The following innovative products have obtained the registration certificate of regulatory authorities for the first time in the industry based on the technology platform, and are open to the whole market as the benchmark. Only some representative products are listed.
Yourgene Health (part of the Novacyt group of companies), a leading international molecular diagnostics group, announces that it has received accreditation under the new EU requirements of the in vitro diagnostic regulation (IVDR) for the Yourgene® Cystic Fibrosis Base assay. The Yourgene Cystic Fibrosis Base assay is a Class C in vitro medical device under IVDR and is intended for use by healthcare professionals within a molecular laboratory environment.
Agilent Technologies Inc. (NYSE: A) today announced the company has completed its acquisition of BIOVECTRA, a Canada-based contract development and manufacturing organization (CDMO) that specializes in biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics.
Switzerland's Saphetor said Wednesday that it has received CE marking for VarSome Clinical, its genome interpretation platform.
Genetron Holdings Limited (“Genetron Health” or the “Company”, Nasdaq: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, announced today the completion of its merger (the “Merger”) with Genetron New Co Limited (“Merger Sub”), pursuant to the previously announced agreement and plan of merger, dated as of October 11, 2023 (the “Merger Agreement”), among the Company, New Genetron Holding Limited (“Parent”) and Merger Sub. As a result of the Merger, the Company has become a wholly owned subsidiary of Parent and will cease to be a publicly traded company.
Cepheid announced that it has received the CE mark for Xpert NPM1 Mutation, a molecular in vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from patients with Acute Myeloid Leukemia (AML).
DiaSorin said late Friday that it has nabbed US Food and Drug Administration 510(k) clearance for a molecular assay that differentiates between infections with the SARS-CoV-2 and influenza A and B viruses.
BioMérieux reported Wednesday that its fourth quarter revenues rose 11 percent year over year.
Shanghai Rigen Biotech Co., Ltd. (hereinafter referred to as "Rigen") recently completed a new round of financing of nearly 100 million CNY.
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