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FDA Clears Gen-Probe HPV Assay

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Gen-Probe's Aptima HPV assay, a molecular test to detect high-risk strains of human papillomavirus.

The test runs on the firm's fully automated, high-throughput Tigris instrument system. It detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Gen-Probe added that the Aptima HPV assay, unlike other FDA-cleared tests detects messenger RNA over-expressed from two viral oncogenes that are integral to the development of cervical cancer.

"FDA approval represents a major milestone for the company, since developing the Aptima HPV assay was the largest and most complex diagnostic R&D program we have ever completed," Gen-Probe President and CEO Carl Hull said in a statement.

The test is approved for women age 21 and older whose Pap tests showed atypical squamous cells of undetermined significance and to screen women age 30 and older as an adjunct to Pap testing.

Gen-Probe said that it expects to launch the Aptima HPV test in the US within the next two weeks. It anticipates recording its first revenues from the assay in the US during the first quarter of 2012.