Alere Inc. (NYSE: ALR), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health information, announced today that it has received U.S. Food and Drug Administration (FDA) approval of its pre-market application (PMA) to market Alere Determine™ HIV 1/2 Ag/Ab Combo in the United States for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2. The FDA approval allows Alere to market Alere Determine™ HIV 1/2 Ag/Ab Combo as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device.
Alere Determine™ HIV-1/2 Ag/Ab Combo is the first and only FDA-approved rapid point-of-care test that 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.
According to the Centers of Disease Control and Prevention (CDC), there are 1.4 million Americans living with HIV, and approximately 207,000 (18%) whose infections have not been diagnosed. In 2010, the CDC estimated that there were 47,500 newly infected people with the virus in the United States, indicating that HIV remains a serious health problem. HIV testing is essential for healthcare and social services to improve the quality of life and survival for persons who have HIV. Individuals who are acutely infected with HIV, which is defined as the interval between the appearance of HIV RNA in plasma and the detection of HIV-1 specific antibodies, contribute disproportionately to HIV transmission. With the use of the Alere Determine™ HIV 1/2 Ag/Ab Combo, HIV can be detected earlier than second and third generation antibody-only tests.
Avi Pelossof, Alere Global President of Infectious Disease, said, "We are pleased that the FDA has issued the approval for Alere Determine™ HIV 1/2 Ag/Ab Combo. Our next step is to complete the CLIA waiver trials with the intention to submit the data in late 2013 or early 2014."
Pelossof added, "The Alere Determine™ Combo can help to identify additional cases that would not be detected using second and third generation antibody-only tests. 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."