonin Assay receives U.S. FDA 510(k) clearance

28 January 2020 - The Access PCT strengthens industry’s most extensive portfolio of in-vitro diagnostic testing for sepsis identification and management

Philips once again ranked among the world’s top global companies for its commitment to action on climate change

20 January 2020 - Philips on CDP Climate Change A-list for seventh year running. Philips recognized for its actions to reduce emissions, mitigate climate risks and develop the low-carbon economy.

Ortho’s Matthew Dawson in PM360: ‘Biggest Challenges for Marketers and How to Surmount Them’

16 January 2020 - What are the biggest challenges for marketers in 2020? Matthew Dawson, our director of global marketing for transfusion medicine, tells PM360 magazine that it’s better alignment between sales and marketing.

Hitado GmbH becomes Nexus IB10 distributor for sphingotec in Germany and Switzerland

14 January 2020

Biogen to acquire novel clinical stage asset with applicaton in Alzheimer’s disease and Parkinon's disease from Pfizer Inc.

13 January 2020 - PF-05251749 is a CNS-penetrant regulator of circadian rhythm with potential to address behavioral and neurological symptoms across various psychiatric and neurological diseases. Biogen to pay Pfizer $75 million upfront plus potential milestones of up to $635 million, and royalties. PF-05251749 complements the Company’s pipeline of potential disease-modifying therapies for Alzheimer’s and Parkinson’s diseases.

PerkinElmer Provides Newborn Screening Solution for Duchenne Muscular Dystrophy as part of PPMD’s New York State Pilot Program

13 January 2020 - First Infant Recently Screened for Most Prevalent Type of Muscular Dystrophies

bioMérieux submits enhanced BIOFIRE® BCID2 Panel for FDA clearance

13 January 2020

Beckman Coulter announces installation of DxH 900 and Early Sepsis Indicator at award-winning NHS pathology partnership

7 January 2020

Bio-Rad Appoints Dara Grantham Wright Executive Vice President and Clinical Diagnostics Group President

6 January 2020

QIAGEN concludes strategic alternatives review; decides to focus on stand-alone business strategy to drive future value creation

24 December 2019

Merck Licenses Foundational CRISPR Integration Technology to Promega

19 December 2019 -. Gives scientists a new view into natural cell activity, accelerating drug development

bioMérieux and the Fleming Fund: working together to strengthen diagnostic capacity and tackle antimicrobial resistance in low- and middle-income countries

18 December 2019

PerkinElmer Launches First FDA-Approved Assay Kit to Screen for Duchenne Muscular Dystrophy in Newborns

13 December 2019 - Available on PerkinElmer’s automated GSP® instrument, kit supports early diagnosis by measuring CK-MM concentration instead of CK enzyme activity

Roche receives CE Mark for its Accu-Chek SugarView app

10 December 2019 - Accu-Chek SugarView is the first app that determines blood glucose ranges by taking photos with the smartphone camera without the need of a blood glucose meter. It is designed to help non-insulin-dependent people with type 2 diabetes or pre-diabetes live healthier lives in-between doctors’ visits. Type 2 diabetes is the most common form of diabetes, accounting for around 90 % of all diabetes cases.

Changes in the Board of Directors and the Corporate Executive Committee of Roche

9 December 2019

Vela Diagnostics’ Next Generation Sequencing HIV Genotyping Assay receives approval from Singapore Health Sciences Authority

9 December 2019

Quest Diagnostics Acquires the Clinical Laboratory Services of Boston Clinical Laboratories in Massachusetts

2 December 2019

Sysmex Presents Academic Report with a View to Creating a Simple Method of Diagnosing Alzheimer’s Disease Using Blood

2 December 2019 - Presenting the Most Recent Data at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) Conference

QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Gold Plus Test on LIAISON platforms and begin commercial launch

27 November 2019 - Enabling highly automated screening solution for latent tuberculosis in all throughput segments

Japan and Singapore Grant CRISPR Patents to Merck

26 November 2019 - Merck now holds 22 CRISPR-related patents worldwide across nine different geographies. Patents cover Paired Cas9 Nickase CRISPR genome-editing technology to advance gene therapy and research.

Newly Published Research Shows that Hologic’s Molecular Assays for Diagnosing Vaginitis are More Effective than Traditional Methods

25 November 2019 - More sensitive and specific assays for vaginitis reduce the “incorrect, misguided or prolonged treatment” that can result from older, subjective testing methods

Cinven and Astorg to acquire LGC

Philips employees and Philips Foundation join forces in the fight on childhood pneumonia

14 November 2019 - Focused program of partnerships, collaboration, funding and volunteering addresses the community-level prevention, diagnosis and treatment of a disease that takes the lives of around 800,000 under-five-year-olds each year, mostly in disadvantaged communities.

HDL Cholesterol Function Lab Test Offers Novel Insight into Cardiovascular Disease Risk, Reports Quest Diagnostics at American Heart Association 2019 Scientific Sessions

14 November 2019 - Other Company Research Demonstrates the Value of Diagnostic Insights in Early Cardiovascular Disease Detection in Clinical and Workplace Settings

Danaher announces appointment of Jessica L. Mega, MD, MPH and Pardis C. Sabeti, MD, D.Phil to Dahaher Board

13 November 2019

Grifols and Shanghai RAAS obtain authorization for their strategic alliance in China

13 November 2019 - The operation is expected to close before the end of 2019, after the necessary approvals have been received from the regulatory authorities in the United States and the People’s Republic of China. Grifols will control a 26.2% stake in Shanghai RAAS (economic and voting rights) in exchange for a non-majority share (45% economics rights and 40% voting rights) in Grifols Diagnostic Solutions (GDS), a wholly owned Grifols subsidiary. This transaction is the first share swap made in China with shares of a foreign company (GDS) and a non-state-controlled Chinese listed company. This alliance is an important step forward in Grifols’ long-term vision and sustainable growth strategy, generating value for all of its divisions, especially the Bioscience and Diagnostic Divisions, as a driver of plasma-derived and diagnostic products in the Chinese market.

New breakthrough in Lyme Disease testing reduces time to results from days to minutes

12 November 2019 - Revolutionary Lyme Test to be rolled out at select urgent care and physician offices nationwide

BD Submits Pre-Market Approval Supplement to FDA for BD Onclarity™ HPV Test with Extended Genotyping Capabilities

12 November 2019

Newly Published Research Demonstrates Ability of Hologic’s Assay to Detect Mycoplasma Genitalium, “the Silent Epidemic”

11 November 2019 - First FDA-cleared test for this sexually transmitted bacterium can lead to earlier detection and appropriate treatment

Grifols introduces AlphaID™, a free cheek swab to screen for Alpha-1, the most common genetic form of COPD

7 November 2019 - 90% of individuals remain undiagnosed with severe Alpha-1, even though a simple screening test will quickly detect the condition. AlphaID™ makes it simple for physicians to quickly rule out Alpha-1, the number one known genetic risk factor for chronic obstructive pulmonary disease (COPD). November is National COPD Awareness Month

Abbott announces discovery of new strain of HIV, keeping global health community a step ahead of the virus

6 November 2019 - Discovery marks the first time a new subtype of HIV-1 has been identified since 2000. Abbott is making this new strain accessible to the research community to evaluate its impact to diagnostic testing, treatments and potential vaccines.

QIAGEN’s QuantiFERON®-TB Gold Plus test added to the Global Drug Facility catalog for public health efforts

29 October 2019 - QIAGEN expands market for gold standard latent TB test to help developing countries fight TB. WHO-endorsed test to support communities with the highest need. First demonstration of QuantiFERON®-TB Access at the Union World meeting in India

BD and Check-Points Receive FDA Clearance for Molecular Screening Test to Detect Antibiotic-Resistant Bacteria

29 October 2019

Edan Diagnostics acquires molecular diagnostic point of care platform from LGC

28 October 2019 - Edan Diagnostics, Inc., a wholly own subsidiary of Edan Instruments, Inc., a world leader in the development and manufacture of bio-electronic devices and laboratory analyzers for medical diagnostics, and LGC, a global life science tools leader, announced today the sale of LGC’s ClariLight molecular diagnostics Point of Care (POC) platform to Edan

RAPIDPoint 500e Blood Gas System from Siemens Healthineers featuring Integri-sense Technology: Delivering Confidence with Every Patient Result

22 October 2019 - The RAPIDPoint® 500e Blood Gas System from Siemens Healthineers incorporates Integri-sense™ Technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. Integri-sense Technology combines three levels of automatic quality control (AutomaticQC), multiple calibration routines and advanced software algorithms to generate reliable and clinically actionable test results, allowing clinicians to focus on patient care.

HealthEC, LabCorp, and The New Jersey Primary Care Association Announce Strategic Collaboration to Advance Value-Based Care at Community Health Centers

21 October 2019 - Agreement Establishes Database and Information Exchange Platform to Facilitate Care-Delivery Collaboration Between Participating New Jersey FQHCs Through LabCorp’s Care Intelligence Module

Mid-size laboratories can now enjoy the same efficiency benefits as large facilities with Beckman Coulter’s new hematology analyzer

21 October 2019 - Designed for mid-volume laboratories, Beckman Coulter’s DxH 690T offers industry-leading 93% first pass yield, and includes a 5-part differential and the Early Sepsis Indicator

The Australian Red Cross Blood Service selects Abbott's Alinity s solution for blood and plasma screening

21 October 2019 - Abbott and the Australian Red Cross Blood Service extend 30-year partnership of providing safe, life-saving blood supply in Australia

Thermo Fisher Scientific Launches New External Molecular Control Panel for the Analytical Evaluation of BCR-ABL Test Methods

17 October 2019

Abbott and Tandem Diabetes Care exploring new integrated solutions to improve diabetes management

15 October 2019 - Companies aim to integrate Abbott's FreeStyle Libre glucose sensing technology with Tandem's insulin delivery products to expand choices for people with diabetes

PerkinElmer Launches PG-Seq™ Rapid Non-Invasive Preimplantation Genetic Testing Kit as Alternative to IVF Embryo Biopsies

14 October 2019 - New kit shown to achieve over 90% correlation rate between biopsied embryos and testing spent culture media

Instrumentation Laboratory awarded 2019 IMV ServiceTrak Award for Best Hemostasis System Performance

8 October 2019

Illumina and QIAGEN Partner to Deliver Sequencing-Based In-Vitro Diagnostic (IVD) Tests

7 October 2019 - Partnership to accelerate the adoption of next-generation sequencing (NGS) in clinical decision-making

QIAGEN announces CEO leadership transition

7 October 2019 - Peer M. Schatz to step down as CEO to pursue new opportunities. Remains as Special Advisor to facilitate a smooth transition. Search started for permanent CEO to lead QIAGEN in next growth phase. Thierry Bernard to act as interim CEO, working in tandem with CFO Roland Sackers.

