On Wednesday, the Microbiology Devices Panel of the FDA’s Medical Devices Advisory Committee voted unanimously that a new HPV test could be used before or instead of the Pap.
On Wednesday, the Microbiology Devices Panel of the FDA’s Medical Devices Advisory Committee voted unanimously that a new HPV test could be used before or instead of the Pap smear as a first step in cervical cancer screening.
In three separate 13-0 votes, the panel concluded that the cobas HPV (human papillomavirus) test, made by Roche Molecular Systems, is safe and effective as a first-line screen for cervical cancer. According to Roche, the cobas HPV test is able to screen for a variety of high-risk strains of HPV.
HPV, a sexually transmitted virus, is thought to cause the majority of cervical cancers. There are several strains of HPV; some strains, such as HPV 16 AND 18, are considered more dangerous than others as they are more strongly associated to cervical cancer. Some strains of the HPV virus also cause genital warts in both men and women and certain head and neck cancers. Interestingly, the most dangerous strains of HPV are not normally those that manifest through an apparent physical deformity such as warts.
Roche intended for the FDA to approve its HPV test as a first-line diagnostic tool. Women who test positive for the two high-risk HPV strains would then be asked to undergo colposcopy, which involves using a device that allows the doctor to get a clear view of the vulva, vagina and cervix and take a sample for further testing.
In addition, women who did not have HPV 16 or 18 but had other high-risk types of the virus would then have a Pap test to see if a colposcopy was needed. The data the committee reviewed in its decision were results from the trial, ATHENA, which included more than 47,000 women.
Dr. David Chelmow, chair of the department of obstetrics and gynecology at Virginia Commonwealth University School of Medicine in Richmond, noted that “cervical cancer screening has been a huge success in decreasing cervical cancer incidence and death.” He also noted that, as a representative of the American College of Obstetricians and Gynecologists, “the college strongly supports further improving cervical cancer screening through the introduction of new paradigms such as HPV testing for primary screening. HPV testing as a primary screening method for cervical cancer is very promising, and appears effective for screening for cervical cancer.”
Dr. Andrew Menzin, a gynecologic oncologist at North Shore University Hospital in Manhasset, N.Y., said that “HPV testing has been a remarkable advance in cervical cancer screening.”
Its greatest value is helping to decide whether a follow-up colposcopy is needed, he said. “The idea of reversing the order of testing is an approach to try to refine and minimize who [unnecessarily] goes on to colposcopy,” he said.
Additionally, Menzin stated that those doctors that accept using an HPV test first instead of a Pap test strongly depends upon the clinical trial data supporting it in addition to the amount of education doctors and patients receive about the matter. He noted that current guidelines still favor using the Pap test first, “but the guidelines continue to evolve.”
Dr. Menzin stressed the importance of routine gynecological exams; he noted that, although cervical screening cancer is vital, it is not the only reason women should have a gynecological exam.
Currently, there are two approved vaccines, Gardasil and Cervarix, that can protect against HPV. The U.S. Centers for Disease Control and Prevention recommends that all young girls and boys be vaccinated beginning at ages 9 to 11.
The cobas HPV test is approved for use among women aged 21 and older who have already received an abnormal Pap test. In addition, it is also approved as an add-on to a standard Pap test in women aged 30 to 65.
The FDA is not required to follow the recommendations of its advisory panels; however, it typically does so.
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