Alere's HIV Combo Test Gets CLIA Waiver from the FDA

Global rapid diagnostic tests company, Alere Inc. (ALR - Snapshot Report), recently announced that its Alere Determine HIV-1/2 Ag/Ab Combo test has been granted Clinical Laboratory Improvement Amendments (CLIA) Waiver by the U.S. Food and Drug Administration (FDA). The same was FDA-approved in Aug 2013 as the first fourth-generation, rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen.

Until now, the test had been available for sale in the U.S. to health facilities and laboratories licensed to conduct tests of moderate complexity. With the CLIA approval, the test will now be available for use in physician offices, clinics and other public health settings as well.

Shares of the Waltham, MA-based company rose 1.1% in the trading session after the news on Tuesday but pulled back to close the day lower at $37.86. One-year return of the stock stands at roughly 8.5%.

Alere’s fourth-generation Combo Test has the ability to independently distinguish results for HIV-1 p24 antigen and HIV antibodies in a single test. Owing to its ability to detect p24 antigen, which usually appears 12-26 days after the infection is contracted and before the HIV antibody is detectable, Alere Determine HIV-1/2 Ag/Ab Combo allows early detection of the HIV infection.

Early detection provides significant advantage in the fight against HIV/AIDS. It allows healthcare providers to improve clinical outcomes through earlier diagnosis and treatment of patients who test positive for HIV. Earlier diagnosis further helps reduce additional HIV transmission.

With the CLIA Waiver, Alere’s HIV test will be available for broader use in HIV screening. A wider availability of the test in laboratories, physician offices, clinics and other public health settings will facilitate accurate and early detection of HIV, which in turn will help limit the spread of HIV/AIDS in the U.S. - See more at:

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