Cervical cancer is the fourth most common cancer among women. In the U.S., about 11,500 case are diagnosed a year, and there are 4,000 deaths a year according to the CDC. Yet screening rates are going down: In 2019 23% of women were overdue for a cervical cancer screening, up from 14% in 2005.

For many women, the hurdle to getting tested isn’t just the trip to the doctor’s office. It’s the screening itself: Cervical cancer tests involve a doctor inserting a speculum into the vagina and collecting cells, a process that some people find embarrassing and uncomfortable.

Teal Health, founded by Kara Egan and Dr. Avnesh Thakor, is on a mission to create cervical cancer screenings that can be done at home. The company has created a self-administered HPV test designed to look like a tampon applicator. “We wanted it to look welcoming and intuitive,” says Egan.

Patients insert a wand into their vagina to collect cells, which are then sent to a lab for testing. Patients meet with a doctor online, and if their results are positive, Teal Health has a network of providers it can refer patients to for additional care. “We want to expand access and reduce barriers, especially for people who are too busy to go in, don’t have access to a provider, or may have sexual trauma,” says Egan.

Teal Health hopes that by offering a self-administered option, screening rates will increase. The company’s device currently has FDA Breakthrough designation, which means, when it’s submitted to the FDA, it has priority review. Teal Health raises the question: Can and should cervical cancer screenings be administered at home?

Currently, there are two main methods for testing: a pap test, which looks for abnormal cells in the cervix and must be administered by a clinician, and an HPV (human papillomavirus) test which examines the presence of active HPV infection in cells. The U.S. Preventative Services Task Force recommends cervical cancer testing with a pap test every three years for women ages 21 to 29. For women ages 30 to 65, it recommends a pap test every three years, or an HPV test every five years, or both every five years, if all results are normal. However, one study of women under 35 in the U.K found that over a third delay testing because they are ashamed of their bodies.

[Photo: Teal Health]

Teal isn’t the only company trying to expand access to cervical cancer screenings. In May, the FDA approved two other self-administered HPV tests from BD and Roche—but unlike Teal’s test, these must be used in clinical settings. That is, patients can self-administer the tests at locations like doctors’ offices or pharmacies. While this ensures that results can be directly entered onto the medical record and follow-up care can be arranged, it doesn’t remove the barrier of actually having to go to the doctor’s office for people who live in medical deserts.

Teal’s self-administered HPV test may reduce barriers to access, but doctors warn it’s only as good as the follow-up care that patients receive. “A self-administered HPV test could be a wonderful thing, but only if it’s done properly not just in the testing but also how it is linked to follow up care,” says Dr. Sarah Feldman a gynecologist at Brigham and Women’s Hospital, and an associate professor at Harvard Medical School. “Most women don’t want a pelvic exam if they can help it.” She stresses the importance of getting a patient’s full medical history, as well as ensuring their test results are entered into their medical record. “What you do with the test results depends on a patient’s prior medical history,” she explained. People can test positive for HPV, but not have anything to worry about—the concern is a persistent infection.

Self-collection can expand access to people who don’t screen, but it shouldn’t replace in-person visits, says Dr. Kathy MacLaughlin, co-chair of the American Cancer Society’s National Roundtable work group on Cervical Cancer HPV self-collection. She says that primary care providers and gynecologists can offer self-collection to patients who don’t feel comfortable receiving a test from a doctor. The patient can administer the test, but a clinician needs to order the test, communicate the results to the patient, recommend follow-up care, and document everything.

“This should not become like the COVID test, where you walk into a pharmacy, buy the test and take it,” she says. “It requires health record documentation and follow-up with a medical team.” Both she and Feldman point out that if a patient has a persistent infection, they will have to see a provider in person and get a pap smear, so a self-administered HPV can only take a patient so far. While Teal is a good solution for patients who are avoiding the doctor’s office because of pap smears or HPV tests or forgoing testing, the best standard of care is still to have an ongoing relationship with an in-person provider.

Teal is still in the midst of working out the finer points of its delivery, including designing a standard operating procedure for patients who may be declining the test because of sexual trauma. It plans to submit to the FDA within the next few months.

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