Cepheid Receives FDA Clearance for Xpert® BCR-ABL Ultra Test

2 October 2019 - Enabling on-demand monitoring of BCR-ABL levels in patients with Chronic Myeloid Leukemia (CML)

Luminex Receives FDA 510(k) Clearance for the ARIES® MRSA Assay PDF Version

1 October 2019

U.S. FDA clears Abbott's High Sensivity Troponin-I blood test that aids doctors in diagnosing heart attacks faster and more accurately

25 September 2019 - Newly cleared diagnostic test could help identify heart attacks several hours sooner than standard troponin tests and help improve diagnosis in women

FDA approves cobas Babesia, Roche’s first whole blood test for donor screening

20 September 2019 - Roche is dedicated to helping save patients’ lives by delivering state-of-the-art solutions to aid in the protection of the global blood supply from infectious diseases. If undetected, Babesia infection can be fatal in patients receiving blood transfusions from infected donors. The availability of the new whole blood collection tube simplifies Babesia sample preparation, enabling more efficient laboratory processing and future menu expansion.

Community Clinics Receive Grant for Point-of-Care Diagnostics

19 September 2019 - BD, Heart to Heart International and the NAFC Announce 2019 Grantees for Multi-Year Diagnostic Testing Initiative to Improve Patient Outcomes

The Only Automated, On-Demand Test to Aid in the Diagnosis and Monitoring of Thrombotic Thrombocytopenic Purpura

19 September 2019

Quest Diagnostics and hc1 Collaborate to Optimize Enterprise-wide Laboratory Testing for Health Systems

12 September 2019 - Strategic collaboration aims to improve patient care and reduce costs across thousands of health systems nationwide by delivering insights that empower optimal lab testing

Thermo Fisher Scientific Signs Agreement with Lilly Oncology for Companion Diagnostic to be Used with RET Inhibitor

9 September 2019 - Strategic agreement utilizes FDA-approved next-generation sequencing Oncomine Dx Target Test to identify RET-altered non-small cell lung cancer and thyroid cancer patients who may be suitable for LOXO-292, Lilly's RET inhibitor

Genedrive Prepping for UK Commercial Launch of PGx Test for Neonatal Hearing Loss

30 August 2019

Daniela Seabrook to succeed Ronald de Jong as Philips’ Chief Human Resources Officer

26 August 2019

New Study finds Abbott's Blood Test Technology could help detect brain injury quickly, even if CT Scan is normal

26 August 2019 - The TRACK-TBI study found that 64% of people with the highest levels of a protein in the blood were confirmed to have brain injury through an MRI scan, even when a CT scan did not detect it. Abbott's diagnostic test, currently in development, is poised to be the first point-of-care blood test for assessing concussions on its next generation i-STAT™ device, providing doctors results in 15 minutes.

Clinical Study Published in Prenatal Diagnosis Further Validates PerkinElmer’s Vanadis Fully Automated NIPT Platform

21 August 2019 - CE-Marked Solution Gives Pregnant Women Widespread Access to Non-Invasive Prenatal Testing

Instrumentation Laboratory presents new GEM Premier ChemSTAT™ testing system with iQM® at American Association for Clinical Chemistry Annual Meeting

14 August 2019 - System Also Featured in Continuing Education Workshop at Meeting

QIAGEN’s new QIAstat-Dx Gastrointestinal Panel demonstrates excellent performance in multicenter clinical study in Europe

14 August 2019 - High sensitivity and specificity, plus insights for quantifying infections and identifying co-infections

New Blood Tests Help Assess Asthma Risk and Decide Pet Selection

6 August 2019 - ImmunoCAP Allergen Components test for specific proteins that cause allergic sensitization to dogs, cats and horses

PerkinElmer Launches EUROIMMUN ELISA for Detection of Aspergillus Infections

5 August 2019 - New assay provides in vitro determination of galactomannoprotein in immunocompromised patients

Changes in the Managing Board of Siemens Healthineers

29 July 2019 - Christoph Zindel appointed to Managing Board of Siemens Healthineers AG. Michael Reitermann to leave the company in amicable agreement. Managing Board’s business responsibilities reorganized.

Mesa Biotech to Launch Molecular, Sample-to-Answer RSV Test at the 2019 AACC Annual Scientific Meeting

29 July 2019 - RSV Test Represents Expansion of FDA Cleared, CLIA-Waived and CE Marked

Delaware District Court Grants Bio-Rad’s Motion for Permanent Injunction Against 10X Genomics

24 July 2019

PerkinElmer and EverlyWell Announce Collaboration to Expand U.S. At-Home Health Test Market

24 July 2019 - Combines PerkinElmer’s expertise in immunodiagnostic testing and state-of-the-art genomics program with EverlyWell’s consumer health offerings

LabCorp Expands Consumer-Initiated Test Offering

22 July 2019 - Pixel by LabCorp Now Available with Phlebotomy Collection Through LabCorp’s Nationwide Patient Service Center Network

Roche expands the Global Access Program beyond HIV to also include diagnostic tests for Tuberculosis, Hepatitis, and Human Papillomavirus

22 July 2019 - Access to innovative diagnostic solutions will contribute to the World Health Organization’s infectious disease elimination goals. Improving access to reliable diagnostics for disease management in countries with the highest burden. Early detection of infectious diseases with diagnostics helps clinicians save lives.

Quest Diagnostics Welcomes New Members to the Global Diagnostics Network (GDN)

18 July 2019 - Two new companies join the GDN, expanding this novel worldwide network of leading diagnostics service providers. With nine members spanning the globe, the GDN has a presence in countries covering two-thirds of the world's population, and over 90% of the global pharmaceutical market.

Siemens Healthineers equips new central laboratory for München Klinik

16 July 2019 - München Klinik and Siemens Healthineers enter into eight-year innovation partnership to equip future central lab in Neuperlach and existing emergency labs at other hospital locations. Key component in upgrade: 29 Atellica Solution laboratory diagnostic systems from Siemens Healthineers. Patients will benefit from high-quality medical lab services.

Siemens Healthineers, the University of Missouri and its hospital system announce formation of new strategic alliance

12 July 2019 - University of Missouri System and Siemens Healthineers have entered into a commercial agreement valued at $133 million U.S. dollars. The partnership is designed to significantly improve health care in the region. Focus of the partnership is on precision health and digital healthcare solutions

Abbott announces FDA approval of the Alinity™ s System, the latest technology for screening and protecting the U.S. blood and plasma supply

11 July 2019 - Alinity™ s System will screen the U.S. blood and plasma supply faster and more efficiently while maintaining highest levels of accuracy

PerkinElmer Launches CE-Marked Infectious Disease Immunoassays on EUROIMMUN Random Access Instrument

10 July 2019 - ChLIA-based tests for detection of antibodies against Borrelia and Epstein-Barr Virus now available on EUROIMMUN RA Analyzer 10 System

Quest Diagnostics Launches New Consumer-Initiated Lyme Disease Tests Through QuestDirect™

9 July 2019 - Available Nationwide, New Service Connects Consumers with Medical-Grade Testing and Access to Physician Oversight, Counsel and Prescription Therapy When Appropriate

Luminex Submits ARIES MRSA Assay for FDA Clearance

1 July 2019

Illumina Files Patent Infringement Suits Related to BGI in Switzerland, Turkey and the US

28 June 2019

United States and Indonesia Expand Collaboration to End Tuberculosis

27 June 2019

Evaluation of the Clinical Performance of the Genedrive HCV ID Kit in Senegal

27 June 2019

BGI Genomics and Eluthia Launch Non-Invasive Prenatal Test in Germany, offering prenatal screening for 96 different genetic conditions

27 June 2019

QIAGEN and McKesson agree to distribute QIAstat-Dx syndromic testing solution to smaller hospitals and other select segments in the United States

19 June 2019 - Agreement adds commercial firepower for QIAGEN’s U.S. launch of the next generation platform for syndromic insights initially for respiratory conditions

Quidel Receives 510(k) Clearance for Quidel Triage® TOX Drug Screen, 94600 Toxicology Test for Use With Quidel’s Triage® MeterPro Instrumented System

19 June 2019

BD Unveils New Solution for High Throughput Molecular Diagnostic Testing

18 June 2019 - Automated BD COR™ System Achieves CE-IVD Status; Now Available in Europe

Abbott launches first-ever rapid point-of-care HbA1c test to aid in the diagnosis of diabetes

17 June 2019 - Afinion™ HbA1c Dx test provides results in three minutes, enabling clinicians to develop informed, individualized care plans during patient consultation. Assay is the first and only rapid point-of-care test cleared by the U.S. Food and Drug Administration (FDA) to aid healthcare professionals in the diagnosis of diabetes.

Illumina Wins Infringement Suit Against Ariosa Diagnostics, Inc.

