Third Wave completes FDA filings for HPV products

Third Wave’s human papillomavirus (HPV) product submissions are based on data collected during the recently completed clinical trial for its 14-type high-risk HPV and 16/18 genotyping tests. The company achieved all primary clinical endpoints in the trial. The company expects to be in market with the instrument in 2009.

The company’s submission for its 14-type high-risk HPV test proposes two intended use claims. The first proposed intended use is in combination with a Pap test to assess women 30 and over for the presence of high-risk HPV types and to guide their treatment. The second proposes that Third Wave’s high-risk HPV test be used to test patients with abnormal Pap results to determine whether they should be referred to colposcopy. The company’s HPV genotyping test detects the presence of HPV types 16 and 18, the types that cause approximately 70% of cervical disease.