The Food and Drug Administration has rescinded its final rule on laboratory developed tests, formally ending a decades-long effort to expand oversight of the lab industry.

Qiagen is partnering with Oxford Gene Technology, a Sysmex subsidiary, to comarket and distribute its Qiagen Clinical Insight (QCI) Interpret software with OGT's SureSeq NGS panels, the firms announced Thursday. Financial terms were not disclosed.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has categorized its Ionify® 25-Hydroxy Vitamin D total assay as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This represents the first time a mass spectrometry-based test has achieved this designation, opening access to a broader range of clinical laboratories.

Original from: PR Newswire The Life Science division of Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced the launch of ..

Biocartis Group of Companies (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ CDx MSI Test developed in partnership with Bristol Myers Squibb, has received the first-ever Premarket Approval (PMA) from the FDA for a cartridge-based, fully automated, “sample-to-result” companion diagnostic test.

Roche (SIX: RO, ROG; OTCQX: RHHBY) shared real-world evidence from the rollout of Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution at the European Association for the Study of Diabetes (EASD) annual meeting today, and announced its integration with the mySugr diabetes management app, providing many more people with diabetes access to an AI-enabled predictive solution for the first time.

Digital pathology firm Proscia announced on Tuesday that it has expanded its collaboration with Amazon Web Services by integrating Proscia's Concentriq pathology platform with AWS HealthImaging, a service for storing and sharing whole-slide images in the cloud.

2.1.2 Registration of Instruments in Recent 2 Years China has been engaged in the R&D and manufacturing of semi-automatic coagulation analyzers for over a decade, and based on the data from the website of th..

Renalytix plc (LSE: RENX) (OTCQB: RNLXY), today announced an agreement with Tempus AI, Inc. (NASDAQ: TEM) to make kidneyintelX.dkd prognostic blood testing more widely available for eligible patients within its US network of healthcare institutions. Eligible patients have type 2 diabetes with chronic kidney disease, impacting nearly 15 million individuals in the US.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and OPKO Health, Inc. (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, announced today the completion of Labcorp's acquisition of select assets of BioReference Health, a wholly owned subsidiary of OPKO Health.

Turkey’s Minister of Health Kemal Memişoğlu Visits Mindray’s Shenzhen Headquarters with Delegation On September 11th, Turkey’s Minister of Health, Kemal Memişoğlu, v..

Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer diagnostics, today announced the launch of the Cancerguard™ test, a new multi-cancer early detection (MCED) blood test that is now available as a laboratory-developed test (LDT) in the United States. Cancerguard is the first MCED test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.

Researchers at the Johns Hopkins Kimmel Cancer Center, Johns Hopkins All Children’s Hospital and four other institutions have devised a novel method to test for prostate cancer using biomarkers present in urine, funded in part by the National Institutes of Health. This approach could significantly reduce the need for invasive, often painful biopsies, they say.

US drugmaker Merck has scrapped a £1bn London research centre and will lay off more than 100 scientific staff, as the industry accuses ministers of making the UK uncompetitive and paying too little for medicines.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it has reached a strategic agreement with LabFlorida/SunDx Labs to provide residents of senior living communities access to Guardant Shield™, the first blood test approved by the U.S. Food and Drug Administration (FDA) as a primary screening option for colorectal cancer (CRC). As part of the agreement, LabFlorida will serve as the exclusive distributor to senior living communities throughout Florida. LabFlorida/SunDX provides premier concierge-style lab testing, tailored specifically for assisted and independent living and homebound patients.