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FDA Approves Roche's HIV-1 Viral Load Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Roche's Cobas HIV-1 viral load test, the company announced today.

The test runs on the Roche Cobas 6800 and 8800 platforms. It uses a dual-target technology to amplify and detect two separate regions of the HIV-1 genome not subject to selective pressure. The fully-automated Cobas systems provide up to 96 results in less than 3.5 hours, with a total number of results in an eight-hour shift of 384 for the 6800 system, and 960 for the 8800 system, Roche said in a statement.

Roche also has FDA-approved viral load tests for hepatitis B and hepatitis C on the 6800 and 8800 systems, and menu expansion plans include a viral load test for cytomegalovirus, as well as qualitative tests for women's health, microbiology, and donor screening.