FDA Approval Announced for Innovative HIV Viral Load Test

Roche Molecular Diagnostics has announced that its new HIV viral load test has been approved by the United States Food and Drug Administration (FDA) and will be commercially available in the US later this year.

According to the Centers for Disease Control and Prevention (CDC), an estimated 1.2 million persons were living with HIV infection in the United States at the end of 2010. Of those, 20% had undiagnosed HIV infections. Highly active antiretroviral treatment (HAART) and viral load tests that determine the amount of circulating HIV have contributed to a profound increase in life expectancy for people living with HIV.

The COBAS^® TaqMan® HIV-1 Test, v2.0 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.

Roche’s dual-target approach for HIV viral load testing ensures enhanced reliability of results and increased confidence in assessing viral loads even in the face of the rapidly growing genetic diversity of HIV-1. This approach targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing reliable test results even with rare mismatches in primer/probe binding sites and when mutations are present. Since Roche first introduced this innovative dual-target approach for monitoring HIV-1 patients on antiretroviral therapy in 2008, over eight million tests have been performed worldwide on Roche fully automated real-time PCR platforms.

“The approval of the Roche HIV test expands the availability to more laboratories, clinicians and patients,” said Paul Brown, PhD, Head of Roche Molecular Diagnostics. “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.”