Roche receives FDA approval for HIV-1/HIV-2 diagnostic test

Sept. 1, 2020

Roche announced U.S. Food and Drug Administration (FDA) approval for the cobas HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas 6800/8800 Systems in the U.S., which will provide a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options.

Studies show that 50 percent of new HIV infections may be transmitted during the acute period, between three days and three weeks from the time of infection. Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate.

The higher sensitivity of PCR technology, which is used with the cobas HIV-1/HIV-2 Qualitative Test, can reduce this time-to-detection period by one week or more. This significant reduction in time to detection is critical to improve personalized healthcare while curbing further disease transmission.

Roche has the release.

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