FDA approves first cervical cancer screening device that can be used at home, company says

CNN

09-05-2025

Cancer
Women's health
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To get screened for cervical cancer, patients in the United States may no longer need to put their feet in those awkward stirrups, brace for the uncomfortable speculum or even take the time off from work for an in-person doctor's appointment.
Soon, they will have the option to collect their own vaginal samples for screening from home – instead of a health care provider doing it for them.
The US Food and Drug Administration has approved the first at-home self-collection device for cervical cancer screening in the United States, called the Teal Wand, according to the women's health company Teal Health. Last year, the FDA gave the company's Teal Wand 'breakthrough device' status, allowing the agency to review it on a faster timeline.
Teal Wand, which will be provided in Teal Health's at-home self-collection kit, will require a prescription. Self-collected samples using the Wand are then mailed to a lab to be tested for HPV, the company announced Friday. Most cervical cancers are caused by human papillomavirus or HPV, and screening for HPV can help identify women who may be at risk of developing cervical cancer.
Typically, when screening for cervical cancer, gynecologists collect samples for HPV testing, cervical cytology or both. Cervical cytology, also known as a Pap test or Pap smear, involves examining cervical cells for changes to detect precancerous or cancerous cells. The HPV test checks cells for infection with the high-risk types of HPV that can cause cervical cancer.
Last year, the FDA greenlit similar self-collection cervical cancer screening kits for use in a medical setting, such as at a doctor's office, an urgent care or even a mobile clinic. At the time, two health care businesses – biotechnology company Roche and medical technology firm Becton, Dickson and Company – said the FDA had approved the use of self-collected samples with their respective HPV tests.
The Teal Health at-home kit allows a patient to collect their sample using the Teal Wand, which is then processed on Roche's HPV test, said Kara Egan, Teal Health's CEO. But a major difference is that the Teal Wand is approved to be used at home, so patients don't have to travel to or make time for in-person doctor appointments.
To use Teal Health's new self-collection kit, 'you request a kit at the Teal website, meet with a provider who prescribes the kit, then comfortably and privately collect at home and mail to the lab to process on the Roche Cobas HPV test,' Egan said.
'The results are then reviewed by a clinician and shared back,' she said. 'If the results are positive, a provider will meet with you and refer you to any required follow-up.'
Clinical trial data from Teal Health has found that self-collection with the Teal Wand has the same accuracy for cervical cancer screening as when a health care provider collects a sample, Egan said.
'It's the same test, same accuracy, but you can comfortably do it from home,' she said. 'It gives women more options, and with telehealth, we see more options to get access to care.'
Teal Health plans to begin shipping its at-home self-collection kits in June, Egan said, starting in California before expanding nationwide. A waitlist is available at the company's website.
Teal Health has been in talks with health insurance companies about having the self-collection kit covered, Egan added, and for people who don't have insurance, the cost of the kit will be announced within the next month.
The American Cancer Society applauded the new FDA approval.
'Despite the benefits of cervical cancer screening, not all eligible are screened regularly,' Dr. William Dahut, the society's chief scientific officer, said in an email Friday. 'Most cervical cancers are found in people who have never had a cervical cancer screening test or who have not had one recently. That's why today's Food and Drug Administration's announcement approving the first at-home test to screen for cervical cancer as an additional cancer screening method for this potentially deadly disease will make a huge impact.'
Some of the most important steps women can take to help reduce their risk for cervical cancer, according to the US Centers for Disease Control and Prevention, are to get vaccinated against HPV, avoid smoking, use condoms during sex, have regular screening tests and check with their doctor if their test results are not normal.
It's estimated that about 1 in 4 adults are not up to date on cervical cancer screening recommendations, according to data from 2021.
'Some women are scared of a traditional pap smear or find the process uncomfortable, as a result they put off this vital test,' Dr. Ami Vaidya, co-chief of gynecologic oncology at Hackensack University Medical Center's John Theurer Cancer Center, said in a news release Friday.
The newly approved at-home screening device 'could be an important tool in getting more women regularly screened, especially those that don't have access to a medical provider,' Vaidya said. 'Any type of test that helps detect cervical cancer is a win.'
The US Preventive Services Task Force recommends screening for cervical cancer with cervical cytology – also known as a Pap test or Pap smear – every three years for women ages 21 to 29. For women 30 to 65, the USPSTF recommends screening every three years with cervical cytology alone, every five years with high-risk HPV testing alone, or every five years with high-risk HPV testing in combination with cytology.
It's estimated that about 80% of people will get an HPV infection in their lifetime. HPV, a group of more than 150 viruses, is spread primarily through sexual contact and includes low-risk strains, which most often cause warts, and high-risk strains, which have been associated with an increased risk of certain cancers, such as cervical, anal, penile and oropharyngeal cancers. In most cases, HPV clears on its own within two years, but when the infection does not go away, health problems like cancer may occur.
Screening for cervical cancer remains important because early cases often may not have signs or symptoms. Advanced cases may cause abnormal vaginal bleeding or unusual discharge. Cervical cancer is treated in many ways, including surgery, chemotherapy and radiation therapy.