Updated federal cervical cancer screening guidelines now include an option for women to self-collect samples at home for high-risk human papillomavirus (hrHPV) testing. According to experts interviewed by Medscape Medical News, this change could expand access while raising new questions about implementation. They emphasized the importance of following up for abnormal results and having the capacity to meet a greater demand for additional testing related to positive HPV results and needed treatment based on findings.
The updated Health Resources and Services Administration guidelines call for:
- Women aged 21-29 years should be screened for cervical cancer using cervical cytology (Pap test) every 3 years. Co-testing with cytology and polymerase chain reaction (PCR)-based hrHPV assays is not recommended for women younger than 30 years. PCR is a laboratory method that identifies specific DNA sequences.
- Women aged 30-65 years should be screened with primary hrHPV testing every 5 years (preferred) or cytology and hrHPV testing (co-testing) every 5 years. If hrHPV testing is not available, continue screening with cytology alone every 3 years.
The Teal Wand at-home kit is currently the only at-home self-collection device approved by the FDA, and it is approved only for use with Roche’s cobas hrHPV test. The cobas test reports HPV 16 and 18 individually and a pooled result for 12 other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). Cytology is not performed on the sample.
Self-collection is intended for women aged 30-65 years at average risk for cervical cancer. It is appropriate only for individuals who are not immunocompromised, do not have a history of high-grade cervical disease, and are undergoing surveillance rather than routine screening. Women who were exposed to diethylstilbestrol (DES) before birth are also considered to be at higher risk. DES is a synthetic form of estrogen that was prescribed until 1971 for pregnant women to prevent miscarriage, premature labor, and related complications of pregnancy.
An important distinction is that the at-home device collects a vaginal sample that is tested for high-risk genotypes known to be associated with cervical cancer, unlike an in-office sample, which is collected from the cervix. A negative result from at-home collection testing allows women to return to routine screening at the recommended interval. Both the American Cancer Society (ACS) and the American Society for Colposcopy and Cervical Pathology (ASCCP) recommend a 3-year interval for at-home self-collection screening.
A positive result with at-home collection does not complete screening. Individuals with a positive hrHPV result are referred to a clinician for further evaluation. In the office, clinicians collect a cervical sample and follow established risk-based management guidelines. Depending on the specific HPV result and available testing platforms, this may include repeat hrHPV testing, cytology, or referral for colposcopy.
Multiple studies have shown that hrHPV testing on self-collected samples has comparable sensitivity and specificity to clinician-collected samples when validated assays are used. In their 2025 editorial, Wentzensen and Baena note, “In cervical cancer screening, HPV testing has higher sensitivity, provides longer reassurance when a test is negative, and has an overall better tradeoff of benefits and harms compared with cytology.”
Recently updated guidelines from the ACS note that the average risk for individuals with a cervix includes those who:
- Are asymptomatic (no abnormal bleeding or “other symptoms concerning cervical cancer for which a more thorough workup is required”); and
- Are undergoing screening for the first time, have a history of all normal cervical cancer screening results in the past, or have a remote history of abnormal results that have been followed by a sufficient amount of normal tests such that the individual fulfills criteria to resume routine cervical cancer screening based on follow-up recommendations from the 2019 ASCCP Risk-Based Management Consensus Guidelines.
Medscape Medical News interviewed three experts to understand how at-home self-collection fits into routine cervical cancer screening. These included Eve Rittenberg, MD, an internist specializing in women’s health; George F. Sawaya, MD, an obstetrician and gynecologist; and Merry Jennifer Markham, MD, a gynecologic oncologist.
Rittenberg is an associate physician within the Division of Women’s Health at Brigham and Women's Hospital in Boston. Sawaya is the director of Zuckerberg San Francisco General Hospital and Trauma Center's cervical dysplasia clinic and a professor of obstetrics and gynecology at the University of California, San Francisco. Markham works at Moffitt Cancer Center in Tampa, Florida.
Medscape Medical News’ questions about self-collection and these experts’ responses to them are below.
