FDA Clears HIV Test That Gives Results in 3 Minutes

By Ori Twersky

Canada's MedMira Inc. said on Thursday that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its 3-minute Reveal Rapid HIV-1 Antibody test.

Rival firm OraSure Technologies Inc. of Bethlehem, Pennsylvania recently won clearance for a 20-minute rapid HIV antibody test. But according to MedMira, the Reveal test has now become the fastest antibody test for HIV-1 to be cleared by the FDA.

The company said the test also has the longest shelf life of the rapid HIV tests available in the U.S., with a 1-year expiration date at room temperature.

The test has been shown to be equivalent to or better than conventional HIV diagnostic tests that typically take days to conduct, the firm added.

MedMira said healthcare products wholesaler Cardinal Health would be the exclusive distributor for the U.S. market.

Based on federal figures, about 8,000 patients a year who are tested for HIV at public clinics never return to get the results. Rapid HIV tests, which don't require a second visit for the client to get results, are expected to help combat that problem.

Earlier this month, MedMira received clearance to market its test in the People's Republic of China. The test is also cleared for sale in about 60 other countries, including Canada and Russia.

A marketing application for the test is pending in Europe.

04/18/03