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Cepheid Fingerstick HCV Test Receives CE-IVD Clearance

NEW YORK (GenomeWeb) – Cepheid announced today it has received CE-IVD marking on a fingerstick test that can be used to quantify viral loads of hepatitis C virus. The test is now available in the EU and countries recognizing the CE mark.

The test, called Xpert HCV VL Fingerstick, detects RNA levels of HCV directly from blood and can be used in near-patient settings, potentially obviating the need for centralized testing and preventing loss to follow up. It detects a wide range of HCV genotypes in about one hour, such that diagnosis and initiation of antiviral treatment might occur within a single clinic visit, the firm said in a statement.

"This is the first HCV RNA detection technology sensitive enough for both active case finding and use as a potential test of cure at the point of care," said David Persing, Cepheid's chief medical and technology officer.

The fingerstick HCV test has been evaluated by researchers in Australia in a study published last year, and was also found in a subsequent study to have 100 percent sensitivity and specificity compared to a gold standard test, the Abbott RealTime HCV Viral Load assay.

The test was developed by Cepheid along with collaborators at the Kirby Institute in Australia and the Foundation for Innovative New Diagnostics. Earlier this year FIND awarded grants to six firms developing HCV diagnostics, three of which were for point-of-care molecular assays. Other notable near-patient and point-of-care HCV tests in development includes ones from Genedrive and Johns Hopkins.