Pap smear has long been the standard test for detecting cervical cancer but a new screening option will be available soon as federal health regulators finally gave the go signal for the first HPV DNA test for the primary screening of cervical cancer.
On Thursday, April 24, the Food and Drug Administration gave the thumbs up for Roche Molecular Systems' HPV DNA test for women who are at least 25 years old. The Cobas HPV test will be used to evaluate whether a woman needs further testing for cervical cancer, a disease that more frequently affects women over 30 years old. The test can also be used by health professionals to gauge the likelihood of a woman to develop cervical cancer.
The United States Centers for Disease Control and Prevention (CDC) says that about 12,000 women in the US develop cervical cancer per year. Of these, 4,000 die from the disease. The primary cause of cervical cancer is the Human papillomavirus (HPV), a common virus transmitted through sexual contact. Although not everyone who has HPV infection will develop cancer, a tenth of the women with HPV infection will develop cervical cancer.
The Cobas test works by detecting DNA from 14 types of human papillomavirus virus responsible for almost all cases of cervical cancer including the HPV 16 and HPV 18 strains that cause about 70 percent of cervical cancers.
Women found to have the HPV 16 or HPV 18 strains need to undergo colposcopy, a procedure that closely examines the cervix. Women screened positive for any of the HPV strains considered high risk will undergo Pap test to assess whether they need a colposcopy or not.
The test was already green-lighted by the FDA in 2011 but only for use as a follow up to or in combination with Pap test. With FDA's new decision, the Cobas can now be used as a primary cervical cancer screening test. It can also be used by women alone or with the assistance of their health care provider.
"Today's approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test, however; it does not change current medical practice guidelines for cervical cancer screening," the FDA said.