17 June 2019

Changes in Roche's Board of Directors and Corporate Executive Committee

11 June 2019

New data show use of Abbott's Freestyle® Libre System significantly reduces HbA1c levels in people living with Type 2 Diabetes

8 June 2019 - Presented as a late-breaker at the American Diabetes Association (ADA) 79th Scientific Sessions, new real-world data demonstrate that monitoring glucose with FreeStyle Libre System has a positive impact among adults with Type 2 Diabetes who use multiple injections of insulin daily. Findings represent the first ever evaluation of real-world evidence specifically from the subset of people with Type 2 diabetes using Abbott's FreeStyle Libre system. Data underscore how actionable insights from the FreeStyle Libre system could help the more than 425 million people with diabetes globally make better decisions to improve diabetes management.

bioMérieux increases its holding in Hybiome from 54% to 67%

6 June 2019

QIAGEN and DiaSorin collaborate on novel QuantiFERON-based test with breakthrough potential for earlier detection of Lyme disease

5 June 2019 - Developing QuantiFERON-Lyme test for use on DiaSorin’s widely used LIAISON analyzers

World Anti-Doping Agency Coordinates Global Implementation of Sysmex Analyzers at All Blood Laboratories

4 June 2019 - Contributing to Clean and Fair Sports Management by Enhancing the Quality of Doping Tests

FDA Clearance of Aptima BV and Aptima CV/TV Molecular Assays Ushers in New Era of Comprehensive and Objective Diagnostic Testing for Vaginitis

29 May 2019 - Improved accuracy in identifying bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis, CV) and trichomoniasis (Trichomonas vaginalis, TV) will enable more targeted treatment for women

QIAGEN launches first FDA-approved companion diagnostic for PIK3CA biomarkers to enhance precision medicine in breast cancer

24 May 2019 - Innovative therascreen® PIK3CA RGQ PCR Kit receives U.S. regulatory approval for use in guiding treatment decisions from tissue and liquid biopsy for newly approved therapy PIQRAY® (alpelisib) from Novartis

QIAGEN’s QuantiFERON®-TB Access development program gains recognition from United Nations initiative for health innovation

21 May 2019 - New breakthrough test for low-resource, high-burden regions to help in global fight against tuberculosis

LGC announces VALIDATE® High Sensitive Troponin kit for easier linearity and calibration verification on Beckman Coulter DxI / Access® analyzers

21 May 2019

PROGEN with new joint leadership

15 May 2019 - Katja Betts and Maik Lander follow former General Manager Dr. Sven Kuhlendahl as new Managing Directors.

New Roche test aids clinicians in accelerating tuberculosis diagnosis and treatment by detecting antimicrobial resistance within the world’s leading cause of infectious disease deaths

14 May 2019 - New tests on cobas 6800/8800 systems provide clinicians information to help speed treatment and reduce the spread of infection. Rising challenge of drug resistance compounds the tuberculosis global health crisis. Mycobacteria test menu allows detection of tuberculosis, drug resistant tuberculosis and nontuberculous mycobacteria infections from single patient sample.

Siemens Healthineers Hemoglobin A1c Test for Diagnosing and Monitoring Diabetes Now Available on the Atellica Solution

14 May 2019 - Increased demand for diabetes testing is a challenge for clinical laboratories. The Atellica® CH Enzymatic Hemoglobin A1c (A1c_E) Assay is an easy-to-implement chemistry test, offering precise and accurate results for diabetic patient management. The A1c_E assay is less prone to testing interference and greatly improves HbA1c testing throughput compared to traditional HPLC assays.

NEPHROCHECK Biomarkers TIMP-2 and IGFBP7 Included in the ERAS “Guidelines for Perioperative Care in Cardiac Surgery”

13 May 2019

Abbott receives WHO prequalification approval for breakthrough HIV point-of-care test

2 May 2019 - WHO Prequalification approval allows Abbott to bring critical technology to more resource-limited settings. Confirms that the m-PIMA™ HIV-1/2 VL meets global standards of quality, safety and efficacy.

New Study Results Find That The Blood Biomarker MR-proADM May Prevent Early Hospital Discharge in Patients with Developing Sepsis

2 May 2019 - Multi-centre analysis shows that incorporation of MR-proADM (mid-regional proadrenomedullin) into an early management of patients with suspected infection protocol may aid rapid clinical decision making in the emergency department

Abbott, the U.S. Department of Defense and TRACK-TBI partner to study point-of-care blood test for concussions

30 April 2019 - Academic, military and healthcare leaders have come together to conduct a scientifically rigorous clinical trial of a blood test in development for the brain. Research could lead to the first point-of-care blood test of its kind to help evaluate concussions within minutes.

New studay finds Abbott blood test can help predict future cardiac events in adults with no known heart disease

29 April 2019 - Research found Abbott's High-Sensitive Troponin-I blood test may identify adults at risk of having a cardiac event, independent of other heart disease risk factors. Abbott's core laboratory diagnostic test is the first troponin blood test with CE Mark that can more accurately predict risk of developing heart disease, when added to other heart disease risk assessments, than using other assessments alone.

Sysmex Obtains CE Certification for Automated Hematology Analyzer XN-31, Which Has an Automatic Measurement Function for Red Blood Cells Infected by Malaria Parasites

25 April 2019 - Contributing to the Early Detection and Treatment of Malaria through Standardized and More Efficient Malaria Testing

LGC announces VALIDATE® LP kit for easier linearity and calibration verification on SIEMENS ADVIA® and ATELLICA® analyzers

24 April 2019

Quest Diagnostics Launches New Consumer-Initiated STD Tests Through QuestDirect™

18 April 2019 - Available nationwide, the new services link consumer-initiated testing with medical oversight and counsel to help combat the nation's record rate of STDs

Beckman Coulter’s Early Sepsis Indicator Receives 510(k) Clearance from the U.S. Food and Drug Administration

18 April 2019 - New hematologic biomarker has the potential to revolutionize clinicians’ approach to sepsis triage and diagnosis

Hologic Receives European CE Mark for ThinPrep® Genesis Processor, an Automated Cytology Slide and Molecular Sample System

18 April 2019 - New instrument offers workflow, automation, chain of custody and ergonomic benefits to clinical labs

Cepheid Announces FleXible Cartridge Program

15 April 2019 - SpeeDx is the First Trusted Reagent Manufacturer to launch a new test for use on the GeneXpert® System

QIAGEN’s QuantiFERON®-TB passes milestone of 60 million tests in global fight against tuberculosis, current annual run rate exceeds 12 million tests

11 April 2019 - New automation options highlighted for QuantiFERON®-TB Gold Plus at ECCMID 2019 to increase efficiency and improve ease of adoption for modern gold standard latent TB test

Thermo Fisher Scientific Launches New Immunoassay for Kratom Alkaloid Mitragynine Screening

10 April 2019

Mesa Biotech to Introduce Expanded Molecular POC Testing Portfolio at the European Congress of Clinical Microbiology and Infectious Diseases

9 April 2019 - Mesa Biotech to Introduce Expanded Molecular POC Testing Portfolio at the European Congress of Clinical Microbiology and Infectious Diseases

Beckman Coulter’s New Procalcitonin Assay Helps Physicians Accurately Identify Patients at Risk for Progression to Septic Shock

26 March 2019 - Access PCT strengthens industry’s most extensive portfolio of in-vitro diagnostic testing for sepsis identification and management

Vela Announces FDA Submission for HIV Genotyping and DRM Assay

26 March 2019 - Vela announces FDA submission for the Sentosa® SQ HIV Genotyping Assay, a NGS genotyping and DRM detection IVD test intended for use as an aid in monitoring and treating HIV-1 infection.

BD Launches New Automated Flow Cytometry Sample Preparation Instrument with CE-IVD Certification

26 March 2019 - BD FACSDuet™ system raises the bar on flow cytometry automation offering a fully integrated sample-to-answer solution with the BD FACSLyric™ clinical flow cytometer

Beckman Coulter’s Compact, Low-volume Hematology Analyzer Receives FDA 510(k) Clearance

21 March 2019 - With just 17 microliters of blood, the DxH 520 enables low-volume laboratories to deliver 5-part differential test results in 60 seconds or less

Baxter and bioMérieux announce collaboration to improve identification and treatment of acute kidney injury

19 March 2019

Abbott announces CE Mark for Alinity™ m diagnostics system and assays, the latest in molecular technology, to help deliver critical test results and benefits to patients

19 March 2019 - Alinity m will allow labs to meet the growing demand for infectious disease testing by offering increased efficiency and market-leading speed and accuracy. This new technology presents one of the most significant advancements seen in the molecular diagnostics field in decades.

New real-world evidence analysis of nearly half a million FreeStyle® Libre system users shows higher rates of scanning improves glucose control

21 February 2019 - Data presented at ATTD confirms previous analyses that higher rates of scanning with the FreeStyle Libre system are strongly associated with improved glucose control. Prolonged hypoglycemia reduced by up to 56 percent if users scan a second time within an hour of low glucose readings. Trend arrow readings before meals can help identify glucose levels that can potentially be used to adjust treatment and address after meal hyperglycemia.

Abbott and Novo Nordisk enter partnerhsip to provide integrated digital solution to people with diabetes using insulin

20 February 2019 - Collaboration will enable insulin data to be shared between Novo Nordisk connected insulin pens and digital health tools compatible(i) with FreeStyle Libre portfolio of products

Abbott introduces the world's most sensitive rapid diagnostic test, Determine™ HBsAg 2, to accelerate Hepatitis B Care

20 February 2019 - New point-of-care rapid test identifies and helps make effective care more accessible for millions of people living with hepatitis B, in support of World Health Organization (WHO) hepatitis targets. Life-changing test has obtained CE Mark and is now available in Europe, Africa, Asia, Latin America, and other countries that recognize CE Mark.

Hologic’s Aptima HIV-1 Quant Dx Assay Receives Two CE Marks, Making It the First and Only Dual-Claim Assay for Both Viral Load and Early Infant Diagnosis

14 February 2019

Grifols Receives FDA Approval for Procleix Babesia Assay for Donor Screening on Procleix Panther System

7 February 2019 - New assay enables blood banks to screen for the Babesia parasite in donated blood. Babesia transfusion-transmitted infections (TTIs) have been a major source of TTIs in the United States. Procleix Babesia assay provides U.S. blood banks the ability to screen whole blood donations for the presence of four clinically relevant species of the Babesia parasite and improve blood transfusion safety.

