The FDA approves the HPV test at home to detect cervical cancer

Friday, Food and Drug Administration approved the first home test to detect cervical cancer, said the test kit.

Currently, screening for cervical cancer is in a doctor's office during a pelvic examination, a process that some women find uncomfortable and even painful.

Some patients are not detected for cervical cancer because they do not want a pelvic exam, said Dr. Emeline Aviki, a gynecological oncologist at Nyu Langone Health.

“This is not a fun examination and it is the simplest thing to cancel,” said Aviki, who worked on some of the first studies to validate the new test.

Col of the cervix is ​​considered highly avoidable, thanks to projections and the vaccine against HPV. The rates of the disease have dropped since the 1970s, according to a 2025 American Cancer Society reportAlthough they have started to level in recent years. The report estimated that this year, 13,360 women will receive a diagnosis of cervical cancer and that around 4,320 women will die.

However, the number of women who translate into screening have fallen since the mid -2000s. A 2022 study found that 23% of women were late on their cervical cancer screening in 2019, compared to 14% in 2005. Up to half of women diagnosed with cervical cancer in the United States were not up to date on their projections, the American Cancer Society says.

“Screening of cervical cancer in general is something that saves lives,” said Dr. Jessica Kiley, head of the general obstetrics and gynecology in Northwestern Medicine in Chicago.

The new test, called Sarcelle wand, detects the HPV using vaginal calibration, making it less invasive than a PAP smear, in which the gynecologist inserts a speculum and collects samples of cervical cells.

HUMV, or human papillomavirus, is a sexually transmitted infection and the main cause of cervical cancer. There is no treatment for HPV, but most of the cases are clear alone. However, several strains are linked to cervical cancer.

The Sarcelle wand is not the first HPV test which uses a vaginal sample: last year, the FDA approved a similar storage, also carried out by patients themselves, that is to say collected in a doctor's office.

“What is different in this new indication is that this sample can be taken home and not in a medical environment,” said Dr. George Sawaya, gynecologist at UCSF Health. “You must logically believe that it would increase access if the main barrier of people was to go to a medical framework.”

A recent report in Jama Network Open have found that women in rural areas are 25% more likely to be diagnosed with cervical cancer and 42% more likely to die of the disease than women living in cities, a trend that probably reflects lower access to screening and care in rural regions of the country.

Patients will be able to order the test kit after a remote manary with a doctor, then collect the sample themselves at home. For the moment, the product must be prescribed by one of the virtual suppliers of Teal Health, but the company plans to make it available to other doctors. The assessor is then sent to a laboratory for analysis.

Teal Health said that if the result is positive, his providers will help organize additional care. After a positive test, women may need additional tests in a doctor's office.

However, experts want more information on the cost of the test and if patients follow if they need more tests.

“These are some of the uncertainties around him,” said Sawaya.

Kara Egan, CEO of Teal Health, did not say how much the test would cost.

However, she said, because screening for cervical cancer is approved by a government group called US Preventive Services Task Force, the company provides that the test will be covered by insurance and plans to know definitively in the coming months. In December, the working group approved self-giving through the office in a recommendation project.

Kiley, Northwestern’s gynecologist, said it’s still important that women regularly see a gynecologist. An annual examination covers more than just screening for cervical cancer, she said.