Alere Obtains FDA Approval For Alere Determine HIV-1/2 Ag/Ab Combo

(RTTNews) - Alere Inc. (ALR) announced Friday that it has received U.S. Food and Drug Administration or FDA approval of its pre-market application or 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.

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."