The US Food and Drug Administration (FDA) has approved Roche's new COBAS TaqMan HIV-1 viral load test.
The HIV viral load 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.
The test, based on dual-target approach, targets two conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing test results even with rare mismatches in primer/probe binding sites and when mutations are present.
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.
