The Food and Drug Administration approved the first U.S. family cervical cancer screening tool Friday, a decision aimed at making women a replacement for Pap Smears, a decision that many consider painful or traumatic.
New tests by Teal Health involve wiping the vagina together with a sponge-like tool instead of inserting mirrors and scraping cells into the cervix like a doctor does.
A similar vaginal test was approved last year for use in medical offices. However, being at home can help women who are hard to find, travel, or make time for face-to-face dates.
Approval is the result of a process discovered decades ago Human papillomavirus (commonly known as HPV) causes almost all cases of cervical cancer, while people without the virus have little risk.
With this information, many doctors have begun testing HPV from PAP smear samples in addition to analyzing cervical cells under a microscope. Some healthcare institutions have shifted recommendations to use HPV tests as the primary screening method, which opens the door to vaginal testing because the virus can be detected in vaginal and cervical cells.
Cervical cancer experts told The New York Times that the evidence for at-home testing is strong, and studies show it is as accurate as a cervical smear.
The turquoise health will enable patients to order tests online, talk to telemedicine doctors, collect samples, and then mail for HPV testing. Teal CEO and co-founder Kara Egan said the company is working with insurers to secure coverage and working with donors to try to subsidize the costs of those who do not have insurance.
If the test is positive, the patient is referred to an in-person provider to check for PAP smear or colposcopy to check for changes in cancer or precancerous cells. (The colposcopy examines the cervix through a magnification device and allows the doctor to perform a biopsy.) If the test is negative, three to five years of further screening is required.
Teal plans to mail a round of tests to customers in California next month before expanding to other states.
Since its introduction more than 80 years ago, it has been estimated that PAP smears can prevent hundreds of thousands of deaths from cervical cancer. In 2006, the United States received a vaccine against HPV in the United States.
Vaccination and screening can prevent cervical cancer. However, it still kills thousands of Americans every year because many women do not or cannot get vaccinated or screened.
“What makes me sad is that cervical cancer is a disease we can eliminate,” said Alexi Wright, PhD, director of gynecological oncology results research at the Dana-Farber Cancer Institute. “We have tools to do that. We just don’t have a comprehensive HPV vaccination or cervical cancer screening and we usually don’t have access to people at the highest risk.”
Screening for people of color and rural residents may lag behind screening, but none consistently lag behind screening. During Teal's clinical trial, it asked participants when the last screening was conducted, and at least one in four women were in race, income, education, location, location and insurance status – already expired.
“It's really a problem that everyone feels,” Ms. Egan said.
Many women can see a gynecologist only when they are pregnant and never take preventive care. Dr. Sarah Kim, a gynecologist at Sloan Kettering Cancer Center, said home tests may be a warning to those at risk of cervical cancer that they need to see a doctor.
But Dr. King said she does not want patients to view HPV testing as a wholesale alternative to gynecological examinations.
“The most applicable places I see are for people who don’t see doctors at the moment,” she said.
In December, the draft recommendation of the U.S. Preventive Services Task Force recognized self-collected vaginal testing as an option for HPV testing and stated that HPV testing should be the primary screening method for cervical cancer in patients aged 30 and older. The task force continues to recommend PAP smears for patients under 30, but adds that the self-collected tests offer an alternative to those experiencing obstacles, those who face a doctor or find PAP smear uncomfortable.
The American Cancer Society’s recommendations are somewhat different, urging HPV testing as a primary option to start with 25.
Dr. Kathy Maclaughlin, associate professor of family medicine at Mayo Clinic, who studied cervical cancer screening, said more work needs to be done to ensure patients with positive tests can find and afford a face-to-face provider for follow-up activities, because the lack of access is the reason they may start using home tests.
She said: “Step 1 is sifting more people, but solving the problem of face-to-face visits is “important steps 2 and 3 and 4.” ”
