FDA Okays Roche's HPV Test for Primary Cervical Cancer Screening

The U.S. Food and Drug Administration (FDA) has okayed the use of Roche's HPV DNA test for women 25 and older. The test can be used by healthcare professionals to check whether the woman needs to undergo diagnostic tests for cervical cancer. The cobas HPV Test detects DNA from 14 high-risk HPV types, the agency said. The test specifically looks for HPV 16 and HPV 18 strains. Based on the test results, the woman can undergo colposcopy where a doctor looks at the cervix cells or a Pap test. The Pap test determines whether the woman needs additional testing for cervical cancer. According to Centers for Disease Control and Prevention, genital HPVs are common sexually transmitted infections. Around 14 of the 40 genital HVV strains are associated with cervical cancer, the agency said. HPV 16 and HPV 18 are linked to around 70 percent of cervical cancers. "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, according to a news release. "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 cobas HPV Test was approved for use in 2011. The test was to be used alongside the Pap test. However, now the test is approved as a primary screening method for HPV. The Pap test looks for abnormal cells in the cervix. Both Pap and HPV test require a vaginal swab, CNN reported. "We are very pleased that the FDA has approved this test for first-line use in cervical cancer screening. It is a recognition for the value the cobas HPV Test provides to physicians and women to make more informed decisions that can ultimately prevent cervical cancer development," said Roland Diggelmann, COO Division Roche Diagnostics, according to a news release. The data for the study came from 40,000 women 25 years and older who had undergone several tests for cervical cancer. Researchers found that the new HPV test was better than Pap test in detecting cancerous lesions, The Time reported.