HPV Self-Test Kits Could Save Time for Clinicians
December 1, 2025 6 minutes read
By Melinda Young
Human papillomavirus (HPV) causes about 37,800 cases of cancer each year, with cervical cancer and oropharynx cancer being the most common, according to the Centers for Disease Control and Prevention (CDC).1 An estimated 91% of cancers in the cervix are caused by any HPV type. Also, HPV-associated cancers are diagnosed in the vagina, vulva, penis, anus, and oropharynx — the base of the tongue and tonsils.1
While vaccination against HPV can greatly reduce the number of HPV-associated cancer cases, screening for infection also is an important prevention tool. The Food and Drug Administration (FDA) approved two HPV self-collection tests on May 14, 2024. These allow people to collect their own vaginal samples for HPV testing in clinic settings.2 The tests are Onclarity HPV and cobas HPV.2
The next step would be to allow clinicians to prescribe HPV self-tests to patients via telemedicine so they can do this testing in their own homes. A new study looked at the cost-effectiveness of mailed HPV self-sampling and found that mailing HPV kits to individuals was cost-effective for the purpose of cervical cancer screening.3
HPV self-tests have been used in some other countries for about a decade but were only recently approved for use in the United States, says Beverly B. Green, MD, MPH, senior investigator at Kaiser Permanente Washington Health Research Institute, family medicine physician at Kaiser Permanente Washington, both in Seattle. Green also is a professor at Kaiser Permanente Bernard J. Tyson School of Medicine in Pasadena, CA.
Green was a co-author of the randomized clinical trial — the STEP (Self-Testing options in the Era for Primary HPV screening for cervical cancer) — that evaluated multiple ways to reach people and improve HPV testing.3 “We used the HPV self-test kits in our study [early on], and we had to run special FDA tests on equipment to do that,” Green says. “Now, it is FDA-approved, and there’s this great new test, and we showed we have an increase in screening.”
The study found that using HPV self-test kits mailed directly to individuals increases screening rates by roughly 15%. Plus, the self-test kits find about 90% to 93% of HPV-associated cancer cases, she adds.3 “It’s quite a good test,” Green says. “It’s like a COVID test where you swish your nose but instead you swish your vagina.”
The research data showed that people who were overdue for cervical cancer screening had a significantly higher screening rate with the HPV self-test kits, and the same was true for people who were on time for cervical cancer screening rates and used the HPV self-test kits, she adds.3 The HPV self-test kits are ideal to use on a population level because they have very few false negatives: “It either finds [HPV] DNA [deoxyribonucleic acid] or doesn’t,” Green says.
The self-tests do produce a higher level of false positives when screened, but this just means that some people are asked to visit the clinic for further testing when it might not be necessary. Far fewer people have missed HPV findings with the self-test kits than happens with an in-clinic Papanicolaou test (Pap test), she adds.
Pap tests have ranged in sensitivity — the percentage of true-positive cases — of identifying cervical cancer from 55% to 80%. The gold standard screening test is colposcopy with biopsy, according to the National Cancer Institute.4
The new study’s chief finding is that directly mailing HPV kits to screening-adherent and screening-overdue people was economically better than other strategies. Plus, the direct mail program’s delivery costs declined rapidly over four years, suggesting this is an efficient and affordable outreach strategy that health systems could employ.3 “We found in most scenarios that it actually saved money to have patients swab themselves,” Green says. “It was cheaper than doing what we normally do in usual care.” HPV self-testing saves clinician time when the visit would be just to screen for cervical cancer, Green says.
With one exception, the intervention costs of HPV self-test kits had a lower cost basis than other types of HPV screening. Intervention costs were defined by researchers “as the value of resources used to implement the mailed HPV kit program during the trial and were measured from the healthcare system perspective.”3 “In most scenarios, it was cheaper,” Green notes. “There was only the one scenario of a commercial well exam [where the patient] was overdue that was very cheap but not cost-saving.”
About one in four people who were sent the HPV self-test kit in the study used it and returned it, Green says. “It’s a new test and will take a while for people to get it and do it,” she adds.
Investigators divided participants into four groups:
- Usual care, including regularly mailed patient reminders and clinician electronic health record alerts;3
- Direct mail materials with usual care and an HPV self-sampling kit mailed one week later;3
- Education that included usual care plus educational materials and a mailed HPV self-sampling kit one week later,3 or
- Opt-in with usual care and educational materials as well as a toll-free number and website link to request a self-sampling kit, sent one week after the request.3
Participants who were overdue for cervical cancer screening were not randomized to the opt-in group because of international research evidence that direct mail was superior for increasing screening.3 Also, people who had an unknown screening history were not randomized to the direct mail group to limit potential overscreening.3
The study’s findings show the HPV self-test works very well and would be a great screening test for a large population with multiple medical needs, Green notes. “We have an overburdened health system,” she explains. “Primary care access is difficult right now; there are not enough doctors.” This means that most doctors’ schedules are too tight to allow time to have conversations with patients about what is worrying them beyond the reason for the clinic visit, she adds.
“If we can shift the screening of mostly healthy patients [to HPV self-test kits] instead of office visits, that is a win-win,” Green says. “You can take care of the people who are sick [with optimal care], and when patients are worried and need compassion, physicians will have more time for that.”
The HPV self-test kits were sent out by mail after people received a letter that explained what it was and notified them that it would arrive. They could use the self-test kit or come in for a clinic visit for a pelvic exam, she says. “I was involved with interviewing clinicians and site visits, and they reported patients preferred [the kits],” she adds.
“Female clinicians, who do a lot of cervical cancer screening, were very happy to free up some of that time,” Green says. “That was not always true: At least one clinician was worried about missing something by not doing the exam.”
The study’s results suggest that using the HPV self-test as an option for patients to use at home and mail in for results could be a good option from an economic and clinician time perspective, as well as being well-received by some patients, she adds.
“If I was practicing, I would offer it and reassure patients that this was a good test and is something — if they’re comfortable with it — that I’d encourage them to do,” Green says.
Melinda Young has been a healthcare and medical writer for 30 years. She currently writes about contraceptive technology.
References
1. Centers for Disease Control and Prevention. Cancers linked with HPV each year. CDC Cancer. June 11, 2025. https://www.cdc.gov/cancer/hpv/cases.html
2. Reynolds S. FDA approves HPV tests that allow for self-collection in a health care setting. National Cancer Institute. July 24, 2024. https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-hpv-test-self-collection-health-care-setting
3. Meenan RT, Lacey C, Buist DSM, et al. Cost-effectiveness of HPV self-testing options for cervical cancer screening. JAMA Netw Open. 2025;8(10):e2534960.
4. National Cancer Institute. Cervical Cancer Screening (PDQ®) – Health Professional Version. https://www.cancer.gov/types/cervical/hp/cervical-screening-pdq#_115_toc
The Food and Drug Administration (FDA) approved two HPV self-collection tests on May 14, 2024. These allow people to collect their own vaginal samples for HPV testing in clinic settings.
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