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

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: 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 September 30, 2023.

Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa) and Sysmex Corporation (President: Kaoru Asano) today announced that they have entered into an agreement to expand their Contract Development and Manufacturing Organization (CDMO) partnership for Sysmex's Automated Immunoassay System HISCL™-Series to include the field of neurodegenerative diseases, following the discussion based on the Basic Agreement on Business Collaboration in the field of immunoassay signed in October 2023*.

Personalis, Inc., a leader in advanced genomics for precision oncology (Nasdaq: PSNL), and Tempus Labs, Inc., a leader in artificial intelligence and precision medicine, today announced a strategic collaboration to co-commercialize NeXT Personal® Dx, Personalis’ whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer. NeXT Personal Dx is a leap forward in tumor-informed approaches, setting the new standard in performance of MRD tests with unprecedented sensitivity and high specificity. The test was launched by Personalis in October of this year.

Thermo Fisher Scientific, Pfizer Canada, and Colorectal Cancer Canada have awarded a total of C$300,000 ($221,081) to two Canadian healthcare providers to study the use of next-generation sequencing-based testing in colorectal cancer care.

A total of 13 departments, including the National Health Commission (NHC) and the National Development and Reform Commission (NDRC) have jointly formulated an action-implementation plan for cancer prevention and control from 2023 to 2030.

Today GE HealthCare (Nasdaq: GEHC) announced the release of a new, all-in-one platform of artificial intelligence (AI) apps to support clinicians with breast cancer detection and improved workflow productivity called MyBreastAI Suite.

Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, and Scipher Medicine, a precision immunology company, today announced a multi-pronged collaboration designed to expand patient access to diagnostic services advancing precision medicine for rheumatoid arthritis (RA).

China's in vitro diagnosis began in the 1980s. In the past years, the Chinese IVD industry has been following the trend of national reform and opening up and has made great achievements in the world. At present, China's IVD has developed into a complete industrial chain from reagent instrument system to raw materials and from the domestic market to the global market. Its products have covered all the subdivided fields of the industry and become one of the countries with the most complete product lines of IVD industry in the world.

Revvity said on Monday it has received a CE-IVD mark for a molecular testing platform that can be used to screen newborns for spinal muscular atrophy and severe combined immunodeficiency.

Roche announced on Monday that its hepatitis B immunoassay has received CE marking and is available for use in countries accepting the regulatory designation.