FDA approves first HPV self-testing kit

The U.S. Food and Drug Administration (FDA) has approved a kit that will allow women to self-collect vaginal samples for screening for human papillomavirus (HPV), which could improve early detection among those at risk for cervical cancer.

Women will be able to take swabs themselves in the privacy of a doctor's office, clinic or pharmacy, after which the sample will be sent for analysis.

More than half of women in the United States diagnosed with cervical cancer have never been screened or have had it very rarely, according to a press release from Roche, the kit's maker, which announced the approval on May 15, 2024.

“Thanks to vaccination, innovative diagnostic tools and screening programmes, the WHO goal of eliminating cervical cancer by 2030 is within reach,” said Matt Souza, CEO of Roche Diagnostics. “Our HPV self-screening solution helps support this goal by reducing barriers and providing access to HPV screening, allowing people to privately collect their own samples for HPV testing.”

Each year, about 11,500 women in the United States are diagnosed with cervical cancer, and about 4,000 women die from it, according to the U.S. Centers for Disease Control and Prevention (CDC).

HPV is the known cause of more than 95% of cervical cancer cases, Roche added.

“Nearly all cervical cancers are caused by persistent infection with certain types of HPV,” said Dr. Karen Knudsen, CEO of the American Cancer Society (ACS). “Self-screening can expand access to screening and reduce barriers, giving more people the opportunity to be detected, treated, and ultimately survive cancer.”

Most general practitioners do not test for HPV. Instead, women are most often screened by their gynecologists during a pelvic exam, a procedure some do not have access to and others find too intrusive and embarrassing.

“Roche’s self-sampling solution can help reduce these barriers by offering an alternative to physician-based sample collection procedures while providing accurate and reliable results,” Roche said.

“This literally opens up another opportunity for another category of people who may not feel comfortable, or have access, or time to get tested in other settings,” Irene Anignier, chief scientific officer at the Society for Research on Women’s Health, told the Washington Post.

The ACS recommends that cervical cancer screening begin at age 25, and that women ages 25 to 65 be tested for HPV every five years.

Research over the past two decades has shown that self-selection for HPV testing is feasible and acceptable, and that women can collect samples as well as their doctors, the ACS said.

“Self-sampling was not FDA-approved at the time of our current guidance, but we now anticipate a minor guidance update to note that initial HPV testing using a clinician-collected or self-sampled specimen is acceptable,” said ACS Chief Scientific Officer Dr. William Dahut.

“We expect self-selection to play an increasingly important role in cervical cancer screening as regulatory and clinical prerequisites are met and supporting evidence continues to accumulate,” Dahut added.

Approval could also open the door to home sample collection.

Teal Health has received FDA breakthrough designation for an at-home cervical cancer screening device called the Teal Wand. Women will collect their own samples at home, then send them to a lab for HPV testing.

This designation gives Teal Health priority status from regulators once clinical trials are completed and data is submitted to the FDA.

"No more stirrups, no more mirrors." "The Teal Wand replaces the need for an in-office Pap smear by using stirrups, a mirror, and a stiff plastic brush or broom. With self-selection, you control the process."