Roche Dual-PCR Target HIV-1 Test Receives FDA Clearance

Roche Molecular Diagnostics has received FDA approval for its new dual-PCR target HIV-1 viral load test to quantify the amount of virus in a patient's blood.

The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 is the quantitative viral load test to amplify and detect two separate regions of a target genome and offers a fully automated and reliable solution for physicians to make informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy.

The company said that highly active antiretroviral treatment (HAART) and viral load tests, which are used to monitor the amount of human immunodeficiency virus (HIV) circulating in blood, have contributed to a 13-year increase in life expectancy for people infected with HIV.

Paul Brown, president and CEO of Roche Molecular Diagnostics, said: “With the introduction of this test, Roche is the only company in the world to offer a dual-PCR target quantitative viral load assay. By virtue of its design, the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 can improve the ability of physicians and laboratories to obtain reliable information about HIV-infected patients in order to make informed treatment decisions.”

Tri Do, director for clinical research and scientific affairs at Roche Molecular Diagnostics, and an HIV-treating physician, said: “Treatment of HIV patients with new anti-viral therapies, such as integrase inhibitors, has met with success, but can also introduce selective pressures that result in changes to the HIV genome, which could make it harder to detect and treat. Roche’s new dual-PCR target HIV-1 viral load test is designed to detect current and emerging genomic variants of HIV with increased sensitivity.”