FDA Approves Alere's Moderate Complexity Rapid Diagnostic Test for HIV-1 and HIV-2

by Winny Tan 18 Sep 2013
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Source: Alere Press Release; August 9, 2013

Alere announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its DetermineTM HIV-1 and HIV-2 Ag/Ab Combo rapid diagnostic test. The company reports that this is the first FDA approved point-of-care test (POCT) that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen with a moderate complexity designation.  

Alere leads in the global POCT market with 40% market share. The company earns more than $2 billion annually with products that span all POCT segments including blood glucose/Hb1AC, cholesterol, coagulation, cardiac biomarkers, urinalysis, drugs-of-abuse, infectious disease, pregnancy, hematology, and fecal occult. Alere is fulfilling its strategic focus in the high growth infectious disease POCT segment that is growing more than 7% in the United States. Strong market drivers globally such as the HIV infection population screening recommended by the U.S. Preventative Services Task Force, growing prevalence of sexually transmitted disease in Western Europe, high demand in the emerging market India and China, and laboratory decentralization; indicate that Alere’s accurate yet easy-to-use HIV test will find success in several regions.

This announcement also marks a milestone for the POCT industry that is moving towards Clinical Laboratory Improvement Amendments (CLIA)-waived POCT molecular testing which the industry expects to arrive within the next 3 years. While Alere’s moderate complexity test is an improvement over traditional HIV immunoassay laboratory tests that lack speed, the ultimate goal for rapid testing will be to achieve a CLIA-waived POCT molecular test for HIV in which speed can be attained without sacrificing accuracy. Indeed, the company plans to complete and submit the CLIA waiver trial data by 2014.

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