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.
“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.”
