Gen-Probe (GPRO,$51.60) announced yesterday that it submitted a Premarket Approval Application(PMA) the the FDA for its APTIMA HPV (human papillomavirus ) assay , a molecular diagnostic test that detects high-risk HPV infections that are associated with cervical cancer and precancerous lesions. The APTIMA HPV assay is an amplified nucleic acid test for 14 high-risk HPV types that are associated with cervical cancer. The test would be run on its TIGRIS fully automated system that is being used today in 200 U.S. clinical laboratories to test for chlamydia and gonorrhea. Based upon similar PMA submissions the APTIMA test could be cleared through the FDA by year-end 2011. The global market for HPV tests is in the range of $350M of which 80% is in the U.S. The competitors are Qiagen(QGEN),Hologic (HOLX) and Roche (ROG.VX).
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