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Will Fast Hepatitis C Diagnostic Test Meet FDA Approval?

July 23, 2007

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On Thursday, July 19th, OraSure Technologies announced the positive performance of a rapid test that can detect the Hepatitis C virus in blood and saliva in just minutes. Learn when the company plans to finalize its clinical studies and file an application for U.S. FDA approval.

OraSure's hepatitis test on target

Company says its prototype performed well in trial.

By Sam Kennedy | Of The Morning Call
July 20, 2007

www.mcall.com

A hepatitis C test under development by OraSure Technologies of Bethlehem performed well in a recent trial, the company announced Thursday.

The news bodes well for OraSure's efforts to win governmental approval to sell a rapid hepatitis test that works similarly to the company's rapid HIV test. That test, called OraQuick, can detect the virus that causes AIDS in both saliva and blood in less than 20 minutes

Performance of the prototype hepatitis C test was shown to be as good as or better than that of currently available laboratory-based tests, the company said at the annual meeting of the American Association of Clinical Chemistry in San Diego.

''Our development efforts are proceeding on schedule, and we intend to begin the final clinical studies required to obtain FDA approval during the next several months,'' OraSure Chief Executive Doug Michels said in a press release.

He said OraSure plans to complete the studies and file an application for U.S. Food and Drug Administration approval in early 2008.

''Assuming we are successful, we expect that our test will be the first rapid [hepatitis C] test approved by the FDA for use in the United States,'' he said.

Hepatitis C kills as many as 10,000 Americans a year, a figure that is expected to double or triple in the next decade or so, surpassing annual AIDS deaths, according to the Centers for Disease Control and Prevention in Atlanta.

It is nonetheless known as a silent epidemic because infections often go undetected for years, even decades. The CDC estimates that 4.1 million people in this country, or nearly 2 percent of the population, have the disease, although fewer than half are aware of it.

The study described Thursday involved the testing of more than 1,000 blood and saliva specimens. According to OraSure, the prototype hepatitis C test performed with nearly 100 percent accuracy.

Posted by Editors at July 23, 2007 5:00 PM

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