The Food and Drug Administration (FDA) approved the first at-home kit for self-collecting samples for cervical cancer screening for people ages 25 to 65 at average risk, according to Teal Health, the women’s health company that developed the test, the Teal Wand.

 

Cervical cancer develops when cells grow out of control in the uterine cervix. Almost all cases are caused by human papillomavirus (HPV). In the United States, cervical cancer is relatively uncommon thanks not only to an effective HPV vaccine but also to routine screening with HPV tests and Pap smears, which can detect abnormal precancerous cells and allow for early treatment and increased likelihood of long-term survival.  

 

View this post on Instagram

A post shared by Teal Health (@teal.health)

 

The Teal Wand features a wand with a soft spongelike tip for collecting cells. Because it does not use a speculum—the metal tool traditionally used by clinicians to scrape cells from the cervix during a Pap smear—it does not test for abnormal precancerous cells but rather for cancer-causing HPV types.

 

Once patients are done with collection at home, they ship their sample to a certified lab for testing. If the sample is positive, patients must follow up with a colposcopy to confirm the presence of abnormal tissue.

 

The approval of the Teal Wand signals a new era in health care centering women’s comfort, control and personal preferences. Additionally, the at-home kit is a great option for people who may have limited access to preventive cancer care.

 

View this post on Instagram

A post shared by Teal Health (@teal.health)

 

FDA approval is supported by the SELF-CERV study, which included more than 600 participants who self-collected a sample using the device.

 

Nearly every woman in the study (98%) successfully collected a valid sample, and most (93%) said the device was easy to use. What’s more, about 94% said they would prefer self-collection at home if they knew the sample would yield test results as accurate as if it had been collected at a doctor’s office.

 

View this post on Instagram

A post shared by Teal Health (@teal.health)

 

“As a principal investigator in the SELF-CERV trial, I saw firsthand how receptive and excited women were to use the Teal Wand,” said Christine Conageski, MD, MSc, associate professor, OB-GYN and director of the Complex Dysplasia Clinic at the University of Colorado, in a Teal Health news release. “But access is only part of the solution. Comprehensive screening must go hand in hand with structured, reliable follow-up. That’s why Teal Health’s approach to not only advancing screening technology but also providing education and support to women through every step of their care and follow-up journey is crucial. That’s how we ensure this breakthrough truly closes the gap.”

 

For now, the Teal Wand requires a prescription from one of the company’s online health providers. However, Teal Health is working with insurers to provide coverage.

 

Teal Health will begin selling the kits in California in June before expanding to other states.

 

In related news, the U.S. Preventive Services Task Force recently announced plans to add  HPV testing via self-collection to its recommendations for cervical cancer screening. This will likely mean the home test will be covered by insurance.

 

To learn more, click #Cervical Cancer or #Cancer Screening. There, you’ll find headlines such as “A Single HPV Vaccine Dose Offers Good Protection,” “What’s Your HPV IQ?” and “Resources for Cervical Cancer.”