The U.S. Food and Drug Administration (FDA) has approved the first at-home cervical cancer screening device, giving patients an alternative to uncomfortable internal exams at the doctor’s office.
The FDA approved the new prescription test, called the Teal Wand, for individuals 25 to 65 years old who are at average risk for cervical cancer, its developer Teal Health said in a statement. For the test, a user swabs the vagina with a soft, sponge-like device to collect tissue samples instead of having a doctor insert a speculum during a pelvic exam, according to the company.
To use the Teal Wand, patients request a self-collection kit online from Teal Health, ask their healthcare provider to prescribe the test, then collect tissue samples in the privacy of their own home. The test screens for the human papillomavirus (HPV), which is responsible for nearly all cases of cervical cancer.
The lab processing the test is the same one that handles tissue samples from Pap smears, and the accuracy is comparable, according to Teal Health.
Nicole Morrison/Teal Health
Kara Egan, the cofounder and chief executive of Teal Health, said in the statement that the Teal Wand offers “women an option that makes sense for their lives — something that can be done quickly and comfortably at home.”
The company said pricing for the Teal Wand is coming soon, and that it will be HSA/FSA eligible.
HPV Causes Nearly All Cases of Cervical Cancer
More than 9 in 10 cases of cervical cancer are caused by HPV, according to the U.S. Centers for Disease Control and Prevention (CDC).
While most of these cases can be prevented with a vaccine that stops the most common strains of HPV from causing infection, physician groups still recommend routine screening because not all types of HPV can be prevented this way and not everyone gets fully vaccinated.
Teal Wand Results Are as Accurate as Those From a Pap Smear
In a clinical trial of 600 patients, researchers compared HPV screening results from tissue samples people collected at home to the results from samples collected during an in-person exam. Positive test results from the Teal Wand matched results from samples collected by a doctor 95 percent of the time, and negative test results matched 90 percent of the time, according to data reported by Teal Health.
Ninety-four percent of the patients said they would prefer the at-home test to an in-person screening exam as long as the results were reliable, according to the data reported by Teal Health. And 9 in 10 people found using an at-home testing kit to be just as comfortable or more comfortable than getting screened in a doctor’s office.
Self-Testing for HPV Is ‘Safe, Effective, and Appealing’
“It is an important advance,” says Robert Smith, PhD, the senior vice president for screening at the American Cancer Society and an adjunct professor of epidemiology at the Emory University Rollins School of Public Health.
“Some women face access barriers to regular screening, and some women and people with a cervix who have avoided or wish to avoid cervical cancer screening by a healthcare professional now have another option,” Dr. Smith says. “Self-testing at home offers an alternative for these women, and studies have shown self-testing is safe, effective, and appealing to women.”
Some People May Still Need to Get In-Office Pap Smears
The Teal Wand will not be appropriate for everyone.
“The at-home cervical cancer screening tests are a great option for many, but they’re really designed for women at average risk,” says Nasar Ahmed, PhD, a cancer researcher and an associate professor at the Robert Stempel College of Public Health and Social Work at Florida International University in Miami.
“If you’ve had abnormal Pap results, a history of cervical precancer, or a family history of related cancers, it’s important to talk to your doctor first,” Dr. Ahmed says. “You may need more frequent or specialized care.”
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Resources
Teal Wand for At-Home Cervical Cancer Screening. Teal Health.
Lisa Rapaport is a journalist with more than 20 years of experience on the health beat as a writer and editor. She holds a master’s degree from the UC Berkeley Graduate School of Journalism and spent a year as a Knight-Wallace journalism fellow at the University of Michigan. Her work has appeared in dozens of local and national media outlets, including Reuters, Bloomberg, WNYC, The Washington Post,Los Angeles Times, Scientific American, San Jose Mercury News, Oakland Tribune, Huffington Post, Yahoo! News, The Sacramento Bee, and The Buffalo News.
