HPV DNA Tests Face Regulatory Hurdles

January 30, 2009
Although new studies have confirmed the need for human papillomavirus (HPV) DNA testing to help detect cervical cancer, the one test already on the market is making it difficult for smaller companies to get new tests approved, an expert says. The Digene HPV test, manufactured by Qiagen, is approved as a Class III cancer test instead of a virology test. Sin Hang Lee, a pathologist and president of HiFi DNA Tech, has filed suit against the FDA for its denial of his petition requesting reclassification of the Digene test from a Class III cancer test to a Class II virology test.
Devices & Diagnostics Letter