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Chembio HIV test wins approval for wider use in US

Dhammika Gunasekera, director of research and development, left,

Dhammika Gunasekera, director of research and development, left, and scientist Kathleen Addiss prepare to encode DPP tests for HIV-syphilis blood samples on Oct. 24, 2014. Credit: Joseph D. Sullivan

Chembio Diagnostics Inc. said Thursday that distribution of one of its rapid HIV tests would be expanded to clinics, community health care centers and more doctors' offices in this country due to a federal waiver.

The Medford-based manufacturer of point-of-care tests for HIV and syphilis has received a waiver from the federal Food and Drug Administration under the Clinical Laboratory Improvement Amendments, a 1988 law requiring only easy-to-use tests be administered in doctors' offices.

The Chembio HIV test had previously been approved for use but on a more limited scale.

"Accurate diagnostic testing is an important tool in the battle against HIV/AIDS," said Chembio chief executive John J. Sperzel. "We recently signed agreements with several major U.S. distributors. With receipt of this latest waiver, we will expand our U.S. sales and marketing effort as planned."

Since joining Chembio earlier this year, Sperzel has built an in-house sales force and signed agreements with other companies to develop rapid tests for Ebola, dengue fever virus and an undisclosed type of cancer.

Thursday's announcement came before the stock market opening. In early trading, Chembio shares were up 19 cents, or 4 percent, to $4.56 on the Nasdaq.

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