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OraSure Technologies applies for FDA approval
to expand use of rapid Hepatitis C test
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Published: Wednesday, March 23, 2011, 2:21 PM Updated: Wednesday, March 23, 2011, 3:16 PM
Tom Zanki | Lehigh The Express-Times By Tom Zanki | The Express-Times
OraSure Technologies Inc. is requesting federal regulators approve its rapid Hepatitis C test for wider use.
Shares rose after the announcement.
The Bethlehem diagnostics company said today it has applied for a waiver with the Food and Drug Administration that would allow distribution of the test at clinics, doctor's offices and community organizations.
Currently the test, marketed under the company's OraQuick brand, is sold only to laboratories.
Known as a CLIA waiver - after the Clinical Laboratory Improvement Amendments of 1988 - Orasure says approval would enable the company to sell the test to an additional 180,000 sites.
"Most importantly, the CLIA waiver will enable health care providers, those on the front lines of the disease, to identify more individuals infected with Hepatitis C and connect them to care and treatment," OraSure CEO Doug Michels said in a statement today.
Hepatitis C is a virus that causes hepatitis, or inflammation of the liver. OraSure's rapid test can detect the virus using a fingerstick or whole blood samples.
The company did not indicate a time frame by when it expects FDA response.
Shares rose 38 cents, or 5.4 percent, to $7.38 in afternoon trading on the Nasdaq.
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