NEW YORK (GenomeWeb News) - Third Wave Technologies said today that it has completed patient enrollment for a clinical trial involving its two human papillomavirus tests.
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The company said it has enrolled 2,000 normal subjects and 1,400 women with atypical Pap test results. Next steps in the clinical trial include obtaining final colposcopy and biopsy data, validating and opening a database, and submitting pre-market approval applications to the US Food and Drug Administration.
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The company said it expects to file for FDA approval for two HPV products in the first quarter of 2008. One is a test that will screen for 14 high-risk types of HPV and the other is a test for HPV types 16 and 18, the two most carcinogenic types of the virus.