The total enrollment target was comprised of 2,000 normal subjects and 1,400 women with atypical, or Ascus, Pap test results. The next steps in the clinical trial include obtaining the final colposcopy and biopsy data, validating and locking down the database, opening the database, and completing and submitting the FDA PMA applications.
Third Wave anticipates making submissions to the FDA on two human papillomavirus (HPV) products during the first quarter of 2008. The two products include a test that will screen for 14 high-risk types of HPV and a test that will enable clinicians to determine if a patient is infected with HPV type 16 or 18, the two most carcinogenic types.
Kevin Conroy, president and CEO of Third Wave, said: “We believe that the size of our study will strengthen our FDA submissions and the marketing of our HPV products, once they are approved.”