The U.S. Food and Drugs Administration has approved the first human papillomavirus test for primary cervical cancer screen for women above 25 years of age.
The test can be used by physicians to determine whether a woman needs to undergo additional diagnostic testing for cervical cancer. It can also help determine a woman's risk of developing the disease later in the future.
"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 in a press statement. "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 already received an FDA approval in 2011 but was meant to be used only in conjunction with or as a follow-up to a Pap test. The new approval confirms that it can be used either as a co-test or as a primary cervical cancer screening test,
This is how the test works. It detects DNA from 14 high-risk HPV types among samples of cervical cells, specifically identifying HPV 16 and HPV 18.
It is recommended that women who test positive for HPV 16 or HPV 18 in the cobas HPV should have a colposcopy, an exam using a device that illuminates and magnifies the cervix so a physician can directly observe the cervical cells. Additionally, the women who test positive for one or more of the remaining high-risk HPV types should have a Pap test to determine the need for a colposcopy. Physicals should also take into account other information of the patient including screening history and risk factors, along with current professional guidelines.
Evidence of the effectiveness of the test was provided through a study conducted on more than 40,000 women that were above 25 years and 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.," the agency revealed. "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."
Genital HPVs are a group of more than 40 related viruses. According to the CDC, these viruses are the most common sexually transmitted infection. In fact, it is so common that nearly all sexually active men and women get it at some point in their lives. In most cases the infection is cured without medication and doesn't cause any health problems. However, 10 percent of women infected with high-risk HPV develop a persistent infection which may put them at risk of cancer. HPV 16 and HPV 18 are responsible for causing 70 percent of cervical cancers.
