FDA approves Cobas 6800 + 8800 HIV test for viral load diagnostics- Roche

Roche has received approval for the cobas HIV-1 viral load test by the FDA for use on the cobas 6800 and cobas 8800 Systems. The cobas HIV-1 test is built upon the dual-target assay design from Roche. The test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, allowing for more reliable results to confidently and effectively quantify the amount of HIV-1 RNA in a patient's blood.

In addition to the new HIV-1 assay, Roche offers the FDA-approved cobas HBV and cobas HCV viral load tests on the cobas 6800/8800 Systems. The fully automated systems offer fast time to results, high throughput and long walk-away time available among automated molecular platforms, providing efficiency and flexibility. Further menu expansion plans include a viral load test for cytomegalovirus (CMV) and qualitative tests for donor screening, women's health and microbiology.