FDA Approves Molecular Test to Detect HPV


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FDAlogoGen-Probe recently announced that the FDA has approved its APTIMA HPV assay, an amplified nucleic acid test that detects high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. The test has been approved to run on Gen-Probe’s fully automated, high-throughput TIGRIS instrument system.

The APTIMA HPV assay detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Testing is performed from ThinPrep liquid cytology specimens routinely used for Pap testing. Unlike other FDA-approved, DNA-based HPV tests, the APTIMA HPV assay detects messenger RNA overexpressed from two viral oncogenes that are integral to the development of cervical cancer.

“Most HPV infections clear up on their own, so it’s important to identify those persistent, high-risk infections that are most likely to lead to cervical cancer,” said Tom Wright, MD, Professor of Pathology and Cell Biology at the Columbia University Medical Center. “In numerous clinical studies involving approximately 45,000 women, the APTIMA HPV assay has consistently shown similar sensitivity and better specificity than the most frequently used DNA-based test.”

The APTIMA HPV assay is approved to test 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.

FDA approval was based on data from the CLEAR (CLinical Evaluation of APTIMA HPV RNA) trial, which analyzed approximately 11,000 women undergoing routine Pap testing at 18 U.S. clinics. In the study, the APTIMA HPV assay showed similar sensitivity for the detection of cervical disease as an FDA-approved, DNA-based test. However, the specificity of the APTIMA HPV assay was higher than that of the DNA-based test, and this advantage was statistically significant. ■



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