- The FDA approved the first at-home self-collection test to screen for cervical cancer, providing females with an alternative to pap smears.
- The test, manufactured by Teal Health, could help make cervical cancer screening more accessible, echoing recent guidelines issued by the U.S. Preventive Services Task Force.
- The Task Force recommends three screening methods for cervical cancer, among them, self-collection for HPV samples.
- Cervical cancer death rates in the U.S. are declining due to regular screening, but Black and Hispanic women still face disproportionately high risks.
Cervical cancer continues to be a leading cause of disease-related death
In the United States, where regular screening for cervical cancer is widely available, mortality rates have fallen by 70% since the 1950s.
Most cervical cancer cases are caused by human papillomavirus (HPV), a sexually transmitted infection (STI). Current guidelines for cervical cancer screening recommend HPV testing every 5 years for females ages 30 to 65.
For younger females ages 21 to 29, a Pap test every three years continues to be the
On May 9, the Food and Drug Administration (FDA) approved the first at-home self-collection test for cervical cancer. As an alternative to pap smears, the Teal Wand, provided by Teal Health, will still require a prescription and offer a “much preferred experience,” the company said in a statement.
Teal Health CEO and co-founder Kara Egan told Healthline the FDA approval of the product gives women an option for testing that can be done quickly and comfortably at home.
“When we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day,” Egan said.
The approval of the at-home test echoes a recent U.S. Preventive Services Task Force (UPSTF) recommendation for cervical cancer screenings.
The Task Force recommended self-collected HPV tests to screen for cervical cancer starting at age 30, and anticipated that self-collection would increase screening rates among those who experience discomfort during traditional screening methods or face other barriers to care.
Samples collected using a swab yield just as accurate results as when a sample is collected by a clinician, UPSTF stated.
Self-collection also provides an alternative for females who face barriers to care and are under-screened, particularly among Black and Hispanic women, who face disproportionately high cervical cancer risks.
“Most cases of cervical cancer are in women who have not been regularly screened or appropriately treated after an abnormal test result,” Task Force chair Wanda Nicholson, MD, MPH, MBA, said in a statement last year. “That’s why it’s so important that women get screened regularly, so cancer can be prevented or caught early when it’s treatable.”
The Task Force recommends three screening methods for cervical cancer — HPV tests, Pap tests (cytology), and co-testing (Pap and HPV) — to help detect early signs of the disease in those assigned female at birth.
The UPSTF advises patients to work with their healthcare team to choose a screening method that best suits their personal health.
“Protecting choice in screening methods is crucial to ensuring that OB-GYNs and other healthcare professionals can continue to provide the lifesaving tests women need,” Jessica Shepherd, MD, board certified OB-GYN at Sanctum Med + Wellness in Dallas, Texas, and Chief Medical Officer at Hers, told Healthline in a December 2024 interview.
Following the release of the UPSTF cervical cancer screening guidelines, Healthline spoke with Shepherd to learn more about self-collection and other screening methods for cervical cancer prevention.
This interview has been edited and condensed for clarity and length.
Shepherd: The UPSTF cervical cancer screening draft guidelines maintain access to all current screening methods, and the Task Force noted that all three screening methods — HPV tests, Pap tests, and co-testing — are effective and recommended.
The patient experience remains the same no matter the screening strategy used, and for women 30+, co-testing provides more information to inform care decisions.
Additionally, the Task Force noted that current evidence continues to show that getting a Pap test every three years is the best screening approach for women ages 21 to 29.
Shepherd: The UPSTF recommends women begin cervical cancer screenings at age 21 with the Pap test every 3 years. Pap testing is the most effective method for these younger women because most HPV infections in this age range resolve on their own.
Once patients are 30+, the Task Force recommends screening every 5 years with Pap+HPV together (co-testing), every 3 years with the Pap test, or every 5 years with HPV testing alone.
Shepherd: While some view HPV self-collection as a potential way to increase access, Food and Drug Administration (FDA)
No matter what testing method is used, patients still need to come in for a screening appointment.
The FDA noted when they approved HPV self-collection that if women who are regularly screened switch to self-collection, it could result in “potential missed cervical disease cases that could have otherwise been detected and prevented using the current standard of care.”
Ultimately, increasing screening participation and improving cervical cancer care will require a multi-faceted range of solutions, which is why I believe so strongly in the importance of the patient-provider relationship to discuss these factors and find the right solution for each woman.
Shepherd: Black women are
We also know that Hispanic women are 40% more likely to be diagnosed with cervical cancer compared to white women and 26% more likely to die from the disease.
These concerning trends occur due to several factors, including a lack of access to insurance and appropriate treatment.
We often see that many women believe they will experience financial barriers to screening appointment costs and potential follow-up care or treatment. This underscores the importance of screening guidelines that preserve access to all options for women.
Changes that would restrict options would contribute to higher rates of disease, worsening existing inequities in care and outcomes for these groups.
Shepherd: Cervical cancer is preventable with regular screening. More than 50% of new cervical cancer cases occur in women who have never been screened or haven’t been screened in the past five years. A focus on improving [HPV] vaccination is also imperative.
Women deserve to feel empowered to take charge of their cervical health. Annual well-woman visits help women stay up to date with essential screenings by their doctor, including Pap tests and co-testing — while also helping patients and doctors build stronger relationships.
