Falog toe Pap at home approved by the FDA: Sarcelle Health

PAP smear are dreaded and uncomfortable tasks at the Ob-Gyn office. These are also rescue procedures.

A new DIY test in the shape of a Sarcelle health buffer aims to make the most important part of your PAP smear – Water cancer screening – a little more comfortable and private. On Friday, the United States Food and Drug Administration approved the cervical cancer test at Teal’s house, the first of its kind in the United States.

The new test cannot completely replace pelvic examinations, but it could help fill the gap in the cervical cancer screening. In the United States, around one in four women is late on their FRIF PAPs for various reasons, including a lack of access.

“It’s just a new way to collect the sample, it’s not a new test,” Kara Egan, CEO of Teal Health told Business Insider. “You can really eliminate cervical cancer in the United States, if we really screen.”

A tampon for cancer screening

Teal’s test screens for the human papillomavirus (HPV), which is the virus which causes more than 99% of the cervical cancer cases.

The device is designed as a stamp, with a plastic applicator that guides a spongy and spongy point that deploys and collects a sample inside the vagina. By testing more than 600 women in 16 clinical trial sites nationwide, Teal found that 98% of users obtain a specific test result on their first trial, and 94% of participants preferred that it is his test in a doctor’s office.

Once the results have been sent by post and treated, Teal asks patients to plan a follow -up of follow -up with one of its suppliers to discuss their results.

“Any method that can really bring screening to patients and overcome some of the obstacles that prevent women from obtaining appropriate screening will be exciting and important,” a genetics and a personalized cancer prevention program in Weill Cornell in New York.

Although an HPV test is not the only component of a PAP smear, Frey said it was the “most important” test.

Home tests still can’t do everything.

“Overall, I am very favorable to the new screening methods that help meet patients where they are,” said Dr. Rachel Flink-Bochacki, an academic ob-gyn in New York. “My only hesitation is that there are so many other things that happen during a health care visit, so many other advantages, even just for a routine smear.”

A desktop smear can detect other less common cancers than HPV screening would not pick up. During a pelvic examination, a doctor can also notice other concerns such as warts or abnormal veins, and may identify signs of endometriosis, fibroids, skin problems, abnormal masses or infection.

It is sensitive to the fact that many women avoid staying up to date on pelvic exams and PAP smear, sometimes because of a past sex trauma. For this reason, she says that some of her patients collect their own HPV test samples in her office during their visit.

“For someone who cannot or who is not comfortable accessing gynecological care, a test that allows you to have an impact screening,” said Flink-Bochacki.

Mortal but preventable cancer

In the 1940s, cervical cancer was a cause of women’s cancer death in the United States. With the widespread adoption of the Froops PAP in the 1940s, then the first vaccine against HPV in 2006, affairs and deaths have decreased sharply. There are still disparities in which is detected and treated, minorities and women living in rural areas are often late.

“After seeing these patients, although there are not many, each of them is a really significant loss,” said Frey. “It is often very young women who are otherwise in good health and who should have had a normal lifespan.”

With a vaccination generalized by HPV, as well as adequate screening for cancer, it is possible to essentially prevent cervical cancer. In Australia, Home tests from the HPV, associated with a vaccination generalized by the HPV, have the country on the right track to end the cervical cancer as a public health problem by 2035, according to COUNCIL NSW cancer.

In regions of the world where screening and vaccination against HPV is not as accessible, cervical cancer is still a major concern and a main cause of cancer death for women. According to the American Cancer Society, cervical cancer is still deadly cancer for women in 37 countries in the world.

The cervical cancer testing test at Teal’s house will be available for patients in California from June. The company says it will be covered by major health insurers, including Aetna, Cigna and Anthem Blue Cross Blue Shield. There will also be a cash payment option, with details that will be announced in the coming weeks.

“Before the end of the year, you will see us to other states,” said Egan.