HCV

An RNA test in development that confirms whether a patient has HCV within 40 minutes could enable diagnosis and prescribing treatment during a single office visit.

At least one HIV self-test from a competitor could reach the global market this year. In addition, the company is in the midst of a strategic review.

The company said the disposal of these two businesses is part of a strategy to focus entirely on the molecular diagnostics market.

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.

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