The FDA approves the first alternative at home to the smear of the pulp

On Friday, Food and Drug Administration approved the first tool for screening of the United States cervical cancer, which means that it gives women an alternative to slurry smears, which many consider to be painful or traumatic.

The fresh test, performed by the Teal Health, involves erasing the vagina with the lend a hand of a sponge tool instead of inserting a speculative and scraping of cells from the cervix, as the service providers do in the smears of the pulp.

Similar vaginal tests were approved last year for employ in medical offices. But the version at home can lend a hand women who have problems finding, traveling or spending time on a personal meeting.

Approval is the result of a process that began with discovering ten years ago The fact that human papilloma, commonly known as HPV, causes almost all cases of cervical cancer and that people who do not have a virus are practically not risky.

Armed with this information, many suppliers have started testing PAP smear samples for HPV in addition to analysis of cervical cells under a microscope. Some medical organs have shifted to recommend the HPV test as the basic screening method that has opened the door to the vaginal tests, because the virus can be detected in both vaginal and cervical cells.

Uterine cancer experts told the Up-to-date York Times that evidence of testing at home was forceful and studies show that it is as precise as PAP’s conversation.

Turquoise health will allow patients to order an online test, talk to a teeth supplier, collect a sample, and then send it to test HPV. Kara, EGAN, CEO and co -founder of TEAL, said that the company cooperates with insurers to secure insurance and donors to subsidize costs for persons without insurance.

If the test is positive, the patient will be directed to a personal supplier for pap smear or colposcopy to check cancer or foremost changes. (Colorposcopy analyzes the cervix via the magnifying device and allows suppliers to take biopsies.) If the test is negative, no further screening will be needed for three to five years.

TEAL plans to send the initial round of tests to customers in California next month before expanding to other states.

Since the introduction of over 80 years ago, it has been estimated that PAP’s smear prevented hundreds of thousands of deaths due to cervical cancer. In 2006, the HPV vaccine available in the United States became available.

Vaccination and screening cause that cervical cancer can be prevented. And yet he still kills Thousands of Americans Every year, because many women are not or cannot be vaccinated or respondents.

“It is so gloomy to me that cervical cancer is a disease that we could eradicate in our lives,” said Dr. Alexi Wright, director of testing results of gynecological oncology at the Dana-Farber Cancer Institute. “We have tools.

Some people of colorful and country inhabitants may be disproportionately likely that they will lag behind the research, but no group consistently receives it. During the clinical trial, the TEAL asked the participants when they recently received a screening test, and at least one in four women in each group tested – in various races, income, education, location and insurance status – it was already warned.

“This is really a problem that everyone feels,” said Mrs. Egan.

Many women see a gynecologist only when they get pregnant and never for preventive care. A home test can be what warns people at risk of cervical cancer that they have to get to the doctor, said Dr. Sarah Kim, a gynecological surgeon at Memorial Sloan Kettering Cancer Center.

But Dr. Kim said that she did not want patients to perceive HPV tests at home as a wholesale exchange of gynecological tests.

“The place that I see the most applies to people who currently do not see their doctor,” she said.

In December Design of recommendations From the American task group of the American preventive service, they supported independent vaginal tests as an HPV test option, and it was found that HPV tests should be the basic method of testing cervical cancer in 30 and older patients. Task group still recommended PAP division for patients under 30 years of age, but added that independent tests offered another option for people who encounter barriers to the doctor or believe that the fools are uncomfortable.

American Cancer Society’s Recommendations They are a little different, encouraging HPV testing as the basic option from 25.

Dr. Kathy Maclaughlin, a professor of family medicine in Mayo Clinic, who studies screening in the field of cervical cancer, said that more work is needed to provide patients with a positive home test and allow a personal observation supplier, given that no access is the reason why they will probably employ the home test.

“Step 1 is checking more people,” she said, but the solution to the problem of personal access is “an vital step 2 and 3 and 4”