Chembio seeks approval to market HIV test in medical offices

By Elaine Rigoli

Tampa, Fla., July 12 - Chembio Diagnostics, Inc. has submitted a CLIA waiver application for the Chembio HIV 1/ 2 Stat-Pak rapid diagnostic test. If granted, it will allow Chembio to market to about 189,000 laboratory entities across the United States, including doctors' offices and clinics.

Chembio received marketing approval for its HIV test from the Food and Drug Administration's Center for Biologics and Research on May 25.That approval is a prerequisite to submitting the CLIA waiver.

The test is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2.

"In view of new recommendations by the United States Centers for Disease Control that HIV tests become a part of routine medical care for most Americans, the CLIA waiver, once it is granted, would enable Chembio to provide its tests to doctors' offices and clinics, where much of this testing would be taking place," chief executive officer Larry Siebert said in the release.

Chembio develops rapid diagnostic tests for infectious diseases and is based in Medford, N.Y.

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