FDA approves Roche HIV viral load test

The COBAS TaqMan HIV-1 Test, v2.0, targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, according to the company.

Roche Molecular Diagnostics head Paul Brown said the approval of the Roche HIV test expands the availability to more laboratories, clinicians and patients.

"Roche is committed to developing new diagnostic tools such as this highly innovative HIV ‘dual target’ test to help improve the ability of physicians to monitor viral load and properly treat people living with HIV," Brown added.

The new test utilizes the FDA-approved High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 Analyzer for automated amplification and detection.