Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China. Latest news
According to the statistics published on the website of the NMPA, in 2020, NMPA approved eight models, one is for fluorescent PCR data analysis, one is for chip data analysis, five are for sequencing data analysis, and one is for interpretation of tumor and genetic disease gene detection results.
Eurofins Scientific (EUFI.PA), a global scientific leader in bioanalytical testing, with a rapidly developing presence in highly specialised and molecular clinical diagnostics testing and in-vitro diagnostic products, has reached an agreement with SYNLAB to acquire its clinical diagnostics operations in Spain. The transaction is subject to customary conditions, including regulatory approvals, and is expected to close in 2025.
Devyser has achieved a significant regulatory milestone with its first market registration from China’s National Medical Products Administration (NMPA) for Devyser Compact, an IVDR-certified genetic test for detecting fetal chromosomal abnormalities. Rapid prenatal aneuploidy detection kits fall under Class III IVD as part of the NMPA product registration process. This approval enables Devyser to market Devyser Compact as an in vitro diagnostic in China and paves the way for future regulatory approvals in the region for its simple, fast, and accurate genetic testing solutions.
LabGenomics USA has successfully acquired Integrated Molecular Diagnostics (IMD) CLIA labs, bringing the total number of its CLIA-certified labs in the U.S. to four. This acquisition strengthens LabGenomics’ strategic development and expands its diagnostic services nationwide, particularly in molecular technology.
Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced the acquisition of EpiCapture Limited, a company developing a non-invasive test for monitoring the risk of aggressive prostate cancer. This acquisition marks Trinity Biotech’s strategic expansion into the oncology diagnostics market.
Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced results for the third quarter ended September 30, 2024 and updated full-year guidance.
SCIEX, a global leader in life science analytical technologies, and Bioinformatics Solutions Inc. (BSI), provider of next-generation, deep learning proteomics and AI-driven biotechnology solutions, advance their collaboration with the co-development of PEAKS 12.5. This new software launch is fully compatible with the ZenoTOF 7600+ system, offering exclusive commercial support of ZT Scan DIA for proteomics applications.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the third quarter ended September 28, 2024.
Group sales grew by 6% at constant exchange rates (CER) (2% in CHF) in the first nine months, driven by the high demand for both our medicines and diagnostics; excluding COVID-19-related products, sales increased by 8%
Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, today announced financial results for the third quarter ended September 30, 2024.
Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the quarter ended September 27, 2024. All results in this release reflect only continuing operations unless otherwise noted.
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