The US Food and Drug Administration (FDA) has approved Alere's pre-market application (PMA) for the commercialization of Alere Determine HIV 1/2 Ag/Ab Combo in the country.
The FDA approval allows the marketing of Alere Determine HIV 1/2 Ag/Ab Combo as a Clinical Laboratory Improvement Amendments moderately complex medical device.
The only FDA-approved rapid point-of-care test detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.
Alere infectious disease global president Avi Pelossof said the company's next step is to complete the CLIA waiver trials with the intention to submit the data in late 2013 or early 2014.
"The Alere Determine Combo can help to identify additional cases that would not be detected using second and third generation antibody-only tests," Pelossof added.
"We anticipate Alere Determine Combo to play a critical role in the U.S. to help identify individuals with HIV and to help break the infection cycle."
