Women will be able to use a cyan and healthy wand to screen for cervical cancer at home. Blue and green Closed subtitles
The Food and Drug Administration has approved the first U.S. replacement for home-based sheepskin smears, but generations of women are scared and often feel pain.
The company said in its announcement that Teal Health’s new devices will provide “extremely priority experience” and aim to improve screening rates by making the process more convenient.
Traditionally, gynecologists have inserted cold metal spectacles deep into a woman's vagina to scrape cells from her cervix.
The turquoise wand is “built with empathy” — using swabs to collect vaginal samples. The woman will then mail the sample to a lab that will screen for HPV (human papillomavirus), which causes almost all cervical cancer. More and more studies have found that HPV testing is very accurate.
Friday, the FDA approval came after a U.S.-based study that found that at-home screening was as effective as doctors’ offices. The study also found that women enjoy self-covering very much at home and said they are more likely to stay up to date in this way.
About 13,000 cervical cancers are diagnosed each year, and more than 4,000 women die from the disease. Since Dr. Georgios Papanicolaou published his 1943 paper on how to use PAP smears for screening, rates have been greatly reduced and then become common.
But about a quarter of women in the United States lag behind such screening, and medical experts say the reduction is key to the ultimate goal of eliminating cervical cancer. There is also a racial gap in which black and Native American women are more likely to die from cervical cancer than white women. The HPV vaccine for teenagers and teenage girls, launched in 2007, has also led to global efforts to address the disease in this way.
Several other countries, including Australia and Sweden, have already used screening for cervical cancer.
Teal Health said its self-testing device will start in California next month and then expand. This will be "average risk" for women aged 25-65 years by prescription, through telehealth services. The company said it is working with insurers to provide coverage.