Illumina Names Susan E. Siegel to Its Board of Directors

6 February 2019 - Adding Decades of Leadership Experience in Personalized Medicine, Digital Health and Life Sciences

1,520 reference genomes from cultivated human gut bacteria enable functional microbiome analyses

5 February 2019 - Researchers from BGI-Shenzhen, the South China University of Technology, and elsewhere have isolated almost 6,500 bacterial representatives from fecal samples donated by 155 healthy individuals, using 11 types of growth media to culture the gut bacteria under anaerobic conditions in the lab.

New Hologic Assay is First and Only FDA-Cleared Diagnostic Test to Detect Emerging Health Threat Mycoplasma genitalium

23 January 2019 - FDA clearance makes clinically validated assay available for sexually-transmitted infection listed as emerging threat by the CDC.

New Blood Test Helps Clinicians Identify Potentially Life-threatening Ara h 6 Peanut Sensitization

22 January 2019 - ImmunoCAP Specific IgE blood test for Ara h 6 is part of the line of component assays from Thermo Fisher Scientific that can differentiate between individual peanut proteins with varying levels of risk

Japanese Red Cross Society selects Abbott Technology to screen Country's Blood and Plasma Supply

17 January 2019 - Long-term agreement between Japanese Red Cross Society and Abbott brings together two global leaders in blood and plasma screening, helping ensure a safe and efficient blood supply across Japan

QIAGEN receives approval for EGFR test in lung cancer as companion diagnostic in Japan

16 January 2019 - PMDA allows use of therascreen® EGFR RGQ PCR Kit for targeted treatment with Pfizer’s VIZIMPRO® (dacomitinib) in patients with non-small cell lung cancer

Abbott and

11 January 2019 - Abbott to supply rapid diagnostic tests critical for malaria detection and surveillance, technical expertise and funding support. Initiative focuses on Odisha, the state with the highest burden of malaria in India.

Grifols receives FDA approval of Erytra Eflexis®, the latest advancement in scalable blood typing solutions

8 January 2019 - Erytra Eflexis is a fully automated, benchtop analyzer that performs pretransfusion compatibility testing. This system incorporates two laboratory configurations in a single instrument, providing laboratory technicians adaptable solutions for daily workloads. Grifols is a leader in innovative blood typing systems that support safer transfusions worldwide.

Christine Tsingos Announces Plans to Retire as CFO of Bio-Rad Laboratories, Inc. Effective April 30, 2019

3 January 2019

GENFIT and LabCorp Sign a Licensing Agreement to Expand Access to an Innovative Diagnostic Assay for Non-Alcoholic Steatohepatitis (NASH)

3 January 2019 - Multi-Biomarker Test Will Provide the Clinical Research Community with a Non-Invasive Tool to Identify and Monitor Patients with NASH and Significant Fibrosis

Cepheid Receives CE-IVD Clearance for Xpert® HBV Viral Load

20 December 2018 - Simplify Hepatitis B Treatment Management

BD Completes Molecular Portfolio For GI Infection With New Viral Panel

20 December 2018 - BD MAX™ Enteric Viral Panel Receives 510(k) Clearance from U.S. Food and Drug Administration

Quidel Receives CE Mark for Its Point-of-Care Sofia® Quantitative Vitamin D Assay for Use With Sofia Instrument

19 December 2018

bioMérieux receives FDA clearance for BPA and BPN culture bottles used with BACT/ALERT® VIRTUO® for quality control testing of platelets

19 December 2018

Quidel Announces the Availability of Triage® PLGF Assay for Use with Quidel’s Triage® MeterPro Instrumented System

13 December 2018

Thermo Fisher Scientific Launches Complementary Diagnostic Immunoassay Measuring Plazomicin Concentrations

10 December 2018

With a View to New Value Creation, Sysmex Launches a Research Assay Service for HDL Function Measurement

4 December 2018 - Aiming to Prevent Atherosclerosis-Related Diseases and Provide Treatment Opportunities

Beckman Coulter Diagnostics Joins with Sepsis Alliance to Help Improve Sepsis Patient Outcomes

3 December 2018

Sysmex Launches Revohem FIX Chromogenic, a Blood Coagulation Factor IX Measurement Kit

3 December 2018 - Japan’s First Coagulation Factor IX Measurement Kit Using Chromogenic Assay, Helping to Diagnose and Assist in the Treatment of Hemophilia B

AbbVie sponsored REACH study for the use of Genedrive HCV assay in pharmacies

29 November 2018

Quidel Receives CE Mark for TriageTrueTM High Sensitivity Troponin I Test, Its Next-Generation Diagnostic Assay for Aid in Diagnosis of Myocardial Infarction for Use with Quidel’s Triage® MeterPro Ins

29 November 2018

FDA Approves Expanded Use for Ortho Clinical Diagnostics VITROS® HIV Combo Test

28 November 2018 - New Availability of the VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator to Help Labs Using Ortho’s VITROS® ECi/ECiQ Immunodiagnostic System to Diagnose HIV Infection

QIAGEN extends comprehensive offering for cervical cancer screening with European launch of QIAscreen HPV PCR Test

28 November 2018 - New addition to the QIAsymphony product family; an RGQ-based HPV test to support consolidated laboratory market segment

LGC acquires Seracare Life Sciences, strengthening its position in clinical quality control tools

26 November 2018

PerkinElmer Receives CE-IVD Mark for Its Vanadis Fully Automated NIPT Platform

26 November 2018 - Innovative Cost-Effective Solution Provides Pregnant WomenWidespread Access to Non-Invasive Prenatal Testing

CALiaGold – The new quantitative immunoassay from Sentinel Diagnostics for calprotectin measurement in SENTiFIT 270 Analyser

26 November 2018

Ludwig N. Hantson Elected to Hologic Board of Directors

19 November 2018

bioMérieux launches the BIOFIRE® FILMARRAY® Pneumonia Panels with FDA clearance and CE Marking

13 November 2018

Open Access™ Functionality Now Available on Hologic’s New Panther Fusion® System

8 November 2018 - New myAccess™ Software Allows Laboratory Developed Tests to Run Alongside Hologic’s Commercially Available IVD Assays

Quest Diagnostics, a Pioneer in Consumer Health, Expands Offering with Launch of QuestDirect, a Service that Provides Consumers Access to Lab Testing without Visiting a Doctor's Office

7 November 2018 - QuestDirect Builds on Quest's existing consumer offerings available through the new and improved MyQuest patient platform that lets people access their lab results, schedule appointments and pay bills

FDA Approves Ortho Clinical Diagnostics VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for Use on the VITROS® 5600 Integrated System

6 November 2018 - Expanded Use on the VITROS® 5600 Integrated System Will Help Labs Maximize Workflow Efficiencies

Illumina to Acquire Pacific Biosciences for Approximately $1.2 Billion, Broadening Access to Long-Read Sequencing and Accelerating Scientific Discovery

1 November 2018 - Brings Together Highly Accurate Short- and Long-Read Sequencing Technologies, Paving the Path to a More Perfect View of a Genome. Pacific Biosciences’ Recent Advances with its Sequel SMRT® Technology, Combined with Illumina’s Infrastructure, will Expand Biological Discovery and Clinical Insight. Long-Read Sequencing Market Opportunity Expected to Grow to $2.5B by 2022.

BioGX Celebrates Success of Global Partnership Initiative, Announces New Distribution Partnerships in EMEA and Asia-Pacific

1 November 2018

Vela Diagnostics Collaborating with Mayo Clinic to Research Sentosa® SQ HCV Genotyping Assay

30 October 2018 - Vela Diagnostics collaboration with U.S.-based Mayo Clinic results in a new version of the Sentosa® SQ HCV Genotyping Assay* with improved reporting and data-interpretation features

VirClia solution for infectious disease testing

29 October 2018

Bio-Rad Receives U.S. FDA Clearance for the IH-Reader 24, Expanding the Company’s Offering for the Blood Typing Market

29 October 2018

Thermo Fisher Scientific Completes Acquisition of Advanced Bioprocessing from BD

25 October 2018

Abbott Introduces the Next Generation of Influenza A & B and Strep A Assays with Fastest-Ever Time to Molecular Results

25 October 2018 - New Assays empower clinicians to more quickly make the right diagnosis at the point-of-care and prescribe the right treatment

Siemens Healthineers and Healthy.io Align Expertise to Improve Kidney Disease Compliance with Home Testing

23 October 2018

BioGX Launches 5 new CE Mark IVD Tests, Expands Sexual Health Panels on the BD MAXTM

23 October 2018

Quest Diagnostics Acquires Hurley Medical Center's Outreach Laboratory Services Operation in Central Michigan

22 October 2018 - Relationship to expand access to quality, high value and innovative services for people in Flint and surrounding communities

New Study Shows Abbott's Novel Diagnostic Test has the Potential to Demonstrate Gold Standard Accuracy and Speed, Which Could Help Rule Out Heart Attacks Earlier at the Point of Care

17 October 2018 - Preliminary research indicates that a diagnostic test currently in development that is done at the patient's side in minutes, has similar accuracy to a High-sensitive Troponin Test for early rule out of a heart attack

BD launches molecular test for detecting tuberculosis and multi-drug resistant TB

16 October 2018 - BD MAX™ MDR-TB Panel Obtains CE-IVD Status in Europe

Abbott Names Robert B. Ford President, Chief Operating Officer

15 October 2018 - Mr. Ford, a 22-year Abbott veteran, is currently executive vice president of Medical Devices, Abbott's largest business. He will expand his current role, taking on responsibility for all of Abbott's operating businesses.

