The Food and Drug Administration approved the first at-home screening tool to detect cervical cancer, offering an alternative to the traditional Pap smear typically performed in a doctor’s office.
The wand developed by Teal Health allows patients to self-collect a vaginal sample and mail it to a lab for testing. The sample is analyzed for high-risk strains of human papillomavirus, known as HPV, a sexually transmitted infection that causes nearly all cervical cancer cases.
Every year, there are about 11,500 cases of cervical cancer diagnosed in the United States, and around 4,000 people die, according to the Centers for Disease Control and Prevention.
Because of screening tools and the HPV vaccine, cervical cancer is one of the most preventable cancers, according to Emily Ko, an associate professor of gynecologic oncology at the Perelman School of Medicine at the University of Pennsylvania.
“There is still a large proportion of women who could be screened for cervical cancer but are not getting screened because of various reasons,” said Ko. “Being able to extend this to home screening will help fill that gap.”
Is the at-home test the same as screening at the doctor’s office?
It’s very similar. Though the method for collecting a sample is different, the screening wand uses the same HPV tests that are FDA-approved and recommended by the American Cancer Society and the U.S. Preventive Services Task Force. It offers the same clinical accuracy as tests used in doctors’ offices.
By moving the collection process into a person’s home, the wand will remove some of the hurdles people face that keep them from getting screened.
“We know that access to a facility can be a big barrier for people,” said Colleen Denny, an associate professor in the obstetrics and gynecology department and director of family planning at NYU Langone Hospital in Brooklyn. “It may be more comfortable for people with a history of trauma or gender dysphoria to screen themselves.”
How does the at-home testing work?
The process begins with a virtual visit to review a person’s health history and determine eligibility. If approved, a test kit is shipped to the patient’s home, where they collect a sample and return it to the lab.
The sample is tested for HPV, and Teal providers review the results. If follow-up care is needed, referrals will be provided. The tests are approved for people aged 25 to 65 with a cervix.
Some reproductive-health experts say a pitfall could be a false positive, which may cause some patients to worry. Denny said that while most people will have HPV at some point, and it often clears on its own, a positive result still requires proper follow-up.
“The screening could be problematic if people don’t know what to do next. A positive test doesn’t mean you have cancer, but it does mean you need more screening and support to navigate that,” Denny said.
How much does it cost, and how do you purchase it?
Teal Health has not set a cash price for its at-home cervical screening test but says it is working with insurers to ensure affordability. The company is already in-network with most major insurers in California and is expanding nationally.
When the product launches, payment options include insurance coverage, out-of-pocket pay, and HSA and FSA reimbursement, Teal Health said.
Kara Egan, the CEO and co-founder of Teal Health, said she hopes the device will bridge the gap in women’s care, especially for people who may not have access to gynecologic care.