What does the option of self-collection add to the guidelines?
Rittenberg: “First, let me emphasize that self-collection is a game changer, with the potential to improve cervical cancer screening and outcomes. Self-collection has the potential to improve cervical cancer screening among patients who lack health insurance and receive care in safety net health systems. A study published in JAMA Internal Medicine in 2025 showed that mailed self-collection was effective for increasing [cervical cancer screening] among underscreened individuals in a safety-net health setting in Texas.
In contrast to clinician-collected cervical cancer screening, self-collected HPV testing can be done at home, typically after a telehealth consultation, in which the individual is screened for eligibility and can discuss the testing and potential follow-up with a clinician. This option — telemedicine combined with home self-collection — is especially helpful for people with challenges accessing in-person care because of transportation barriers or scheduling conflicts.
It’s important to remember that this strategy is not for everyone. In one study, about 70% of women said they preferred self-collection — but this leaves a substantial minority who prefer that the clinician do the exam (Qin 2025).”
What’s the goal of self-collection at home?
Sawaya: “Most people will have a negative test, and they really won’t need to be rescreened for at least 3 years. So, for someone traveling from very far away to just get a speculum exam, and they have access to a test that they could do at home — and if the result is negative — that would make their screening more efficient.”
Markham: “The goal is that if you can expand the population that gets screened, then you can expand the number of people who are being diagnosed, hopefully at an earlier stage and not when the cancer is advanced. As a gynecologic medical oncologist, the patients that I’m seeing coming through my clinics are those that have already had such advanced disease that they’re not candidates for anything other than chemotherapy and radiation. The goal would be for me to never see these patients in my office.”
Who is likely to benefit most from this option?
Markham: “There are still a lot of women who just don’t like going to the gynecologist and having that exam. They’re uncomfortable for some reason. It may be that they have a past history of abuse or some traumatic experience, or they’re just embarrassed. So, this can be great for that population who is anxious or nervous about going through the traditional testing.”
Sawaya: “The big promise for at-home self-collection is to target people who would otherwise not be screened. This is providing access to people who, for various reasons, don’t have access to a high-quality screening program and people who have not been screened or who have not been frequently screened. The thought is that by offering self-collection, we can close that gap by providing access.”
How reliable is self-collection compared to clinician-based screening?
Markham: “There have been a couple of studies that found that self-collection was not inferior to office collection. The sensitivity and specificity are quite similar, indicating that it is appropriate to be included in the updated guidelines.”
Meta-analyses and recent validation studies have found that HPV testing performed on self-collected vaginal samples has comparable sensitivity and specificity to clinician-collected samples, particularly when PCR-based assays are used, such as the cobas assay.
A 2018 meta-analysis showed comparable accuracy for self-collected and clinician-collected samples tested with hrHPV assays (Arbyn 2018). Based on 56 accuracy studies and 25 participation trials, the analysis found PCR hrHPV assays were as sensitive on self-samples as on clinician samples to detect cervical intraepithelial neoplasia (CIN)2+ or CIN3+ (pooled ratio, 0.99; 95% CI, 0.97-1.02).
Insurance coverage is still something of an open question. Currently, the makers of the Teal Wand, Teal Health, state that the at-home kit is available for $99 for patients with certain in-network commercial insurance plans and $249 for self-pay patients. Teal reports that it is in-network with several major commercial insurers.
Who should not use this approach?
Rittenberg: “If a person has a remote history of low-grade abnormal results that have been followed by sufficient amount of normal testing, self-collection may be considered after shared decision-making (Perkins 2026).”
Patients with a history of cervical cancer would be followed through a surveillance protocol and would not be eligible for screening.
What happens after a positive result?
Rittenberg: “All individuals with HPV-positive results [from at-home collection] must undergo prompt follow-up, either for cervical cytology or dual-stain testing or colposcopy. Screening is not considered complete without this follow-up. Treatment then depends on the results of this follow-up.”
What are the hidden downsides to at-home self-collection?
