Third Wave submits HPV PMAs
This article was originally published in The Gray Sheet
Executive Summary
Molecular diagnostics firm submits PMA applications for its two human papillomavirus (HPV) tests based on clinical trial data reported last month and continues to develop a testing instrument for use with the assays, Third Wave says April 28 (1"The Gray Sheet" March 24, 2008, In Brief). Third Wave Technologies' screening test for 14 high-risk types of HPV is intended to be used in combination with a Pap test in women 30 years and older, and in patients with abnormal Pap results to determine whether they should be referred to colposcopy. The second screening test detects HPV types 16 and 18, which cause about 70% of cervical disease, Third Wave says. The company expects to market the tests and testing instrument in 2009. Third Wave estimates the global HPV testing market at $250 million, with $1 billion potential