Alere Determine HIV-1/2 Ag/Ab Combo test regulatory update

FDA approved a PMA from Alere for Alere Determine HIV-1/2 Ag/Ab Combo test as an aid in the diagnosis of HIV-1 and HIV-2 infection. The agency said Alere Determine is the first test that simultaneously detects HIV p24 antigen and antibodies to HIV-1 and HIV-2 in serum, plasma and venous or fingerstick whole blood specimens. The approval allows Alere to market the test as a CLIA moderately complex medical device. Alere plans to complete CLIA waiver trials and submit the data in late 2013 or early 2014. ...