RE: Genedrive® CYP2C19 ID. CE IVD approval is excellent news. 31 more30 May 2025 15:45
NEW YORK — Genedrive said Friday that it has received CE marking under the EU's In Vitro Diagnostic Medical Device Regulation (IVDR) for its point-of-care CYP2C19 ID Kit genotyping platform, which is used to guide therapy selection in stroke patients.
Clopidogrel — sold under the brand names Plavix, Iscover, and others — is often administered to patients with ischemic stroke or transient ischemic attack to prevent an additional stroke. The CYP2C19 gene encodes a protein that is necessary to metabolize the drug, but some patients carry variants of the gene that render clopidogrel less effective. If a patient is identified as a carrier of such variants, a different antiplatelet therapy might be prescribed.
Genedrive said its kit identifies five of these DNA variants, including ones important in certain ethnicities. It received UK Conformity Assessed (UKCA) marking registration in late 2023.
"Whilst UKCA certification enabled a focus on national commercialization routes [in the UK] … we have also focused efforts on defining market access routes in specific European countries which CE-certification now permits and in non-European countries in which it facilitates registrations," Genedrive CEO Gino Miele said in a statement.
https://www.genomeweb.com/business-news/genedrive-gets-ce-ivdr-mark-pgx-test-stroke-patients?utm_term=Autofeed&utm_medium=Social&utm_source=LinkedIn#Echobox=1748614722
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