OraSure Receives CLIA Waiver for OraQuick Rapid HIV-1 Antibody Test
BUSINESS WIRE
January 31,
2003
BETHLEHEM, Pa.--(BUSINESS WIRE)--Jan. 31, 2003--OraSure Technologies, Inc., the market leader in oral fluid diagnostics, announced today that the U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health, has approved a waiver under the Clinical Laboratory Improvements Amendments of 1988 (CLIA) for the Company's OraQuick® Rapid HIV-1 Antibody Test. This waiver was granted on the basis of information contained in the Company's application received by the FDA on January 30, 2003. With this waiver, the OraQuick® test, which provides HIV-1 test results in just 20 minutes, can now be used by a larger number of sites in the United States, including outreach clinics, community-based organizations and physicians' offices.
"We are very excited about the CLIA waiver and the opportunity to make the OraQuick® test available to all who need it," said Mike Gausling, Chief Executive Officer of OraSure Technologies. "This waiver is the result of a comprehensive and exhaustive review by the FDA following their initial approval of OraQuick® last year. The agency's continued cooperation and collaboration with OraSure on this product is very much appreciated."
On November 7, 2002, the Company received FDA approval to manufacture and market the OraQuick® test in the United States for the detection of HIV-1 antibodies in finger-stick whole blood samples.
Under that initial approval, the test was categorized as moderately complex and was restricted to use only in the nearly 40,000 laboratories in the United States certified under CLIA to perform moderately complex diagnostic tests. At the time of the initial approval, United States Health and Human Services Secretary, Tommy G. Thompson, strongly urged OraSure to submit an application for a CLIA waiver in order to expand the potential use of the test.
The OraQuick®
test has a sensitivity of 99.6% and specificity of 100% based on clinical
studies performed by OraSure in support of its FDA approval. Sensitivity is a
measure of the accuracy for detecting positive specimens, and specificity is a
measure of the accuracy for identifying negative specimens.