Chembio forms agreements, waits for CLIA waiver for rapid HIV test kits

By Lisa Kerner

Charlotte, N.C., Oct. 10 - Chembio Diagnostics, Inc. chairman and chief executive officer Larry Siebert said he does not know just how big the rapid HIV testing market will become but he said he is sure "there is room for us."

"Whether the market becomes a $50 million or a $100 million market in the next few years, I don't know," Siebert said during a company update Tuesday.

Siebert reviewed Chembio's recent agreements with Inverness Medical Innovations and StatSure Diagnostic Systems, Inc. to market rapid HIV and other tests in the United States.

The agreements cover Chembio's rapid test for the detection of antibodies to HIV that uses Inverness' proprietary lateral flow technology and StatSure's patented "barrel" technology designed for ease of use.

One of Chembio's main goals now is to obtain a clear Clinical Laboratory Improvement Amendment (CLIA) waiver from the Food and Drug Administration for its Sure Check HIV 1/ 2 rapid diagnostic test.

According to Siebert, there are "no material obstacles" to the waiver, but he did not provide additional details.

The company also just completed a private placement totaling $8.15 million of series C preferred stock, proceeds of which will allow Chembio to fund clinical trials, growth initiatives and marketing.

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

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