QIAGEN’s next-generation QIAstat-Dx system delivers fast, cost-effective diagnosis of gastrointestinal syndromes

15 October 2018 - New gastrointestinal panel includes comprehensive viral coverage and provides Sample to Insight workflows to clinics in Europe and Australia

Hologic's Panther Fusion® Bordetella Assay Now CE Marked in Europe

11 October 2018

Ortho Clinical Diagnostics Launches New MicroTip Partnership Assays with Diazyme Laboratories, Inc., ARK Diagnostics, Inc., and Sekisui Diagnostics LLC

8 October 2018 - Kappa Free Light Chain and Lambda Free Light Chain MPA Assays cleared for use in Diagnosing and Monitoring Plasma Cell Disorders, Neoplastic Diseases; Methotrexate MPA Assay cleared for use in Monitoring Therapeutic Levels of Methotrexate

Combined testing of troponin and copeptin at admission shows potential to save time and costs in acute care and for the entire hospital stay

8 October 2018 - Analysis shows the earlier identification and rule-out of patients without acute myocardial infarction are the key enablers of positive economic outcome

Siemens Healthineers celebrates the opening of its new corporate headquarters in Erlangen

5 October 2018 - New office building marks the continuation of more than 140 years of company tradition in Erlangen - Modern and generous office space for up to 1000 employees

In vitro diagnostics company Sysmex Europe announces executive leadership change

2 October 2018

Thermo Fisher Scientific Announces Sixth Licensing Agreement for B•R•A•H•M•S PCT

2 October 2018 - Siemens Healthineers Recent FDA Clearance of the Atellica IM B•R•A•H•M•S PCT Assay Extends Access of Procalcitonin to More U.S. Laboratories

Abbott′s FreeStyle® Libre 2, with Optional Real-Time Alarms, Secures CE Mark for Use in Europe

1 October 2018 - New features further enhance Abbott′s market leading sensor-based continuous glucose monitoring technology - System offers optional low and high glucose alarms for people with diabetes at no additional cost

Abbott Receives CE Mark for First Troponin Test to Help Predict the Chance of Heart Attack in Apparently Healthy Adults Potentially Months to Years in Advance

26 September 2018 - Research shows adding Abbott's High Sensitive Troponin-I diagnostic test to doctors' existing standard of care can help more accurately determine a person's chances of a heart attack or other cardiac event potentially months to years in advance. Physicians now have a blood test that looks at a biomarker from the heart, so people can confidently take the appropriate lifestyle and medical steps needed to help prevent heart disease.

Ortho Clinical Diagnostics Launches New VITROS® Anti-T. cruzi Assay

24 September 2018

Beckman Coulter Receives Health Canada’s Medical Device License Approval for DxH 900 Hematology Analyzer and Early Sepsis Indicator

24 September 2018 - Featuring innovative technology, these diagnostic tools will help enhance analysis and detection for critical blood-based conditions and diseases for patients across the country

Cepheid Receives CE-IVD clearance for Xpert HCV VL Fingerstick

19 September 2018 - Enables Hepatitis C Point-of-Care molecular testing and linkage to care.

LGC announces VALIDATE® hsTnT kit for easier linearity and calibration verification on Roche cobas® analyzers

18 September 2018

QIAGEN and DiaSorin launch automated testing for latent TB infection with QuantiFERON-TB Gold Plus technology on widely used LIAISON platforms

17 September 2018 - CE-marked workflow enables efficient, high-throughput screening for tuberculosis control efforts in Europe and other markets; introduction in United States expected in 2019 and China in 2020

Roche ranked the most sustainable healthcare company in the Dow Jones Sustainability Indices for the tenth year running

13 September 2018

Thermo Fisher Scientific Board Authorizes $2 Billion of Share Repurchases

7 September 2018

Thermo Fisher Scientific to Acquire Advanced Bioprocessing Business from BD

7 September 2018

First-Half 2018 Results

5 September 2018 - First-Half 2018 Results

Sysmex, Toppan Printing, and RIKEN GENESIS Commence Launch of Fully Automated System (Research Use Only) to Detect Gene Mutations in Cancer Tissue

31 August 2018 - Streamlining the Gene Testing Processes to Standardize the Testing

Quidel Receives FDA Clearance, CLIA Waiver for Its Point-of-Care Sofia® 2 Lyme Fluorescent Immunoassay for Use with Sofia® 2 Instrument from Finger-Stick Whole Blood Specimens

30 August 2018

The NML publishes first digital PCR reference method for quantifying a clinically relevant genetic change

22 August 2018 - NML scientists demonstrate quantification of DNA changes relevant to cancer treatment with dPCR

Final USPSTF Cervical Cancer Screening Recommendations Retain

21 August 2018

QIAGEN partners with The Scientific Group to expand commercial presence in Africa

20 August 2018 - Advancing science and healthcare in a region with increasing demands for modern molecular testing solutions

Genedrive Partners With Find To Evaluate A Molecular Diagnostic Kit For Hepatitis C Virus In Decentralised Settings

8 August 2018

Sysmex Partec’s CyFlow™ Counter System, a System to Test for CD4+ Lymphocytes, Receives WHO Prequalification - Aiming to Help Improve the Quality of HIV Diagnosis and Treatment in Emerging Markets and

8 August 2018

Sysmex and JVCKENWOOD Jointly Establish Company to Use Micro and Nano-Fabrication Technology to Develop and Manufacture IVD Biodevices

7 August 2018

Hologic Announces FDA Clearance of the Panther Fusion® GBS Assay

2 August 2018 - System's Latest Assay Increases Lab Efficiency and Flexibility With Highly Sensitive and Specific Detection

QIAGEN’s careHPV™ Test wins WHO prequalification status for cervical cancer screening

1 August 2018 - WHO Prequalification recognizes the important role that the careHPV Test can have in screening women in emerging countries for HPV

Early Adopters Say Atellica Solution Exceeds Their Performance Expectations and Delivers Unprecedented Efficiencies

31 July 2018 - 70th AACC Annual Scientific Meeting & Clinical Lab Expo, Booth #2812

New Phadia 200 Advances In-vitro Diagnostics in Europe for Allergy and Autoimmune Conditions

31 July 2018

2018 Press Releases July 27, 2018 - Beckman Coulter and U.S. ARKRAY, Inc., Announce Partnership and Launch of the iQ Workcell to Deliver Scalable, Harmonized Solutions in the United States

27 July 2018 - Industry-leading iQ200 urine microscopy and AUTION MAX™ AX-4030 urine chemistry technology offer scalable, harmonized solution to meet customer needs

Hologic's Global Access Initiative Increases Availability of Diagnostic Testing in Resource-Limited Countries

25 July 2018 - Program focuses on infectious disease assays - including HIV - for countries where critical testing is needed most

Abbott Introduces Breakthrough Point-of-Care Test, the m-PIMA™ HIV-1/2 Viral Load (VL), at AIDS 2018 Amsterdam

24 July 2018 - New point-of-care diagnostic solution aims to make effective care more accessible for millions of HIV patient consistent with UNAIDS’ 90-90-90 goals

New Thermo Scientific B•R•A•H•M•S PCT direct blood test allows fast bacterial infection and sepsis diagnosis at patient's point of care

17 July 2018 - The new B•R•A•H•M•S PCT direct point of care assay requires just one drop of blood for a reliable infection diagnosis and clinical decisions in the acute care setting within 20 minutes

Quidel Receives FDA Clearance for Solana® Bordetella Complete® Molecular Diagnostic Assay for the Detection of Pertussis (Whooping Cough), Parapertussis Infections

16 July 2018

QIAGEN partners with U.K. to expand biomarker research in Manchester

11 July 2018 - Public-private alliances will create world-leading genomics campus and accelerate commercialization

PerkinElmer and Women & Infants Hospital of Rhode Island Launch Trial to Evaluate Performance Characteristics for High-Volume Non-Invasive Prenatal Testing Platform

10 July 2018

Sysmex Establishes Subsidiary in Egypt and Begins Conducting Direct Sales and Services

10 July 2018 - Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) has established a new subsidiary in Egypt and will begin conducting direct sales and services with the aim of expanding its business in the Middle East.

BD, Heart to Heart International and the NAFC Announce 2018 Grantees for a Multi-Year Point of Care Testing Initiative to Improve Patient Outcomes

27 June 2018 - BD, Heart to Heart International and the NAFC Announce 2018 Grantees for a Multi-Year Point of Care Testing Initiative to Improve Patient Outcomes

Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance for High-sensitivity Access hsTnI Assay

27 June 2018 - First high-sensitivity troponin I assay available in the United States enables clinicians to provide efficiency improvements in cardiac patient management

New Late-Breaking Data at ADA Underscore Significant Benefits of Abbott's FreeStyle Libre System for People Living with Diabetes

25 June 2018 - Expanded Real-World Evidence from More than 250,000 individuals using Freestyle libre system Showed Higher Frequency Scanning is Associated with improved glucose control, decreased glucose variability and reduced incidence of both daytime and nocturnal hypoglycemia

Vela Buys Great Basin Scientific

21 June 2018 - Adds 6 FDA Approved Products on a Medium Multiplexing Platform and Microbiology Know-how Enabling our Customers to Benefit from a New Sample-to-Result Solution Cost-Efficiently in Near Patient Care Setting; adds a Manufacturing and R&D site in Salt Lake City, UT, United States

Abbott Receives FDA Clearance for Afinion™ HbA1c Dx for Diagnosing Diabetes

21 June 2018 - The first-ever point-of-care HbA1c assay cleared for diagnosing diabetes and identifying patients at risk for diabetes

Grant to develop and implement a point-of-care test in the NHS to avoid antibiotic-related hearing loss in newborn children

20 June 2018

Health Canada Licenses Beckman Coulter’s Access Sensitive Estradiol Assay

20 June 2018 - The new Access Sensitive Estradiol assay completes the comprehensive reproductive menu for Access immunoassay systems and provides better operational efficiency while delivering quality results.

