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

21 December 2015 (Last Updated December 21st, 2015 18:30)

The Food and Drug Administration (FDA) has granted approval for Swiss global healthcare firm Roche's cobas HIV-1 viral load test to be used on the cobas 6800 and cobas 8800 systems.

Roche

The Food and Drug Administration (FDA) has granted approval for Swiss global healthcare firm Roche's cobas HIV-1 viral load test to be used on the cobas 6800 and cobas 8800 systems.

Developed as part of the company's next-generation viral load tests, the HIV-1 viral load test allows clinicians to manage the disease and treatment of patients infected with HIV-1.

Built upon the company's dual-target assay design, the cobas HIV-1 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 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."

Apart from the new HIV-1 assay, 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 improve routine molecular testing in the areas of donor screening, viral load monitoring, women's health and microbiology.

The systems, which are based on PCR technology, 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.

As of 2014, there were 37 million people living with HIV around the world, according to the World Health Organisation (WHO).


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