www.fdanews.com/articles/177061-vela-diagnostics-earns-ce-mark-for-sentosa-assay
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Vela Diagnostics Earns CE Mark for Sentosa Assay
June 14, 2016
Singapore-based Vela Diagnostics has nabbed CE marking for its Sentosa SQ HCV Genotyping assay for in vitro diagnostic purposes, the company announced Tuesday.
The NGS-based assay is indicated for genotyping in patients diagnosed with HCV infection from human plasma or serum sample.
The test is the first commercially available NGS assay to be approved for high-risk blood disease. — Anisa Jibrell