FDA Okays First HPV Test for Primary Cervical Cancer Screening

The federal health regulators have passed a HPV DNA test proposed by Roche as a primary screening option for cervical cancer in women aged 25 and above.

The U.S. Food and Drug Administration cleared the HPV genetic test that can be used as a stand-alone test to assist health care professional estimate the need for a women to undergo additional diagnosis for possible cervical cancer, known to be the third most common type of cancer in women.

The newly approved genetic test offers information on a woman's risk of developing cervical cancer in future.  This is approved as an alternate to the Pap test, another screening test for cervical cancer.

"Today's approval offers women and physicians a new option for cervical cancer screening," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health. "Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer."

The new cobas HPV Tests uses a sample of cervical cells and successfully detects DNA from 14 high-risk HPV types that trigger the risk of cervical cancer. This test mostly identifies HPV 16 and HPV 18 and simultaneously detects 12 other types of high-risk HPVs.

The next procedure after this test depends on the result. If women are tested positive after the cobas HPV test for HPV 16 or HPV 18 they would have to go for colposcopy. This is another test that is done using a device that light up and magnifies the cervix making it clear for the physician to directly observe the cervical cells.  Those women who were tested positive for one or more of the 12 other high risk HPV types they would be referred for a Pap test that will further determine the need for colposcopy.

The federal regulators caution that the health care professionals should use the results of the cobas HPV Test along with other data that includes patients screening history and risk factors.

The cobas HPV Test was initially approved in 2011 for use in conjunction with or as a follow-up to a Pap test that examines the cervical cells for detecting the deadly cancer.

The latest approval does not change medical practice guidelines for cervical cancer screening but just expands the use of it as a co-test or a primary cervical cancer screening test. 

According to the Centers for Disease Control and Prevention, genital HPVs are basically a group of over 40 related viruses that are mostly sexually transmitted infections.  There are 14 high-risk HPV types that are linked with cervical cancer.

Most often the infection occurs and fades on its own without triggering major health problems but 10 percent of the women, who are infected with the high-risk HPV, are likely to develop a persistent infection that puts the women at risk of the cancer.

The data in which cobas HPV test was used as a primary screening test for cervical cancer included over 40,000 women of ages 25 years and older who were undergoing routine cervical exams.

"Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV Test results. Data from this study, which included three years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use," FDA explained.

The test is manufactured by Roche Molecular Systems, Calif.