FDA OKs Gen-Probe HPV test

The FDA has given its blessing to Gen-Probe's ($GPRO) APTIMA HPV assay, an amplified nucleic acid test that detects 14 high-risk HPV types 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.

Unlike available DNA-based tests, the APTIMA HPV assay detects messenger RNA over-expressed from two viral oncogenes that are integral to the development of cervical cancer, according to a company release. The approval was based on data from the CLEAR trial, which evaluated roughly 11,000 women undergoing routine Pap testing at 18 U.S. clinics. The APTIMA HPV assay showed similar sensitivity for the detection of cervical disease as a DNA-based test. However, the specificity of the APTIMA HPV assay was higher than that of the other test, and this advantage was statistically significant.

"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 Dr. Tom Wright, professor of pathology and cell biology at the Columbia University Medical Center, in a statement. "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. This means the APTIMA HPV assay is highly accurate in detecting cervical disease, but is less likely to raise false alarms that can result in unnecessary medical procedures."

The APTIMA HPV assay is approved to test women age 21 and older whose Pap tests showed atypical squamous cells of undetermined significance. It can also be used to screen women age 30 and older as an adjunct to Pap testing.

The approval marks another big step in efforts to identify women with high-risk HPV. Earlier this year, Roche got the FDA's OK for its cobas HPV test, which individually identifies genotypes 16 and 18. These two HPV strains are responsible for more than 70% of cervical cancer cases.

- check out the Gen-Probe release

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