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GEN News Highlights : Jul 2, 2012

FDA Approves Roche's HIV Test

COBAS TaqMan HIV-1 Test, v2.0 uses a dual-target approach to increase reliability.

Roche’s COBAS® TaqMan® HIV-1 Test, v2.0, has been approved by the FDA. The test will be commercially available in the U.S. later this year.

This HIV viral-load test targets two highly conserved regions of the HIV-1 genome and avoids any regions that are current drug targets. Roche says that this approach provides increased reliability as compared to other single-target assays should a mutation occur.

“The approval of the Roche HIV test expands the availability to more laboratories, clinicians, and patients,” says Paul Brown, Ph.D., head of Roche Molecular Diagnostics. “Roche is committed to developing new diagnostic tools such as this HIV ‘dual target’ test to help improve the ability of physicians to monitor viral load and properly treat 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.