Alere Inc (ALR)

[mlkrborn]

Alere confirms FDA Approval for Alere Determine HIV-1/2 Ag/Ab Combo (ALR) 31.56 +0.27 : Co confirmed 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[1],[2] HIV-1/2 antibodies.