Biolinq Incorporated, a pioneering developer of precision multi-analyte biosensors to improve metabolic health, today announced the U.S. Food and Drug Administration has granted De Novo Classification for its lead product, Biolinq Shine™. With this classification, Biolinq has a clear path forward to scale a new generation of wearable sensors designed for comfort, simplicity, and global reach.

Hitachi High-Tech Corporation ("Hitachi High-Tech"), and ELITechGroup S.p.A. (Head Office: Italy, "ELITech") have entered a Collaboration, Manufacturing and Supply Agreement (the "Agreement") in the field of molecular testing for infectious disease.

As of August 31, 2025, China has 83 publicly listed companies related to in vitro diagnostics (IVD), including 62 whose core business is IVD and 21 with IVD-related operations. Among the 62 core IVD companies, 59 have..

Myriad Genetics (Nasdaq: MYGN), a leader in molecular diagnostic testing and precision medicine, and SOPHiA GENETICS (Nasdaq: SOPH), an AI technology company transforming precision medicine, announced a strategic collaboration to develop and provide pharmaceutical companies with an innovative global liquid biopsy companion diagnostic (CDx) test. This partnership will leverage Myriad’s advanced laboratory capabilities in the U.S. to support global testing for clinical trials and SOPHiA GENETICS’ broad, decentralized network of more than 800 connected institutions in more than 70 countries for global test deployment.

The U.S. Commerce Department said on Wednesday it has opened new national security investigations into the import of personal protective equipment, medical items, robotics and industrial machinery.

Shield is the first and only blood test to receive full FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. Through a multi-year agreement, Quest’s provider clients that order lab testing from Quest will be able to directly order Shield through their existing Quest account and electronic health record (EHR). Quest provided healthcare connectivity solutions to approximately 650,000 clinician and hospital accounts last year. Quest’s provider clients will also be able to refer patients to Quest’s 2,000 patient service centers and 6,000 in-office phlebotomists for blood draws in the United States. In addition, Quest’s national commercial sales team will proactively educate primary care physicians and obstetricians and gynecologists about the test, accelerating awareness among Quest’s ordering providers. Shield is expected to be available for physician order through Quest in the first quarter of 2026.

Riken Genesis Co., Ltd. (Riken Genesis) and Burning Rock Biotech Limited (NASDAQ: BNR, “Burning Rock”) today announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW).

Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RNA-based Tempus xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs.

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.