HPV Test Approved for Expanded Cervical Cancer Screening
The Pap smear, which for decades has been the lone primary screening for cervical cancer, now has company.
The Food and Drug Administration has approved a new HPV (human papillomavirus) DNA test called cobas as another primary screening. Roche Molecular Systems Inc. developed the test. According to the Centers for Disease Control and Prevention, 11,818 American women were diagnosed with cervical cancer in 2010.
“Over the past 30 years we have done a remarkable job preventing cervical cancer through the use of Pap smears. In recent years, we have added the HPV test to help us better understand a person's risk of developing cervical cancer,” explains Rick Henriksen, M.D., M.P.P., director of the Primary Care Track and Family Medicine Clerkship at the University of Utah School of Medicine.
Almost all cervical cancers are caused by two types of HPV. HPV is a sexually transmitted disease that comes from skin-to-skin contact. One startling statistic: More than half of sexually active people are infected with some strain of HPV at some point in their lives, according to the National Cancer Institute.
Still, most high-risk HPV cases resolve on their own and will not become cancerous.
The cobas test detects DNA from 14 high-risk types of HPV, specifically flagging forms 16 and 18, which are responsible for 70 percent of cervical cancers. Positive results will mean a woman needs further testing. The FDA first approved the cobas HPV test in 2011 to be used simultaneously with a Pap test or as a follow-up.
It is important to note that this test is limited to women 25 and older.
The American Cancer Society says it is reviewing the FDA approval of cobas as a stand-alone test for cervical cancer. For now, its screening guidelines remain that women get a Pap test every three years, or an HPV and Pap test together every five years.
Henriksen agrees. “The guidelines still state that we should do a Pap test every three to five years. I think we need more research on HPV screening alone to determine if it is adequate to prevent cervical cancer.”
In fact, despite the FDA approval of cobas, most patients will not notice much of a difference during their Ob-Gyn visit, according to Henriksen.
“All the HPV tests require cervical cells just like a Pap test. The time and discomfort of the pelvic exam would still be required with the new test,” he says.