Rittenberg: “It’s important to remember that screening only improves outcomes if there is adequate follow-up for abnormal results. If HPV screening rates increase but resources are not in place to promptly connect people with abnormal results to follow-up testing and treatment, the increased demand could strain existing systems and lead to delays in care. Thus, it is important to have tracking systems and capacity in place to meet the greater demand.
As with any screening test, the benefit of increased screening is accompanied by the potential for unintended harms; these downsides may include anxiety or distress over abnormal results, the potential for false-positive or false-negative results, and harms of treatment related to procedures.
However, I believe that the benefits of offering the option of self-collection greatly outweigh these potential downsides. Allowing individuals the option of choosing between clinician-collected and self-collected screening tests is a patient-centered approach that respects people’s ability to choose the strategy that is right for them.”
Guidelines differ on both the age at which screening should begin and the role of primary HPV testing versus cytology. How should clinicians interpret these differences?
Rittenberg: “The USPSTF [US Preventive Services Task Force] recommends starting cervical cancer screening at age 21, as do ACOG and ASCCP. In their recent updated guidance, the American College of Obstetrics and Gynecology (ACOG) notes that the recommended starting age may increase in the future. However, at present they reaffirm starting at age 21, given current suboptimal rates of cervical cancer screening and HPV vaccination, as well as equity concerns regarding disparities in vaccination rates.
ACS updated their guidelines in 2020 to recommend starting at age 25 rather than age 21. The ACS rationale for beginning routine screening at age 25 is that this age best balances the potential benefits and harms of screening. For the update, they reviewed evidence regarding both of the issues you ask about: potential benefits of reduction in cervical cancer risk and potential harms of overdiagnosis and overtreatment (including risk of preterm birth associated with treatment of precursor lesions). The shift to a later starting age reflects the low disease burden among women younger than 25 years old, the high incidence of transient infections, and the potential for overdiagnosis and overtreatment.”
Sawaya: “It’s really a combination of factors. The ACS put it this way in 2020: ‘On the basis of the consistent low cervical cancer incidence and mortality among women aged less than 25 years, the high incidence of transient infections, the risk of adverse obstetric outcomes of treatment, and the decision analysis demonstrating a favorable benefit-to-harm balance for beginning screening at age 25 years…’ [However], other groups (USPSTF, WPSI [Women’s Preventive Services Initiative], ACOG) still think that age 21 is the appropriate starting age.”
What’s the rationale for co-testing with HPV testing and cytology when primary HPV testing is not available in women?
Sawaya: “Not all HPV tests available in the US are FDA-approved for primary screening (ie, for use as a stand-alone test); thus, they must be paired with cytology for primary screening. We are set up for primary HPV [screening] when collected by a clinician but not for self-collected HPV tests...Our laboratory is not set up to do that yet. I’m not sure when that will happen.”
What remains unknown?
Rittenberg: “It’s important to ensure that increases in screening do not lead to a decreased emphasis on the importance of HPV vaccination. HPV vaccination remains a crucial and effective strategy to prevent cervical cancer and other HPV-associated cancers.”
Sawaya: Although most meta-analyses have shown comparable performance for PCR-based assays, there are questions about small differences in sensitivity and limited long-term data that have led to more conservative rescreening recommendations.
“Some of the evidence shows that these self-collected tests are somewhat less sensitive [than clinician-collected samples], meaning they might be more likely to miss precancer or even a cancer. That has given some people pause. As a matter of fact, the American Society for Colposcopy and Cervical Pathology (ASCCP) has recommended a shorter rescreening interval. For people who have a negative test, [ASCCP] doesn't explicitly state that the test is less sensitive; they say there isn’t a lot of data on longer-term outcomes for patients screened with self-collected at-home tests. So, there’s a bit of a safety net that ASCCP is invoking, and the American Cancer Society has echoed this with a 3-year screening interval for the self-collected test versus a 5-year interval if a clinician collects the sample.”
Rittenberg and Markham reported having no relevant disclosures. Sawaya was a co-author of Qin’s 2025 article.
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