August 5, 2010

OraSure delays filing for oral version of hep C test

CORRECTED - UPDATE 1-OraSure delays filing for oral version of hep C test

Wed Aug 4, 2010 7:50pm EDT

(Corrects paragraphs two and six to OraQuick HCV instead of OraQuick)

* Says filing for oral version of HCV test delayed
* Says FDA commented on lower sensitivity of tests
* Q2 loss/shr $0.01 vs. est loss/shr $0.07
* Q2 rev $19.2 mln vs. est $17.5 mln

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]

OraSure also posted a narrower-than-expected quarterly loss on higher sales and early receipt of a milestone payment from its partner Merck & Co (MRK.N). [ID:nWNAB3728]

Shares of the company closed at $4.45 Wednesday on Nasdaq. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Unnikrishnan Nair)


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