New Thermo Scientific B R A H M S KRYPTOR GOLD Analyzer Instrument Combines Higher Throughput and Maximum Autonomy

20 June 2018 - New KRYPTOR GOLD instrument features the precision and productivity required for clinical specialty diagnostics laboratories and patient diagnosis and prognosis research

Pivotal Study Reveals Effectiveness of Blood Tests in Screening for Sleep Apnea in Adult Males

19 June 2018 - Published findings show initial testing for three specific biomarkers may provide superior results over standard screening methods

Hologic’s New Panther Fusion® System, Flu and Respiratory Assays Now Approved by Health Canada

18 June 2018 - New Module Expands Molecular Testing Capabilities, Increases Productivity and Flexibility for the Laboratory

PerkinElmer’s EUROIMMUN Receives 510(k) Clearance for Crithidia luciliae and Crithidia luciliae Sensitive Diagnostic Tests

18 June 2018 - Testing Performed Together with EUROPattern System Can Help Accelerate Lupus Diagnosis

NEPHROCHECK® Biomarkers TIMP-2 and IGFBP7 Included in Acute Dialysis Quality Initiative Recommendations

12 June 2018 - The biomarkers in the NEPHROCHECK® test, an FDA-cleared and CE-marked urine test that indicates kidney stress in advance of acute kidney injury (AKI), have been included in a second set of consensus recommendations, the Acute Dialysis Quality Initiative (ADQI).

Abbott Introduces the Afinion™ 2 Analyzer Rapid Test System for Diabetes Management

31 May 2018 - State-of-the-Art multi-assay test system helps people with diabetes get the HbA1c results they need within 3 minutes -- allowing more time for consultation and care during a single healthcare visit

Beckman Coulter Diagnostics Launches New Hematology Analyzer Software to Help Laboratories Deliver Quality Results with Greater Productivity

10 May 2018 - Software version 2 enhancements improve flagging and streamline the quality control processes

Bio-Rad Reports First-Quarter 2018 Financial Results

8 May 2018

Beckman Coulter archieves CE Mark for its Early Sepsis Indicator

3 May 2018 - First-of-its-kind hematology-based test intended to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis as part of a routine CBC with differential test

Siemens Healthineers fully on track to meet the targets

3 May 2018

NEPHROCHECK Biomarkers TIMP-2 and IGFBP7 Included in Groundbreaking Consensus Statement of Best Practices to Enhance Recovery after Heart Surgery

2 May 2018

Sysmex to Launch JICA Project in the Republic of Ghana: Collaboration Program for Disseminating Automated Urinalysis Diagnosis Technology

26 April 2018

Sanquin Selects Abbott's Alinity s-Solution for Blood and Plasma Screening

23 April 2018 - Long-term agreement between Sanquin, a leader in blood services, and Abbott, a global leader in transfusion mecicine, helps ensure a safe and efficient blood supply in the Netherlands

Beckman Coulter Diagnostics Announces Worldwide Commercialization of the Access Sensitive Estradiol

10 April 2018 - The new Access Sensitive Estradiol assay rounds out the comprehensive reproductive menu for the Access immunoassay systems and provides better operational efficiency while delivering quality results

Roche completes acquisition of Flatiron Health

6 April 2018

bioMérieux reinforces its offering of High Medical Value immunoassay biomarkers with the acquisition of Astute Medical

4 April 2018

Spit test for Zika evolves from HIV detection

27 February 2018 - Researchers are developing a test for Zika that uses saliva to identify diagnostic markers of the virus much more quickly than current commercial tests can.

PerkinElmer Acquires Australian Single-Cell Genomics Firm RHS

27 February 2018 - Australian single-cell genomics technology developer RHS announced yesterday that it has been acquired by PerkinElmer for approximately A$25.2 million ($19.6 million).

Bio-Rad Q4 Revenues Up 9 Percent

27 February 2018 - io-Rad Laboratories said after the close of the market on Tuesday that its fourth quarter revenues grew almost 9 percent year over year, boosted by its life science segment.

Genedrive Awarded £1.1M for TB Test Development

27 February 2018 - Genedrive has been awarded a £1.1 million ($1.5 million) grant from Innovate UK to further develop its molecular diagnostic assay system for tuberculosis and rifampin resistance.

BGI, Ethiopian Biotechnology Institute to Collaborate on Genomics Research

23 February 2018 - BGI and the Ethiopian Biotechnology Institute (EBTi) said yesterday that they have signed a memorandum of understanding on collaborating in genomics and biotechnology.

Quidel Q4 Revenues Double on Triage Acquisition, Full-Year Revenues Up 45 Percent

BD Gets CE Mark for Circulating Cell-Free DNA Blood-Collection Tube

20 February 2018 - Becton Dickinson said today that the PAXgene Blood ccfDNA tube has received CE-IVD marking and is commercially available within Western Europe.

Ancient Indigenous Caribbean Genome Shows Close Relation to Modern Populations

LGC Acquires Lucigen

16 February 2018 - LGC said today that it has acquired Lucigen, a developer, manufacturer, and supplier of molecular biology enzymes, reagents, and kits, for an undisclosed amount.

FDA Clears Roche Factor II, Factor V Gene Mutation Test for Inherited Thrombophilia

13 February 2018 - Roche said today that the US Food and Drug Administration has granted clearance for its multiplex Factor II and Factor V test for use on the Cobas 4800 system, which performs real-time PCR analysis for mid- to high-volume labs.

Search of Soil Microbiome Turns Up New Class of Antibiotics Called Malacidins

12 February 2018 - By scouring the content of soil microbiomes, researchers have uncovered a new class of antibiotic.

Luminex Q4 Revenues Up 8 Percent Driven by Assay Sales

12 February 2018 - Luminex reported after the close of the market Monday that its fourth quarter revenues rose 8 percent year over year, in line with preliminary estimates.

BioGx, Launch Diagnostics Sign Distribution Agreement

08 February 2018 - BioGx announced today that UK-based firm Launch Diagnostics will distribute assay products from BioGx's European-based subsidiary in the UK and Ireland.

Vela Diagnostics HSV Test Gets FDA Clearance

08 February 2018 - The US Food and Drug Administration has cleared a herpes simplex virus (HSV) assay from Vela Diagnostics, the firm announced today.

Hologic Q1 Revenues Grow 8 Percent on Breast Health, MDx, and International Sales Strength

08 February 2018 - Hologic reported after the close of the market Thursday that revenues for its first quarter of fiscal year 2018 were up 8 percent year over year, driven by strength in breast health, molecular diagnostics, and its international businesses.

Q Biomed Options Glaucoma Biomarker From WUSTL

08 February 2018 - Biomedical technology accelerator Q Biomed announced today that it has acquired an exclusive option to a novel gene biomarker for glaucoma from Washington University in St. Louis.

New Targets Set To End Childhood AIDS By Year 2030

03 February 2018 - African First Ladies on Monday agreed to champion 'Free to Shine', a continental campaign aimed at ending childhood AIDS in Africa by 2030 and to keep mothers healthy.

Qiagen Reports 8 Percent Q4 Revenue Growth; Will Acquire Stat-Dx for Up To $191M

31 January 2018 - Qiagen said after the close of the market on Wednesday that its fourth quarter revenues grew 8 percent year over year as the firm beat analysts' consensus estimates on the top and bottom lines.

Life Sciences, Diagnostics Drive Danaher Q4 Revenues Up 11 Percent

30 January 2018 - Danaher today reported an 11 percent year-over-year increase in its fourth quarter revenues, with its Life Sciences and Diagnostics segments growing above the companywide rate.

Illumina's Q4 Revenues Climb 26 Percent

30 January 2018 - Illumina reported after the close of the market Tuesday that its fourth quarter 2017 revenues grew 26 percent over Q4 2016.

OAFLA and the African Union Launch the 'Free To Shine' Campaign that Aims to Help Prevent New HIV Infections and Childhood Deaths

29 January 2018 - Abbott

FDA is extending two of its draft guidances

26 January 2018 - FDA said this week it is extending the comment period for two of its draft guidances

Illumina Awarded $26.7M in NIPT Patent Suit Against Ariosa

26 January 2018 - Illumina has won a patent infringement lawsuit against Roche's Ariosa Diagnostics related to the companies' noninvasive prenatal tests. A jury in the US District Court of the Northern District of California awarded Illumina $26.7 million in damages.

PerkinElmer Q4 Revenues Up 13 Percent

25 January 2018 - PerkinElmer reported after the close of the market on Thursday that its fourth quarter revenues rose 13 percent year over year, led by 23 percent growth in its diagnostics business.

Roche Cobas TV/MG Test Gets CE-IVD Mark

24 January 2018 - Roche today announced it received the CE-IVD mark for the Cobas TV/MG test for use on the Cobas 6800/8800 systems.

Mesa Biotech Point-of-Care Testing Platform Garners CE Mark

24 January 2018 - Mesa Biotech said today that its PCR testing platform for point-of-care infectious disease testing has obtained CE marking in the EU.

Cell Microsystems Continues Single-Cell RNA-Seq Development Under $1.5M NIH Grant

23 January 2018 - Cell Microsystems said today that it has been awarded a $1.5 million SBIR grant from National Institutes of Health, under which it will continue to develop its CellRaft technology and related methods for analyzing single cells.

Thermo Fisher Scientific Loans Premaitha $3M to Fund Litigation With Illumina

22 January 2017 - UK prenatal diagnostics company Premaitha Health has received a £1.2 million ($3 million) loan from Thermo Fisher Scientific to cover legal costs related to its ongoing patent litigation with Illumina, the company said today.

Hologic Completes $1B Senior Notes Placement

19 January 2018 - Hologic said Friday that it has completed a previously announced private placement of $1 billion in senior notes.

Lucigen Inks Global Distribution Deals

17 January 2018 - Lucigen announced today it has expanded its global operations with the appointment of four new distributors.

Qiagen, HTG Molecular Begin Third Project Under CDx Development Pact

16 January 2017 - HTG Molecular Diagnostics said today that it has entered into a third project for a new clinical assay development program under an existing master assay development, commercialization, and manufacturing agreement with Qiagen.

BD, Check-Points Receive CE Mark for Resistant Organism NGS Screening Test

15 January 2018 - Becton Dickinson and Netherlands-based Check-Points Health have received CE marking for a next-generation sequencing-based screening test for antibiotic-resistant carbapenemase-producing organisms (CPOs). 

