FDA approves Gen-Probe's HPV assay

FDA approved a PMA from Gen-Probe Inc. (NASDAQ:GPRO) for its Aptima HPV assay to detect 14 high-risk HPV types associated with cervical cancer and precancerous lesions. The test is indicated to screen women 21 years and older whose Pap tests showed atypical squamous cells of undetermined significance, and to screen women 30 years and older as an adjunct to Pap testing. The assay is an amplified nucleic acid test that detects E6 and E7 mRNA associated with progression of HPV to cervical cancer. The company plans to launch the assay in the U.S. within the next two weeks. Gen-Probe was down $1.67 to $60.10 on Monday. ...