You Can Now Self-Test for HPV: What to Know About the First FDA-Approved Tests
Key takeaways:
Human papillomavirus (HPV) is a sexually transmitted virus that’s responsible for causing almost all cases of cervical cancer.
People with a cervix aged 21 to 65 should get tested for HPV and cervical cancer on a regular basis.
The FDA approved a self-test so you can easily test yourself, in a healthcare setting.
It has now become easier to test for human papillomavirus (HPV), a virus that can spread through sexual contact. HPV is a very common virus. But it’s important to test for because some strains of this virus can cause cancer.
The good news is that you don’t always need a pelvic exam to get tested. In May 2024, the FDA approved the first tests for HPV that you can do yourself in a healthcare setting. The tests are accurate and easy to administer.
Here’s what you need to know.
HPV and cancer
Most people get exposed to HPV at some point in their lives. Often, there are no signs or symptoms. Sometimes, HPV causes genital warts. But in 9 out of 10 people with HPV, the immune system fights off the virus within about 2 years.
Still, experts recommend that you get screened for HPV. That’s because some strains of this virus can lead to cancer. HPV can pass from person to person through different types of sex: oral, anal, and vaginal. So, HPV-related cancer can develop in your:
Cervix
Anus
Vulva
Vagina
Throat
HPV is the cause of almost all cases of cervical and anal cancer. And it’s responsible for most cases of cancer of the vagina and vulva. Each year in the U.S., nearly 22,000 women have a cancer diagnosis related to HPV. Yet more than half of people with cervical cancer in the U.S. have never been screened or don’t get screened often enough for HPV.
The FDA approved the new self-test to help make HPV testing more available. The goal is to reduce cervical cancer and other cancers related to HPV.
Can you do a self-test for other STIs? Yes, there are some sexually transmitted infections you can test for at home.
How can I get vaccinated against HPV? Here’s what you need to know about the human papillomavirus (HPV) vaccine.
Does HPV cause genital warts? Yes, some but not all strains of HPV can cause genital warts.
Who should test for HPV?
If you’re between 21 and 29 years old, you should get screened for cervical cancer with a Pap test (or Pap smear). In this test, your cervix is swabbed by a healthcare professional. The cells are sent to a lab to look for HPV as well as precancerous cells and cancer cells.
If you’re between 30 and 65 years old, you should choose one of the following options:
HPV testing once every 5 years
Pap test alone once every 3 years
Both a Pap and HPV test every 5 years
HPV testing without a Pap test is also an option for some people starting at 25 years old.
Self-testing for HPV may be right for you if you’re not due for a Pap test or pelvic exam. Or it can be helpful if it’s hard to find a healthcare professional who can do a pelvic exam or Pap test. Self-testing kits also may be easier to access at a healthcare setting.
How HPV self-testing works
The FDA’s approval of a self-test makes it easier for you to test for HPV. The self-test allows you to swab your vagina and collect a testing sample yourself. There’s no need for a pelvic exam — or for a healthcare professional to use a speculum and swab your cervix. And the self-test works just as well to detect HPV. But unlike a PAP test, it can’t show early signs of cervical cancer.
You have to do the self-test in a healthcare setting. Contact a healthcare professional and request an appointment to do the self-test: The tests are already available.
Or you can ask your healthcare professional for a prescription for the self-test. Then you can take the test to a lab or a participating retail pharmacy with a private area set up for this purpose.
The on-site healthcare professional will:
Give you the supplies you need
Instruct you on how to collect the sample from your vagina
Give you the privacy to do it
When you’re done, your sample will be sent to the lab, and you’ll be told how to get your results.
You can have confidence in the test. When done correctly, results from a swab you perform yourself are just as accurate as tests performed by healthcare professionals to detect HPV. The lab uses the same diagnostic tools as those used for many years on swabs taken professionally.
Keep in mind, though, that these tests won’t show whether or not you have cervical cancer.
What HPV strains do self-collection kits test for?
With the sample you collect from your vagina, the lab can test for 14 different types of HPV that are high risk for causing cancer.
When to talk to your doctor
If your test results show that you have HPV, you’ll need to talk to your healthcare professional. They’ll go over the next steps with you. For example, they’ll help you know when it’s time to get a PAP test or colposcopy to make sure you don’t have signs of cervical cancer.
The most important thing is to do the test so you can catch potential cancer-causing HPV early.
Frequently asked questions
No, FDA-approved HPV tests are not available for home use. You can do it yourself in a healthcare setting or pharmacy that offers it. You may have a home-test option in the future, though: The FDA is reviewing a different HPV self-test for home use.
Home tests are available, but they aren’t approved by the FDA and they may be less accurate.
Yes. There are many types of HPV. The types that cause cancer are different from the types that cause genital warts.
Yes, you can get a vaccine to prevent HPV and HPV-related cancer. It’s available to all people aged 11 to 45.
It’s still best to test for HPV even if you’ve been vaccinated. Talk to your healthcare professional about how to get the HPV vaccine.
The bottom line
Most people get HPV at some point in their lives. Most times, it goes away without any problem. But it’s important to get tested for HPV to learn if you have the type that could cause cancer. The FDA has approved a new test that you can do yourself in a healthcare setting. The benefit is that you collect a sample from your vagina yourself, in private, and don’t need to have a pelvic exam. Self-tests are available with a prescription or at the offices of healthcare professionals.
Why trust our experts?
References
American College of Obstetrician and Gynecologists. (2024). Updated cervical cancer screening guidelines.
Arbyn, M., et al. (n.d.). HPV testing on self-samples: The evidence of today. HPV World.
Arbyn, M., et al. (2022). Meta-analysis of agreement/concordance statistics in studies comparing self- vs clinician-collected samples for HPV testing in cervical cancer screening. International Journal of Cancer.
Centers for Disease Control and Prevention. (2022). Cancers caused by HPV.
Centers for Disease Control and Prevention. (2023). Basic information about HPV and cancer.
Centers for Disease Control and Prevention. (2024). About genital HPV infection.
Premarket Approval (PMA). (2024). Device: BD Onclarity HPV assay. U.S. Food and Drug Administration.
Premarket Approval (PMA). (2024). Device: Cobas HPV for use on the Cobas 6800/8800 systems. U.S. Food and Drug Administration.
Sahasrabuddhe, V., et al. (n.d.). Addressing a ‘last mile’ problem in cervical cancer screening. National Cancer Institute.
Teal Health. (2024). Teal Health completes clinical trial at record speed and receives FDA breakthrough designation for its at-home cervical cancer screening device, the Teal Wand.
U.S. Food and Drug Administration. (2024). FDA roundup: May 17, 2024.
