FDA to review Roche's COBAS HIV test:
This article was originally published in Clinica
Roche Molecular Systems says that the US FDA has agreed to review the company's PMA supplement for its Cobas Amplicor HIV-1 Monitor test (version 1.5). The automated, PCR-based test can measure levels of HIV-1 RNA down to as few as 50 copies/mL of plasma. The test was designed to address the growing need to identify variations in the group M subtypes of HIV-1 RNA. The Pleasanton, California company CE-marked the device for sale in Europe in 1999.