FDA Approves Gen-Probe's Aptima HPV Test

The Food and Drug Administration has approved use of a new human papillomavirus test in certain clinical scenarios, the San Diego-based firm Gen-Probe announced Oct. 31.

Gen-Probe’s Aptima HPV test uses a Pap smear sample to look for an overabundance of messenger RNA resulting from two cancer-causing genes that only appear in persistent infections. In studies involving approximately 45,000 women, Aptima was more sensitive to higher-risk HPV than other comparable tests for HPV’s DNA, said Dr. Tom Wright, a pathology and cell biology professor at Columbia University Medical Center in New York who was an investigator in the main trial.

By doing a better job of detecting chronic infections that are more likely to trigger malignant cell growth, Aptima could help prevent unneeded exams, biopsies, and treatments. “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,” said Wright.

Up to 17 percent of women age 30 and older receive positive HPV results without any evidence of cervical lesions, according to the US Preventive Services Task Force.

Aptima is approved for use in two groups of women: those age 21 and older whose Pap indicates abnormal cellular changes that are not clearly cancerous; and those 30 and older who receive the HPV test concurrent with a Pap smear. Gen-Probe spokesperson Michael Watts said Aptima has been available in Europe since 2008. The test could launch in the United States during the next few weeks, he said.

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