Gen-Probe HPV test
This article was originally published in The Gray Sheet
Executive Summary
San Diego firm launches its Aptima molecular assay for human papillomavirus (HPV) in Europe May 28 upon gaining a CE mark. The assay, which detects 14 high-risk HPV types associated with cervical cancer, runs on Gen-Probe's Tigris and DTS instrument platforms. The firm began a 7,000-patient pivotal trial for U.S. approval of Aptima in March (1"The Gray Sheet" April 7, 2008, In Brief). Qiagen/Digene's Hybrid Capture 2 is the only FDA-approved molecular test for HPV