The US Food and Drug Administration (FDA) issued finalized guidance on Monday outlining the criteria for authorizing emergency use of unapproved in vitro diagnostic tests (IVDs) during future public health emergencies.

Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, and Agilent Technologies Inc. (NYSE: A), a global leader in life sciences, diagnostics, and applied chemical markets, today announced a nonexclusive collaboration to develop AI-based companion diagnostic solutions. The collaboration will leverage Lunit's AI technology and Agilent's expertise in tissue-based companion diagnostics to create advanced solutions that meet the demand of novel and complex biomarker assays in drug development.

Revvity, Inc. (NYSE: RVTY) announced a strategic collaboration with Profluent, bringing together a range of its novel AI-engineered enzymes with Revvity’s established Pin-pointTM base editing platform. The result is simplified access for customers to a therapeutically relevant base editing toolkit.

2.2 Blood Coagulation Reagents Thrombotic diseases, in particular cardiovascular and cerebrovascular thrombotic diseases, have become the top cause of death in the population of China, and their incidence has in..

Diasorin (FTSE MIB: DIA) today announces the launch of the new LIAISON® TSH-R Ab assay, available in all countries recognizing the CE Mark. This assay is specifically developed to aid in the diagnosis and monitoring of patients with suspected Graves’ Disease, an autoimmune disorder characterized by autoantibodies, TSH-Receptor antibodies (TSH-R Ab), that can stimulate thyroid receptors, leading to increased production and release of hormones by the gland.

The Food and Drug Administration has rescinded its final rule on laboratory developed tests, formally ending a decades-long effort to expand oversight of the lab industry.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