HCV

The company's HIV testing revenues were up 24 percent year over year, while HCV testing revenues plummeted 68 percent.

The agency updated its guidance for samples tested using nucleic acid testing, saying the technology has improved detection for the viruses.

The device is expected to be used with Genedrive's hepatitis C virus assay, which recently received CE-IVD marking.

The alliance follows a marketing deal signed with Sysmex Europe that covers Europe, the Middle East, and Africa.

The two companies plan to secure required initial regulatory approvals in individual African territories before expanding to other areas in the region.

The British-based firm says that its assay detects hepatitis C via a single-use, disposable cartridge within 90 minutes of testing. 

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.

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