Malaria Parasite Sequences Highlight Drug Resistance Mutations, Potential Treatment Targets

11 January 2018 - A University of California, San Diego-led team has tallied up drug resistance mechanisms — and started searching for new treatment targets — in the Plasmodium falciparum malaria parasite.

ThermaGenix, MilliporeSigma Ink PCR Reagents Distribution Deal

10 January 2018 - ThermaGenix has signed a global distribution agreement for its PCR improvement reagents with MilliporeSigma, the US operation of Merck KGaA's life science business.

Thermo Fisher Launches New Sequencing Instruments, Readies Clinical Mass Spec System

10 January 2018 - Thermo Fisher Scientific has launched two new sequencing instruments based on its semiconductor sequencing technology — the Ion GeneStudio S5 Prime and the Ion GeneStudio S5 Plus.

Illumina Launches Semiconductor Sequencer, Partners With Thermo Fisher, Releases Prelim Earnings

09 January 2018 - Illumina unveiled on Monday the semiconductor-based sequencing system that it has been developing as part of its previously discussed Firefly project.

Abbott and YRGCARE collaborate to study HIV and viral hepatitis patterns in India

09 January 2018 - People who inject drugs (PWID) and sex workers are identified as key affected populations for which the epidemic is growing.

Regeneron Partners With AbbVie, Alnylam, AstraZeneca, Biogen, Pfizer to Sequence UK Biobank Samples

08 January 2018 - Regeneron Pharmaceuticals said today that it has formed a pre-competitive consortium with AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen, and Pfizer to sequence the exomes of all 500,000 participants in the UK Biobank.

TAI Diagnostics Closes $10M Series A Financing; Partners With United Therapeutics

08 Jauary 2018 - TAI Diagnostics, a developer of diagnostic tests for monitoring the health of transplanted organs, said on Monday that it has closed a $10 million Series A preferred equity financing.

Quidel Completes Sale of Alere Real Estate Asset for $149M

05 January 2018 - Quidel announced today it has completed the sale of its newly-acquired Summers Ridge campus for $148.7 million, including $142 million in immediately available net cash.

Evercore ISI Initiates Coverage of Nine Life Science Tools and Diagnostic Firms

04 January 2018 - Investment bank Evercore ISI said today it has initiated coverage of nine life science tools and diagnostic firms with Illumina, Qiagen, Danaher, and Thermo Fisher Scientific among its top picks.

Applied Biocode Submits MDx Platform, GI Panel for 510(k) Clearance

04 January 2018 - Applied Biocode has submitted a high-volume molecular testing platform and a gastrointestinal panel to the US Food and Drug Administration for 510(k) clearance following recently completed clinical trials, the company announced today.

Roche launches the cobas Plasma Separation Card to increase access to HIV testing for patients living in remote areas

04 January 2018 - Roche launches the cobas Plasma Separation Card to increase access to HIV testing for patients living in remote areas.

GenScript to acquire CustomArray

27 December 2017 - GenScript Biotech announced today an agreement to acquire CustomArray for an undisclosed sum.

Quidel provides update on Triage acquisition, Legacy business

20 December 2017 - In an amended 8K filed with the US Securities and Exchange Commission late yesterday, Quidel provided detail on its acquisition of the Alere Triage and BNP businesses from Abbott, and provided updates on its legacy business and recent influenza testing tracking.

Horizon expands agreement with Roche Diagnostics

18 December 2017 - Cambridge, UK-based Horizon Discovery has expanded its relationship with Roche Diagnostics with a new agreement to assist in the development of immunohistochemistry (IHC) assays.

Siemens Healthineers announces acquisition of Fast Track Diagnostics

15 December 2017 - Siemens Healthineers has signed an agreement to acquire Luxembourg-based Fast Track Diagnostics (FTD), a global supplier of molecular diagnostic tests.

Proteomics International to test Kidney Disease Test as CDx for Investigational Treatment

14 December 2017 - Proteomics International Laboratories announced today that it has signed an agreement to evaluate its PromarkerD test in clinical trials of Dimerix's investigational chronic kidney disease drug DMX-200.

Molzym automated pathogen enrichment and PCR test, Micro-Dx™, gets CE mark for In vitro diagnostics

09 November 2017 - Molzym announces CE IVD marking of their robotic microbial DNA isolation and direct PCR test, Micro-Dx™, for routine pathogen diagnosis.

Hologic Q4 revenues rise 11 %

08 November 2017 - Hologic reported after the close of the market on Wednesday that its fourth quarter revenues rose 11 percent, driven in part by double-digit growth in its molecular diagnostics business.

Qiagen launched a custom solutions business

03 November 2017 - Qiagen this week launched a custom solutions business to provide life sciences and molecular diagnostics companies with tools and expertise to quickly build and commercialize products.

Bio-Rad Q3 revenues grow 5 %

02 November 2017 - Bio-Rad said after the close of the market Thursday that its third quarter revenues increased 5 percent year over year.

Abbott announces FDA clearance for its Alinity™ CI-series next-generation diagnostic systems

31 October 2017 - Innovative, harmonized solutions for clinical chemistry and immunoassay testing will help laboratories and hospital systems achieve measurably better healthcare performance

Pillar Biosciences, Illumina partner on IVD development

26 October 2017 - Cancer diagnostics firm Pillar Biosciences has partnered with Illumina to develop next-generation sequencing-based in vitro diagnostics, the companies announced today.

Roche Diagnostics revenues grow 5 % in first 9 months of 2017

19 October 2017 - Roche said today that its diagnostics division revenues grew 5 percent in the first nine months of 2017, driven by growth in immunodiagnostics and in the rest of its centralized and point-of-care solutions business.

BioMérieux Q3 sales up 6 %

18 October 2017 - BioMérieux reported today that its third quarter revenues rose 6 percent from Q3 2016, including a 23 percent increase in molecular biology sales, and boosted by a period of fast-paced growth for the BioFire FilmArray product line both in the United States and in the rest of the world.

Abbott reports 5 % Q3 Dx growth on strong core lab, point-of-care sales

18 October 2017 - Abbott today said that its Diagnostics business grew sales 5 percent year over year in the third quarter, driven in part by strong growth in its core laboratory and point-of-care tests.

FDA clears Roche C. difficile assay for liat platform

09 October 2017 - The US Food and Drug Administration cleared Roche's Cobas Cdiff Nucleic acid test last month for the detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile, the agency said on its website.

FDA approves Roche Zika virus assay for blood donation screening

06 October 2017 - The US Food and Drug Administration on Thursday announced that it has approved Roche's Cobas Zika test for detecting the virus in blood donations.

Global Polymerase Chain Reaction (PCR) Technologies Market Analysis & Trends to 2025

04 October 2017 - The Global Polymerase Chain Reaction (PCR) Technologies Market is poised to grow at a CAGR of around 7.9% over the next decade to reach approximately $16.4 billion by 2025.

Roche to initiate blood sample screening for Babesia under IND

03 October 2017 - Roche said today that it plans to immediately initiate screening of blood samples with its Cobas Babesia test under an investigational new drug application protocol, and it is working with designated study sites in the US to commence testing.

Abbott completes Alere acquisition

03 October 2017 - Abbott said today in a filing with the US Securities and Exchange Commission that it has completed its acquisition of Alere, concluding a deal first announced in February 2016.

Abbott extends tender offer for Alere preferred stock

02 October 2017 - Abbott today extended its tender offer to purchase all outstanding shares of Alere's Series B convertible perpetual preferred stock at $402 per share.

UgenTec, R-Biopharm Collaborate to Develop Software for Automated PCR Analysis

21 September 2017 - UgenTec announced today that it has agreed to collaborate with R-Biopharm AG to develop an interpretation software for that company's clinical PCR kits.

Rosetta Genomics Inks Deal to Sell PersonalizeDx for $2.9M

08 September 2017 - Rosetta Genomics said today that it has agreed to sell its PersonalizeDx unit to healthcare business group Pragmin Prognosis for $2.9 million in cash.

Bruker receives FDA approval for expanded MALDI biotyper

31 July 2017 - Bruker said today it has received US Food and Drug Administration clearance for a third, expanded version of its MALDI Biotyper system.

BioMérieux gets FDA approval for expanded Vitek MS rapid pathogen identification

31 July 2017 - BioMérieux said today that the Vitek MS MALDI-TOF Mass Spectrometry System for rapid pathogen identification has received 510(k) clearance from the US Food and Drug Administration for the expanded identification of mycobacteria, Nocardia,and molds.

Roche diagnostics revenues up 5 % in first half

27 July 2017 - Roche reported on Thursday a 5 percent increase in its Diagnostics division revenues for the first half of 2017, driven by strong growth in tissue diagnostics and centralized and point-of-care solutions.

Roche includes cobas HIV-1/HIV-2 test in Global Access Program

25 July 2017 - Roche announced today the inclusion of its Cobas HIV-1/HIV-2 nucleic acid test in its Global Access Program.

DiaSorin to acquire ELISA immunodiagnostic business portfolio and associated assets from SIEMENS HEALTHINEERS

25 July 2017 - DiaSorin S.p.A. (FTSE Italia Mid Cap: DIA) and Siemens Healthcare GmbH announce that they have signed a binding agreement pursuant to which DiaSorin will acquire from Siemens Healthcare GmbH and affiliated companies (“Siemens Healthineers”) its micro-titre based ELISA immunodiagnostic business portfolio and related tangible and intangible assets.

Luminex corporation receives FDA clearance for ARIES C. difficile assay

24 July 2017 - Luminex Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for the ARIES® C. difficile Assay, a moderate complexity, sample to answer test for rapid detection of C. difficile.

Abbott Dx revenues rise 4 % in Q2 on strong core lab and point-of-care growth

20 July 2017 - Abbott today said that its Diagnostics business grew sales 4 percent year over year in the second quarter, driven in part by strong growth in for its core laboratory and point-of-care tests.

Alere shareholders say yes to Abbott merger

07 July 2017 - Alere late Friday said that its shareholders approved the company's amended merger with Abbott.

Promega to seek FDA approval, CE-IVD mark for microsatellite instability assay

06 July 2017 - Promega said today that it intends to seek US Food and Drug Administration approval and CE-IVD marking for its microsatellite instability assay to help oncologists and pathologists make treatment decisions for colorectal cancer patients.

