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BETHLEHEM, Pa. (Dow Jones)--OraSure Technologies Inc. (OSUR) applied to the Food and Drug Administration for a waiver for its OraQuick Rapid HIV-1 Antibody Test, which would allow the test to be used at certain sites in the U.S. including outreach clinics and physicians offices.
In a press release Friday, the company said with an approved CLIA, or Clinical Laboratory Improvements Amendment, waiver the OraQuick test, which provides HIV-1 test results in 20 minutes, would be available for use by sites in the U.S. that are CLIA-waived.
On Nov. 7, OraSure received FDA approval to make and market the OraQuick test in the U.S. for the detection of HIV-1 antibodies in finger-stick whole blood samples.
But, because the test is categorized as moderately complex, it is restricted for use only in the nearly 40,000 laboratories in the U.S. certified under CLIA to perform moderately complex diagnostics tests.
U.S. Health and Human Services Secretary, Tommy G. Thompson, urged OraSure to submit an application for a CLIA waiver in order to expand the potential use of the test, the company said.
The company's shares closed Thursday at $6.20, down 10 cents, or 1.6%, in Nasdaq trading.
-Jenny Park; Dow Jones Newswires; 201-938-5400

(END) Dow Jones Newswires
01-31-03 0732ET