The Food and Drug Administration approved the first home range for cervical cancer on Friday on Friday, a decision that gives women an accessible alternative to smears that many find painful or traumatic.
The New Test, made by green -blue health, means that the vagina with a sponge -like tool instead of placing a speculum and scraping cells from the cervix, such as doctors do in smears.
Similar vaginal tests were approved last year for use in medical offices. But the home version can help women who have difficulty finding, traveling or making time for a personal appointment.
The approval is the result of a process that started with the discovery decades ago That the human papillomavirus, generally known as HPV, causes almost all cases of cervical cancer and that people who do not have the virus are virtually no risk.
Armed with that information, many doctors started testing smear samples for HPV in addition to analyzing cervical cells under a microscope. Some medical authorities shifted to recommend HPV tests as the primary screening method, which opened the door for vaginal tests, because the virus can be detected in both vaginal and cervical cells.
Experts from cervical cancer told the New York Times that the evidence for testing was strong at home and studies show that it is about as accurate as smears.
Teal Health enables patients to order the test online, to talk with a TeleHealth doctor, collect a sample and then email to be tested on HPV. Kara Egan, the Chief Executive and co-founder of Teal, said that the company collaborated with insurers to guarantee coverage and with donors to try to subsidize the costs for people without insurance.
If the test is positive, the patient will be referred to a personal provider for a smear or colposcopy to check for cancer or precancere cell changes. (A colposcopy examines the cervix through a magnifying device and enables doctors to take biopsy.) If the test is negative, no further screening is required for three to five years.
Teal is planning to email a first test round to customers in California next month before they expand to other states.
Since the introduction More than 80 years ago, it is estimated that the porridge has prevented hundreds of thousands of deaths due to cervical cancer. And in 2006 a vaccine against HPV became available in the United States.
Vaccination and screening make cervical cancer. And yet it still kills Thousands of Americans Every year, because many women cannot or cannot be vaccinated or screened.
“The thing that is so sad for me is that cervical cancer is a disease that we can eradicate in our lives,” said Dr. Alexi Wright, the director of gynecological oncology outcomes research at the Dana-Farber Cancer Institute. “We have the tools to do it. We just don’t have an extensive HPV vaccination or screening for cervix cancer and often cannot reach the people who are at the highest risk.”
Some people of color and residents in the countryside may probably fall back on screening, but no group will receive it consistently. During the clinical examination of Teal, participants asked when they last received a screening, and at least one in four women in each group investigated – in the breed, income, education, location and insurance status – was over.
“This is really a problem that everyone felt,” said Mrs. Egan.
Many women only see a gynecologist when they become pregnant and never for preventive care. A home test could be the thing that warns those who risk cervical cancer they need to go to a doctor, Dr. Sarah Kim, a gynecological surgeon in Memorial Sloan Kettering Cancer Center.
But Dr. Kim said she didn’t want patients at home to see HPV tests as a wholesale replacement for gynecological exams.
“The place that I see most applicable is for people who don’t see their doctor at the moment,” she said.
In December, Design recommendations From the American preventive services, Task Force itself undergone collected vaginal tests as an option for HPV tests, and said that HPV tests should be the primary screening method for cervical cancer for patients from 30 years and older. The Task Force continued to recommend smears for patients younger than 30, but added that self-ravaged tests offered another option for people who are confronted with barriers who come to the doctor or find porridge outings uncomfortable.
The American Cancer Society’s recommendations are a little different and penetrate HPV tests as the primary option from 25.
Dr. Kathy Maclaughlin, a associate professor of general practitioner medicine at the Mayo Clinic who studies screening on cervical cancer, said that more work was needed to ensure that patients with a positive home test could find a personal provider and can afford for a follow-up, since they are a reason for a lack of access.
“Step 1 is to show more people,” she said, but solving the problem of personal access is “the important steps 2 and 3 and 4.”
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