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

NEW YORK The Japanese Ministry of Health, Labor, and Welfare has approved the MET Inhibitor tepotinib (Merck KGaAs Tepmetko) for non-small cell lung cancer patients with MET exon 15 skipping alterations, after the drug demonstrated meaningf

NEW YORK The US Food and Drug Administration on Friday warned consumers to watch out for companies marketing unproven products for diagnosing, preventing, or treating COVID-19. We will continue to aggressively pursue those who place the pub

NEW YORK While many in the US and Europe have only recently come to understand the scope and severity of the SARS-CoV-2 pandemic, a handful of proteomics labs have been studying the virus since the beginning of the year. These studies have

NEW YORK A new UK-based research consortium is betting that sequencing the virus that causes COVID-19 can provide policymakers with a clearer picture of the spread of the epidemic across the country as diagnostic testing remains limited. I

NEW YORK In a new study published in Nature on Wednesday, researchers in China described the cell type composition of all major human organs, based on the RNA sequences of more than 500,000 single cells from Chinese Han donors. Using single

NEW YORK Personalis reported after the close of the market on Wednesday that its fourth quarter revenues rose 38 percent year over year, driven by an increase in testing volume and analytical services provided to the US Department of Vetera

NEW YORK Oncocyte said after the close of the market on Wednesday that its fourth quarter net loss rose 77 percent year over year as it pushed toward a transition to commercial test operations. For the three-month period ended Dec. 31, 2019

NEW YORK Biocept said after the close of the market on Wednesday that its fourth quarter revenues more than doubled year over year, driven by 46 percent growth in commercial test volume and 34 percent growth in average insurance reimburseme

NEW YORK HTG Molecular Diagnostics reported after the close of the market on Wednesday an 11 percent year-over-year drop in its full-year revenues, driven by a significant decrease in collaboration revenue. For the year ended Dec. 31, 2019,

FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially redu