Chembio 'approvable' on HIV rapid test

MEDFORD, N.Y., April 19 (UPI) -- Chembio said Wednesday it has received an "approvable" letter from the Food and Drug Administration for its rapid HIV tests.

The letter told the company that it must first resolve issues relating to the product's package inserts before Chembio's Sure Check HIV 1/2 and HIV 1/2 Stat-Pak can hit the market.


The company said it anticipates ultimately marketing its rapid test -- which detects HIV antibodies in 15 minutes -- in retail drugstores.

For now, Chembio said it would sell the product to hospitals and clinics after securing final FDA approval. The company added it is currently in talks with a potential marketing partner, which would sell the test exclusively in the United States if a deal is struck.

The company said its new rapid test detects HIV-1 and HIV-2 antibodies in four types of test samples: finger-stick whole blood, venous whole blood, serum and plasma.

"Estimates are that as much as 1/3 of those infected with HIV in the US population are not aware of their HIV-positive status. We believe that these individuals are much likelier to access testing services if test results and counseling can be delivered at the point of care, rather than having to wait days or weeks for laboratory results," said Chembio President and Chief Executive Officer Lawrence Siebert.


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