The FDA has approved America’s first at-home alternative to the Pap test, which for decades many women have feared and frequently experienced as uncomfortable.
The new device by
Teal Health
Will provide a “highly favored experience,” the firm stated in its release, with the additional aim of boosting examination rates by simplifying the process.
Historically, gynecologists have placed a chilly metallic speculum far into a woman’s vaginal canal with the purpose of collecting cervical cells for examination.
The Teal Wand — described as “constructed with empathy” by the company — utilizes a swab to obtain a vaginal specimen. Afterward, women are instructed to send this sample to a laboratory where they will test for HPV (human papillomavirus), the virus responsible for almost all cases of cervical cancer. An increasing amount of evidence supports this approach.
HPV testing
to be highly accurate.
The FDA’s approval came through on Friday following a
U.S.-based study
The research discovered that screenings conducted at home were equally effective compared to those performed in a medical setting. Additionally, the study revealed that most women favored conducting their own screenings from home and indicated this method would increase their likelihood of regularly undergoing cervical cancer screenings.
Every year, about
13,000 cases
Of those diagnosed with cervical cancer, over 4,000 women succumb to the illness each year. However, these rates have plummeted significantly since.
Dr. Georgios Papanicolaou
Published a 1943 study detailing the utilization of the Pap smear for screenings, which subsequently gained widespread adoption.
But about a
quarter of women
in the U.S. are behind on such screenings, and medical experts say reducing that is key to the ultimate goal of eliminating cervical cancer. There’s also a
racial gap
, with Black and Native American women far more likely to die from cervical cancer than white women. The
HPV vaccine
for teen and preteen girls, introduced in 2007, has also led to a global push to tackle the disease that way.
Cervical cancer screening at home is already accessible in various other nations, such as
Australia
and
Sweden
.
Teal Health says its self-testing device will be available starting next month, in California first and then expanding. It will be by prescription, through a telehealth service, for women 25-65 years old who are “at average risk.” The company says it’s working with insurance companies to provide coverage.
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