FDA approves cobas HIV-1/HIV-2 Qualitative Test for HIV diagnosis.- Roche

Roche announced that 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. The test provides healthcare professionals with 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% 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 personalised healthcare while curbing further disease transmission.