From January 2024 and June 2025, the U.S. Food and Drug Administration (FDA) approved 39 in-vitro toxicology testing products through the 510(k). This period marked a significant reshaping of the global market: Chinese companies, driven by rapid product iteration and precise market positioning, surged in the market share. At the same time, the worsening fentanyl crisis in the U.S. fueled an unprecedented demand for fentanyl testing, making it the most competitive and dynamic segment in the field.

Conventional thrombosis and hemostasis diagnostic applications are mainly concentrated on screening for bleeding disorders and diagnosis of bleeding origins, with a relatively narrow scope of application and relatively poor accuracy.

Wolfe Research said Thursday that it has upgraded Danaher's shares to an Outperform rating from Peer Perform as the firm's growth is improving and it has capital to deploy.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2024.

bioMérieux, a world leader in the field of in vitro diagnostics, today releases its business review for the nine months ended September 30, 2024.

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, 2024.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Mini test for clinical use. It is the third test to receive FDA clearance for use with QIAstat-Dx systems in 2024.

The US Administration for Strategic Response and Preparedness' Biomedical Advanced Research and Development Authority (BARDA) announced Monday that it has awarded a $9.2 million contract to Revvity to develop a home-use test for the detection of SARS-CoV-2 and influenza A and B.

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.

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

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.