FDA approves Abbott's molecular CMV assay

27 June 2017 - Abbott today announced the US Food and Drug Administration approved its RealTime CMV molecular test, the only commercially available cytomegalovirus test that can amplify two select regions of the CMV genome, according to the company.

Mobidiag gets CE-IVD mark for GI virus test

26 June 2017 - Finnish molecular diagnostics firm Mobidiag said today that its Amplidiag Viral GE gastrointestinal virus test has received CE-IVD marking and is now available in Europe.

DiaSorin and Tecan to collaborate in new platform development

23 June 2017 - Tecan Group AG / DiaSorin and Tecan to collaborate in new platform development . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

First ultra-sensitive cardiac troponin (cTnI) test using Single Molecule Counting technology receives CE Mark

01 June 2017 – Singulex, a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of protein biomarkers, today announced it has applied the CE Mark to its ultra-sensitive troponin I assay (cTnl), the first offered on the Sgx Clarity® system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.

Genomic studies untangle Zika virus introduction, spread across Americas

24 May 2017 - Three independent research teams took a genomic look at the Zika virus (ZIKV) for a collection of interrelated studies, using sequences from hundreds of clinical and Aedes aegypti mosquito ZIKV samples to track the origins and spread of the 2015 Zika outbreak.

FDA approves first drug for tumor's biomarker indication

23 May 2017 - The US Food and Drug Administration has for the first time approved a drug to be given based on the genomic features in cancer patients' tumors, instead of where the tumor occurs in their bodies.

Rosetta Genomics plans to sell PersonalizeDx Business

22 May 2017 - Rosetta Genomics said today that it intends to sell its PersonalizeDx business as part of an ongoing effort to focus on its microRNA-based thyroid nodule classification assay, RosettaGx Reveal.

French Health Authority recommends NIPT for Trisomy 21 after first trimester combined screen

19 May 2017 - The French National Authority for Health (HAS) earlier this week published a public health recommendation that advises to make circulating cell-free DNA testing for fetal trisomy 21 in maternal blood available to all pregnant women if their first trimester combined screen indicates an increased risk.

EntroGen receives CE-IVD mark for BRCA complete test

18 May 2017 - EntroGen said today that it has received CE-IVD marking for its BRCA Complete kit for exome sequencing of the BRCA1 and BRCA2 genes.

Thermo Fisher buying pharma contract development and manufacturing firm patheon for $7.2B

15 May 2017 - Thermo Fisher Scientific said today it is acquiring contract development and manufacturing organization (CDMO) Patheon for roughly $7.2 billion.

Quidel Solana Clostridium difficile test clears FDA

11 May 2017 - Quidel has received 510(k) clearance from the US Food and Drug Administration for a molecular assay for the qualitative detection of Clostridium difficile.

Hologic Q2 revenues Up 3 % - beat estimates

10 May 2017 - Hologic reported after the close of the market on Wednesday that its second quarter revenues rose 3 percent, driven in part by solid growth in molecular diagnostics.

Grifols Babesia assay gets IND for blood bank screening

09 May 2017 - An assay from Grifols to detect four species of Babesia can now be used under a US Food and Drug Administration Investigational New Drug study for blood screening at selected US blood banks.

Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test in urothelial carcinoma

02 May 2017 - Roche today announced approval of the VENTANA PD-L1 (SP263) Assay by the US Food and Drug Administration (FDA) as a complementary diagnostic3 to provide PD-L1 status for patients with locally advanced or metastatic urothelial carcinoma (mUC)4 who are being considered for treatment with the FDA-approved anti-PD-L1 immunotherapy IMFINZI™ (durvalumab, AstraZeneca).

FDA Approves Roche's PD-L1 Test for Bladder Cancer

02 May 2017 - Roche on Tuesday said that its PD-L1 assay was approved by the US Food and Drug Administration as a complementary diagnostic for patients with locally advanced or metastatic urothelial carcinoma who are being considered for treatment with AstraZeneca's immunotherapy Imfinzi (durvalumab).

Becton Dickinson Q2 revenues down 3 despite life sciences growth

02 May 2017 - Becton Dickinson reported today that its fiscal second quarter revenues were down 3 percent year over year, reflecting the divestiture of its respiratory solutions business completed in October 2016. On a comparable, currency-neutral basis, Q2 revenues grew 5 percent, BD said.

Roche Q1 diagnostics revenues up 6 %

27 April 2017 - Roche said today that its diagnostics revenues grew 6 percent year over year for the first quarter of 2017, driven by growth in its centralized and point-of-care solutions segment.

Roche's diagnostic sales rise 6 % in first quarter

27 April 2017 - Roche announced Thursday that first-quarter sales in its diagnostics division rose 6 percent year-over-year to 2.8 billion Swiss francs ($2.8 billion), mainly due to immunodiagnostic solutions.

Hologic Q2 revenues up 6 %

27 April 2017 - Hologic reported after the close of the market on Wednesday that its second quarter revenues rose nearly 6 percent thanks in large part to a double-digit growth in its US business.

LabCorp Q1 revenues grow 5%

26 April 2017 - Laboratory Corporation of America today reported that its net revenues for the first quarter grew 5 percent year over year, while its diagnostics segment improved 8 percent.

Abbott, Alere agree to lower acquisition price to $5.3B

14 April 2017 - Abbott and Alere said today that they have agreed to amend the terms of their acquisition agreement and dismiss lawsuits they had filed against each other.

Roche launches cobas Liat PCR System with four assays into CE-markets

03 April 2017 - Roche today announced the CE-IVD launch of the cobas® Liat® PCR System with four assays including first 20 minute real-time PCR nucleic acid test to detect Clostridium difficile (C. diff).

Q&A: Labceutics' Jordan Clark on Industry, FDA Gap on Rx/Dx codevelopment principles

28 February 2017 - The US Food and Drug Administration last year issued a long-awaited draft guidance outlining the principles for simultaneously developing a drug and diagnostic — the paradigm that the agency has maintained is the ideal way to get a personalized medicine product to market.

Bio-Rad to acquire RainDance technologies

16 January 2017 - Bio-Rad Laboratories announced today that it has agreed to acquire rival droplet-based PCR systems manufacturer RainDance Technologies for an undisclosed amount. The acquisition is expected to close during the first quarter of 2017.

Luminex Gets FDA Clearance for Aries GBS Assay

04 January 2017 - Luminex announced today that it has received US Food and Drug Administration approval for its Aries Group B Streptococcus (GBS) assay for antepartum detection of GBS colonization in pregnant women.

Hologic HIV-1 quant test wins FDA clearance

03 January 2017 - A quantitative nucleic acid amplification test for HIV-1 from Hologic has been granted pre-market approval from the US Food and Drug Administration, the company announced today.

Abbott seeks to exit Alere deal

07 December 2016 - Abbott said today that it has filed a complaint in the Delaware Chancery Court to terminate its proposed $5.8 billion acquisition of Alere.

Danaher completes acquisition of Cepheid

07 November 2016 - Danaher announced Friday that it has completed its $4 billion acquisition of Cepheid.

Danaher acquisition of Cepheid clears antitrust requirements

24 October 2016 - Danaher's proposed $4 billion acquisition of Cepheid has cleared antitrust requirements, Cepheid announced today.

Cepheid leads GenomeWeb index in september on news of impending acquisition by Danaher

03 October 2016 - The GenomeWeb Index rose more than 5 percent in September, outperforming the Dow Jones Industrial Average, the Nasdaq, and the Nasdaq Biotechnology Index, and clawing back the 2 percent drop it saw in August.

Alere and Abbott end mediation without settlement

28 September 2016 - In a filing with the US Securities and Exchange Commission this week, Alere said that mediation between itself and Abbott Laboratories has concluded without resolution.

Bioneer gets Korean approval for Zika detection kit

09 September 2016 - South Korean molecular diagnostics firm Bioneer announced this week that it has received approval from the Korea Ministry of Food and Drug Safety for its AccuPower ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Zika virus detection kit.

FDA expands hologic Zika EUA to include urine testing

08 September 2016 - The US Food and Drug Administration has expanded the Emergency Use Authorization issued to Hologic's Aptima Zika test to include urine testing, the company announced today.

Danaher to acquire Cepheid for nearly $4 Billion in cash

06 September 2016 - Danaher said today that it plans to acquire Cepheid for nearly $4 billion in cash. The deal is expected to close by the end of the year.

Alere sues Abbott to move forward on merger

26 August 2016 - Alere said today that it has filed a complaint in Delaware Chancery Court in order to both compel Abbott to fulfill its obligations under the terms of their merger agreement, and to force Abbott to act promptly in obtaining the required anti-trust approvals.

Alere adamant Abbott can't avoid closing acquisition

09 August 2016 - Abbott has no basis to elude closing its pending acquisition of Alere, the Waltham, Massachusetts-based diagnostics firm claimed after Abbott said Alere's filing of its Form 10-K for 2015 did not eliminate some concerns it had about the deal.

Becton Dickinson gets CE mark for Vaginal Pathogen panel

13 May 2016 - Becton Dickinson announced today it has received CE marking for the BD Max Vaginal Panel.

Abbott attempted to terminate merger with Alere

28 April 2016 - Abbott Laboratories attempted to terminate its pending merger with Alere, Alere said late on Thursday. 

Roche to build Asia-Pacific production base in SIP

31 March 2016 - Roche Diagnostics Suzhou is to be built as the first Roche production base in the Asia-Pacific region.

Abbott to acquire Alere for $5.8B

01 February 2016 - Abbott has entered into a definitive agreement to acquire Alere for $5.8 billion, the companies said today.

Roche Diagnostics to build a manufacturing site in Suzhou

07 November 2014 - Roche Diagnostics has announced to establish a manufacturing site in Suzhou Industrial Park to focus on products for immunochemistry and clinical chemistry tests.