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Roche’s HIV-1 viral load test wins FDA approval for use on cobas 6800/8800 systems

MDBR Staff Writer Published 22 December 2015

Switzerland’s Roche has obtained approval from the US Food and Drug Administration (FDA) for its cobas HIV-1 viral load test to be used on the cobas 6800 and cobas 8800 systems.

Roche

Part of the firm's next-generation viral load tests, the HIV-1 viral load test enables clinicians to manage the disease and treatment of patients infected with HIV-1.

The test simultaneously magnifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, providing enhanced results to effectively quantify the amount of HIV-1 RNA in a patient's blood.

Roche Molecular Diagnostics head Paul Brown said: "The cobas HIV-1 test is based on Roche's unique dual-target technology to simultaneously amplify and detect two separate regions of the HIV-1 genome, which are not subject to selective drug pressure.

"The addition of this test on the fully automated cobas 6800/8800 Systems provides laboratories with a comprehensive virology menu to support physicians in making informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy."

The company also provides FDA-approved cobas HBV and cobas HCV viral load tests, which can be used on the cobas 6800/8800 systems.

The cobas 6800/8800 systems are fully integrated and automated solutions, which are developed to enhance routine molecular testing in the areas of donor screening, viral load monitoring, women's health and microbiology.

Based on PCR technology, the systems offer up to 96 results in less than 3.5 hours, while a total of 384 results for the cobas 6800 system and 960 results for the cobas 8800 system in an eight-hour shift.

In November this year, Roche received FDA approval for its cobas epidermal growth factor receptor (EGFR) mutation test v2 as a companion diagnostic for non-small cell lung cancer (NSCLC) therapies.


Image: The administration and R&D buildings, Roche Diagnostics, Rotkreuz. Photo: courtesy of F. Hoffmann-La Roche Ltd.