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Gen-Probe receives FDA approval for APTIMA HPV assay

October 13, 2017

The APTIMA HPV assay is approved to test women age 21 and older whose Pap tests showed atypical squamous cells of undetermined significance (ASC-US), meaning they were neither normal nor clearly indicative of pre-cancerous changes, and to screen women age 30 and older as an adjunct to Pap testing.  This means the assay can be used to meet consensus guidelines for cervical cancer screening recommended by leading US medical organizations.  "Physicians can use the APTIMA HPV test to make early, more accurate decisions about patient care, which in turn may prevent many women from developing a potentially deadly disease," Dr. Wright said.

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 US 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.

SOURCE Gen-Probe Incorporated