FDA approves self-collection screening for virus that causes cervical cancer

The Food and Drug Administration this week moved to expand screening for potentially lethal cervical cancer by allowing women to collect test samples themselves, a move that reproductive health advocates view as crucial to stamping out the preventable disease.

For the first time, women will be able to gather samples for testing in private rooms inside offices of primary-care doctors, at urgent-care clinics and even pharmacies — an advance that could presage home testing.

Advocates hope the method will make it easier for women of color and those living in rural and underserved communities to screen for human papillomavirus — HPV — which can lead to a cancer that afflicts 11,000 each year. It comes as the National Cancer Institute has ramped up study of self-collection, partnering with 25 medical schools and cancer centers across the country to gauge use of collecting vaginal samples at home and at health-care facilities.

“It provides women who might not have otherwise had the opportunity — or inclination — to get screened the chance do so,” said Erin Kobetz, associate director for community outreach and engagement at the University of Miami Sylvester Comprehensive Cancer Center, who has studied self-collection for HPV testing for nearly two decades. “Maybe it makes this idea, at least in the United States, of eliminating cervical cancer by 2030 a perceptible reality.”

The collection method was greenlit for the previously approved HPV test Onclarity, manufactured by BD (Becton, Dickinson and Company). The test is expected to be available in summer and will be part of a study of self-collection, the company said in a news release Wednesday.

Roche also received sign off for the self-collection method for its cobas HPV Test, and has been collaborating with the NCI’s study, the company said in a news release.

Meanwhile, the FDA could sign off on at-home collection in coming months. Teal Health created a device that lets women collect their own vaginal samples and send them to a laboratory for testing. Last week, the test received a special designation from the FDA that allows agency staffers to review certain devices faster.

Most primary-care physicians do not test for HPV. Typically, it’s performed by gynecologists, who collect samples for an HPV test or for a Pap smear for abnormal cervical cells. Often, the samples are taken during a pelvic exam.

The new method “opens the door to a less invasive testing option,” the company said. It will still require an order from a doctor, who will be required to explain the results. But the samples can be collected by a woman using a vaginal swab in a health-care facility “like you would a urine sample,” said Jeff Andrews, vice president of medical affairs for BD. The swab is then sent to a lab equipped to test the sample.

Andrews added the test is already covered by private insurance, Medicare and Medicaid, which typically pays clinical, hospital and other labs about $46 per screening. BD sells the tests to labs.

Self-collection won’t replace testing for HPV during routine pelvic exams, but it will add another way to improve earlier detection of the infection.

“This literally just opens up another option for a different demographic of people that might not feel comfortable, that might not have access (and) may not have time” to get tested otherwise, said Irene O. Aninye, chief science officer for the Society for Women’s Health Research, a group focused on advancing women’s health and promoting research.

The method has already proved successful in European countries and Australia.

Now, federal researchers are beginning to gather data on whether self-collection works well in the United States. NCI in January launched its initiative to study self-collection, aiming to answer critical questions.

“The study will provide us the data to know what’s the uptake like, what do people do with this information? How is it received in different clinical settings, and do people engage with their gynecologists in a different way? And then ultimately, do we see a difference in cervical cancer cases?” NCI director Kimryn Rathmell said.

In the United States, the FDA’s approval of the BD test is the culmination of decades of research. Kobetz began studying self-collection in Miami’s Little Haiti neighborhood, where women of Haitian heritage shied away from Pap smears for complex reasons, including the perception the tests were intrusive and concerns about intimacy and vulnerability, Kobetz said.

Her study found self-collection was accurate — women who participated in the study obtained enough cells to test for HPV and they “really found this to be an appropriate method for cervical cancer screening — and an easy one,” Kobetz said.

The goal is for at-home tests to become easily available, said William L. Dahut, chief scientific officer at the American Cancer Society. Doing so, he believes, would increase the number of people who get screened for HPV.

In 2006, the FDA approved the first vaccine to prevent HPV, but uptake varies widely by state. The shots have the potential to prevent more than 90% of HPV-attributable cancers, according to the Centers for Disease Control and Prevention. While vaccination significantly reduces the chance of infection, it doesn’t eliminate risk of cervical cancer, so it remains important for people to get screened,