www.fdanews.com/articles/174611-roche-scores-fda-approval-for-hiv-1-viral-load-test
Roche Scores FDA Approval for HIV-1 Viral Load Test
December 21, 2015
The FDA has given its blessing to Roche’s cobas HIV-1 viral load test for use on the cobas 6800 and cobas 8800 systems.
Clinicians will use the test – along with other next generation viral load tests – to manage and treat patients infected with HIV-1.
The test works by simultaneously amplifying and detecting two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, says Paul Brown, head of Roche Molecular Diagnostics. — Michael Cipriano