The U.S. Food and Drug Administration ("FDA") has granted QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho"), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the "VITROS hs Troponin I Assay"). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).

2.4.2 Existing Problems of Blood Coagulation Testing According to basic survey results, the existing main problems for coagulation testing include nonunified standardization, insufficient academic knowledge of b..

Wantai BioPharm and Jinyuan Xintong Forge Strategic Partnership to Advance High-Quality Development of Medical Laboratories On October 31, 2025, during the NCLM held in Jinan, China, Wanta..

Diasorin said Friday that it has secured US Food and Drug Administration 510(k) marketing clearance for a syndromic respiratory disease test.

Tosoh Bioscience, Inc., a market leader in clinical diagnostics has received U.S. FDA 510(k) clearance for its next-generation Tosoh Automated Glycohemoglobin Analyzer HLC®-723 GR01 (GR01) for HbA1c testing.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended September 30, 2025.

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, today announced financial results for the third quarter ended September 30, 2025.

Original from: Labcorp Updates Full-Year Guidance · Financial results from Operations for third quarter 2025 versus third quarter 2024: - Revenue: $3.56 billion versus $3.28 billion ..

Cepheid today announced that its Xpert® MTB/XDR test has been awarded prequalification status by the World Health Organization (WHO), marking a new milestone in the global fight against tuberculosis (TB). This designation affirms the test's compliance with the WHO's rigorous standards for quality, safety, and performance, and enables procurement through international agencies.

2.4 Existing Problems in the Blood Coagulation Industry and Influencing Factors 2.4.1 Implementation of in Vitro Diagnosis of Thrombosis and Hemostasis in the Chinese Market After 2000, more and mo..

Roche Diagnostics and HOB Biotech Signed a Five-Year Strategic Agreement to Launch Cooperation in Chemiluminescence Autoantibody Testing On October 21, 2025, Roche Diagnostics entered into a Cooperation F..

Fibronostics, a global leader in non-invasive diagnostics for metabolic and liver diseases, today announced the completion of its acquisition of Stone Clinical Laboratories, LLC, a leading provider of advanced laboratory services in the United States.

Revvity, Inc. (NYSE: RVTY), today reported financial results for the third quarter ended September 28, 2025.

Biodesix, Inc. (NYSE: BDSX), a leading diagnostics solutions company, today announced the signing of an expanded partnership agreement under which Biodesix will conduct the development, clinical validation, and regulatory submissions of in vitro diagnostic (IVD) assays to enable highly sensitive detection of multiple genomic markers focused on oncology applications, utilizing Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology on Bio-Rad’s QX600 platform. Following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits for the developed assays.

Thermo Fisher Scientific, the world leader in serving science, today introduced the Thermo Scientific™ Orbitrap Exploris™ EFOX Mass Detector, the industry’s first high-resolution accurate mass (HRAM) Orbitrap system designed specifically for environmental and food safety laboratories. The new system addresses urgent global challenges around food and water quality testing in the face of persistent contaminants, such as per- and polyfluoroalkyl substances (PFAS), pesticides and other pollutants. With tailor-made workflows and some of the strongest targeted analysis technology in the field, laboratories can use the Orbitrap Exploris EFOX (Environmental and Food Organic Xenobiotics) to generate richer, compliant data faster in order to assess public health risks sooner.