The Food and Drug Administration (FDA) has approved two new self-collection tests for human papillomavirus (HPV), which means people with a cervix can now collect their own vaginal swab samples at urgent care, mobile clinics, or in a healthcare provider’s office.

The new tests—cobas HPV, made by biotechnology company Roche, and Onclarity HPV from medical technology firm BD—were approved by the FDA on May 14. But these tests could be available in healthcare providers’ offices as early as this fall, company spokespeople told the New York Times.

These self-administered swabs are an alternative to more traditional HPV testing, which is usually done in tandem with a Pap test, also called a Pap smear. During these cervical cancer screenings, doctors usually insert a speculum in the vagina to access the cervix, which can be painful or uncomfortable.

But being able to self-administer an HPV test should expand access to cervical cancer screening and provide a more convenient and private option for women.

“A lot of patients hesitate to make an appointment with a gynecologist due to them potentially being intimidated with the pelvic exam,” Cielo Gnecco, MD, an OB-GYN at Orlando Health Women’s Institute, told Health. “If there is a self-collect option, these patients may be more likely to be more compliant with cervical cancer screening.”

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HPV is a commonly transmitted sexual infection, and most people will be infected at some point in their lives. Usually, people’s immune system clears the virus from the body. However, when the virus isn’t cleared from the body, it can lead to a persistent infection that causes cervical cancer.

Screening tests—typically a Pap smear—check for HPV or other signs of cervical cancer and are necessary for early diagnosis and treatment. If caught early, cervical cancer is treatable.

Despite this, the percentage of women who are overdue for recommended cervical cancer screening is rising.

There are a number of ways in which the healthcare system makes it challenging for people to get regular Pap smears, routine gynecological exams, and sexually transmitted infection (STI) screening, said Sheryl Ross, MD, an OB-GYN at Providence Saint John’s Health Center. Long wait times, lack of health insurance, and financial constraints may dissuade people from seeking care.

However, “self-collection [tests put] the control of healthcare with the patients, which is beneficial, empowering, and ultimately lifesaving,” Ross told Health.

These newly-approved HPV tests might also be a better option for people who avoid cervical cancer screenings due to past traumatic experiences, including a history of sexual violence.

“Some patients have never had a pelvic exam or a Pap smear in their lifetimes,” Diana Pearre, MD, a gynecologic oncologist at the Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center, told Health.

“That pelvic exam is the one thing preventing them from seeing a gynecologist,” she said. “This test could give them another option for collection in a way that prioritizes their autonomy and privacy.”

Self-collection for HPV testing is a first step in identifying risk for cervical cancer, but that doesn’t necessarily mean Pap tests and pelvic exams will go by the wayside.

Instead, if someone tests positive for HPV on one of these new tests, they may want to discuss getting a Pap smear or additional cervical cancer screening with their healthcare provider, Ross said.

During a Pap smear, a healthcare provider will use a small brush to remove cells from the cervix surface. These cells are examined under a microscope and examined for abnormal or cancerous cells.

Beyond this, though, these in-person appointments usually include a pelvic exam, where the healthcare provider can check the vagina, vulva, uterus, ovaries, and cervix for any abnormalities. Physical exams can also help doctors spot vaginal or vulvar precancers, as well as other cervical, uterine, or ovarian issues, Pearre said.

Self-collection tests need to be accurate and able to detect what they’re indicated to detect before even receiving FDA approval. But there are many things that these tests simply cannot pick up, she explained.

“Although this test can be more convenient for some patients, as a gynecologist, I will still recommend a pelvic exam to ensure there are no other anomalies present,” Gnecco agreed.

Whether you test positive or negative, Ross said a conversation about personal risk factors for cervical and other related cancers should occur with a healthcare provider to determine how often you should have a Pap smear alongside any separate testing for HPV.

“Testing for HPV should never replace the accuracy of medical testing done by a healthcare provider, nor discourage going to your healthcare provider for persistent symptoms or going annually for routine gynecologic care,” said Ross.

The American Cancer Society recommends that cervical cancer screening start at age 25 for anyone with a cervix. How often you require in-person exams depends on age, risk factors, and other health factors, including whether you’ve had a hysterectomy.

For now, the FDA’s approval of the cobas HPV and Onclarity HPV tests means people with a cervix can self-collect for HPV in a clinical setting. And this broader access could mean more change on the horizon soon—Americans could soon see approval of at-home collection tests for HPV.

The FDA recently granted “breakthrough device status” to a new home cervical screening device called Teal Wand by Teal Health. This elevated status can fast-track approval processes, meaning the device could be on the market sooner than later.

In theory, this means patients could “get and interpret results themselves, or be able to send in a test to a laboratory for interpretation,” explained Pearre.

But even if these at-home tests do one day gain FDA approval, Gnecco said it’s still “vital” that patients have a routine annual exam with their provider. These appointments offer opportunities to ask questions, pose concerns, and discuss health maintenance and screening recommendations.

“Nothing replaces seeing a healthcare provider regularly, and not just for HPV and Pap smear testing, but for other important conversations related to STIs, birth control counseling, irregular periods, mental health screening, sexual problems, and other issues commonly experienced by women that only healthcare providers can conduct with their patients,” said Ross.



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