FDA approves first HPV self-test kit

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

Women will be able to self-smear in a private setting at a doctor's office, clinic or pharmacy, after which the sample will be sent for testing.

More than half of women in the United States diagnosed with cervical cancer have never or rarely been screened, according to a press release from Roche, the manufacturer set, which announced approval on May 15, 2024.

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

Every 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 US Centers for Disease Control and Prevention (CDC).

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

“Almost all cases of cervical cancer are caused by persistent infection with certain types of HPV,” said Dr. Karen Knudsen, CEO of the American Cancer Society (ACS). “Self-selection can increase access to screening and reduce barriers, giving more people the opportunity to detect, treat and ultimately survive cancer.”

Most GPs do not test for HPV. Instead, women are most often screened by gynecologists during a pelvic exam, a procedure that 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 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 Anigne, chief scientist at the Society for Research on Women's Health, said in an interview Washington Post.

ACS recommends that cervical cancer screening begin at age 25, and that women ages 25 to 65 receive an HPV test every five years.

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

"Self-sampling was not approved by the FDA at the time of our current guidance, but we are now awaiting a minor update to the guidance to note that primary HPV testing using a sample collected by a physician or self-sampling is acceptable," the chief scientist said ACS Dr. William Dahout.

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

The approval could also open the door to home sample collection.

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

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

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