The researchers found that Cepheid's Xpert HCV viral load assay used at the point of care performed at levels comparable to a laboratory test.
An OpenArray panel designed to simultaneously test for 17 viruses and 13 bacteria and protozoa was able to detect pathogens from human blood donor samples with an accuracy of about 95 percent.
Despite highly effective HCV drugs, testing for resistance mutations is important to prevent the spread of resistant strains and to tailor treatment.
The firm said the assay provides flexible automation and accurately identifies all six HCV genotypes as well as subtypes 1a and 1b.
Hologic said that HCV therapeutic options are evolving rapidly, and the approval will enable physicians to quickly decide on the best treatments.
The test is performed in less than an hour using a buccal cheek swab, and runs on Genedrive’s hand-held real-time PCR instrument.
A German clinical lab found that the test, run on Hologic's Panther system, was slightly more sensitive than a Roche assay on the High Pure System.