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 the NMPA, in 2024 and 2025 (as od 15 August), a total of 2 instruments from 2 manufacturers have obtained registration certificates...

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China. Latest news

Beckman Coulter Diagnostics, a Danaher company and a leader in global clinical diagnostics innovation, today launched the industry's first fully automated Brain-derived Tau (BD-Tau) research use only (RUO) immunoassay test. Access BD-Tau, along with Beckman Coulter Diagnostics' expanding portfolio of neurodegenerative disease RUO assays, is available for use on the groundbreaking DxI 9000 Immunoassay Analyzer and Access 2 Analyzer. This portfolio of assays enables precision medicine research on clinical-grade platforms for a variety of neurodegenerative diseases and includes p‑Tau217, NfL, GFAP and APOE ε4.

Altesa BioSciences, a clinical stage pharmaceutical company dedicated to preventing and treating rhinovirus infections, one of the leading causes of Chronic Obstructive Pulmonary Disease (COPD) and asthma exacerbations, today announced a partnership with bioMérieux, a world leader in the field of in vitro diagnostics, to utilize the BIOFIRE® SPOTFIRE® respiratory solution as its core point-of-care diagnostics platform at U.S. sites for Altesa’s upcoming Phase 2B clinical trial.

Epigenetics firm VolitionRx and Werfen said Tuesday that they have signed a licensing and commercialization deal covering the use of Volition's antiphospholipid syndrome (APS) test with Werfen's analyzers.

Different medical institutions have selected different imported and domestic brand instruments: 38 domestic and 58 imported.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a strategic partnership with PathGroup, one of the nation’s leading partners to physicians, hospitals, and healthcare networks nationwide, to significantly expand the reach of Guardant’s FDA-approved Shield™ blood test. The partnership will bring Shield to more than 250 hospitals and health systems, over 15,000 PathGroup-affiliated physicians across 25 states, and allow more patients to benefit from Guardant’s industry-leading Shield blood test for early cancer detection through PathGroup’s large network of EMR hospital integrations and phlebotomists. More than five million patients each year receive testing through PathGroup.

Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended June 30, 2025.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Octave Bioscience, Inc., a commercial stage precision care company that is pioneering a new standard for managing multiple sclerosis (MS) and other neurodegenerative diseases, today announces the close of its $35.6 million Series C equity financing and that it has entered into a $15.5 million non-dilutive term loan agreement with Silicon Valley Bank (SVB) a Division of First Citizens Bank.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE IVDR approval for two label expansions for its VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* assay. HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.

The Board of Directors of bioMérieux, a world leader in the field of in vitro diagnostics, met on September 3, under the chairmanship of Alexandre Mérieux and approved the consolidated financial statements for the six months ended June 30, 2025.