NEW YORK (GenomeWeb) – Genedrive announced today that its Genedrive HCV ID kit has achieved CE certification under the EU Medical Devices Directive. Genedrive's product functions as a qualitative molecular assay for hepatitis C.
According to Genedrive, the HCV assay runs on the company's Genedrive instrument, a PCR thermocycling device that provides rapid nucleic acid amplification and detection results. The assay does not require a separate viral RNA extraction process; instead, it is performed directly via a small, 25 microliter plasma sample. Using lyophilized PCR reagents packaged into a single-use, disposable cartridge, the assay delivers clinical results within 90 minutes.
"The combination of national screening programs, the availability of cost-effective treatment, and consequently a growing demand for molecular diagnostics is an area we can contribute to in a meaningful way," Genedrive CEO David Budd said in a statement.
Performance evaluation studies to support the assay's CE marking demonstrated sensitivity and specificity fulfilling requirements published by the Foundation for Innovation in New Diagnostics, Genedrive said.
Late last year, Genedrive received CE-IVD approval for its IL28B SNP human genotyping test, clearing it for sale in Europe.