• http://www.reuters.com/article/idUSSGE6730OQ20100804

Aug 4 (Reuters) - OraSure Technologies Inc (OSUR.O) said it has delayed the filing of a new version of its recently approved hepatitis C virus test after the U.S. health regulator commented on its lower sensitivity.

The primary comments from regulators were related to the lower sensitivity of the oral fluid and fingerstick whole blood versions of the test, OraQuick HCV, compared to the venous whole blood version, which is already on the market.

The company said, based on the comments it has decided to separate the filing for the two claims.

A supplemental application for the fingerstick version was recently sent to the regulator, OraSure said, adding that the filing for the oral fluid has been delayed pending additional discussions with the U.S. Food and Drug Administration.

The company also said it is likely that more clinical data will be needed to support an oral fluid application for the test.

Marketing approval of the test in June had raised hopes of OraQuick HCV getting the nod for multiple specimen types such as oral fluid and fingerstick whole blood sample types. [ID:nSGE65O0GB]

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