Submitted by Mechele R. Dillard
The U.S. Food and Drug Administration has approved a test identifying women at highest risk for cervical cancer.
The U.S. Food and Drug Administration has approved the Roche cobas HPV(Human Papillomavirus) Test, which identifies women at highest risk for cervical cancer. It can potentially help doctors make earlier, more accurate decisions regarding patient care, and may prevent many women from developing cervical cancer.
Persistent infection with Human Papillomavirus is the leading cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. According to the National Cancer Institute, there are 12,200 new cases of cervical cancer in the United States annually and 4,210 deaths due to the disease. The World Health Organization estimates there are 470,000 new cases of cervical cancer annually.
The cobas HPV Test is the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing. It individually identifies genotypes 16 and 18, the two highest-risk HPV genotypes responsible for more than 70 percent of cervical cancer cases, while simultaneously detecting 12 other high risk HPV genotoypes.
FDA approval for the test was based on data from the ATHENA study involving more than 47,000 women in the United States. Results demonstrated that 1 in 10 women, age 30 and older, who tested positive for HPV 16 and/or 18 by the cobas HPV Test actually had cervical pre-cancer even though they showed normal results with the Pap test.
[Note from SaneVax: Once again, the FDA has let down medical consumers. Even though DNA sequencing is recognized as the ‘gold standard’ for HPV testing, when the FDA finally approves an HPV test for medical consumers, it based on probe hybridization which the FDA has ruled as inaccurate for HPV genotyping due to cross reactivity. What is wrong with this picture?]