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A New Era in Cervical Cancer Screening: Women Can Now Self-Collect for HPV

The FDA’s approval of HPV self-collection kits in May 2024 marks a significant advancement in cervical cancer screening, offering women in the United States more accessible and less invasive options for early detection. As reported by U.S. News, this development allows women to collect their own vaginal samples for HPV testing, potentially increasing screening rates and improving early detection of cervical cancer.

FDA-Approved HPV Self-Tests

FDA.
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In May 2024, the FDA approved two groundbreaking HPV self-collection solutions for use in clinical settings:

  • Roche cobas HPV Test: Allows vaginal self-sampling in various healthcare environments, detecting 14 high-risk HPV strains, including types 16 and 18 linked to 70% of cervical cancers.
  • BD Onclarity HPV Assay: The first FDA-approved test with extended genotyping capabilities for self-collected samples, aimed at individuals facing barriers to traditional pelvic exams.

These approvals represent a significant step towards addressing disparities in cervical cancer screening, as over 50% of U.S. cervical cancer cases occur in under-screened populations. The self-collection option empowers women who may have difficulty accessing traditional screening methods due to mobility challenges, cultural preferences, or trauma history.

At-Home HPV Test Kits

HPV.
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While the FDA has not yet approved fully at-home HPV testing, several companies offer mail-in kits that use self-collected vaginal swabs analyzed in CLIA-certified labs. These options include:

  • Everlywell HPV Test ($49): Screens for 14 high-risk HPV strains with results in 5-7 days, providing physician-reviewed reports and HIPAA-compliant results.
  • myLAB Box At-Home HPV Test ($79 with code Testing20): Offers the fastest turnaround time of 2-5 days and includes free physician consultations for positive results.1
  • Nurx Home HPV Test Kit ($79 or $49 with insurance): Provides telehealth support and detailed instructional videos to guide users through the self-collection process.2

These kits are marketed as screening tools rather than diagnostic tests, bypassing the need for FDA approval. However, health authorities emphasize that positive results require follow-up clinical evaluation to ensure proper care and management.

Future Innovations in HPV Testing

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Teal Health’s Teal Wand, which received FDA breakthrough designation in May 2024, represents a promising advancement in at-home HPV testing. This speculum-free collection device could enable fully remote screening once clinical trial data is submitted and approved.

Concurrently, the National Cancer Institute’s SHIP Trial, part of the “Last Mile” initiative, is evaluating home-based self-collection to support future FDA approvals. In the healthcare sector, Mayo Clinic plans to offer FDA-approved self-collection at its Midwest locations starting February 2025, with plans for national expansion thereafter. These developments signal a shift towards more accessible and patient-friendly cervical cancer screening methods.

Updated Cervical Screening Guidelines

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In December 2024, the U.S. Preventive Services Task Force (USPSTF) endorsed HPV self-collection for individuals aged 30-65, citing equivalent accuracy to clinician-collected samples. 

The updated guidelines recommend:

  • Ages 25-29: Pap test every 3 years
  • Ages 30-65: HPV test every 5 years (self- or clinician-collected) or co-testing (Pap + HPV)

These new recommendations aim to increase screening accessibility and reduce barriers to cervical cancer prevention, potentially saving lives by detecting precancerous changes earlier.

Insurance Coverage for HPV Self-Testing

worried thinking woman.
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Insurance coverage for HPV self-testing in the United States has expanded in recent years, making these innovative screening methods more accessible to many individuals. Medicare Part B covers HPV testing as part of cervical cancer screening once every 5 years for people aged 30-65 without HPV symptoms. This coverage applies to both clinician-collected and self-collected samples, as long as the test is FDA-approved and performed in a healthcare setting.

Private insurance plans are required to cover cervical cancer screenings, including HPV tests, for individuals with a cervix aged 21-65 without copay, as mandated by the Affordable Care Act. While coverage for at-home HPV test kits may vary, the increasing recognition of self-collection as a valid screening method is likely to lead to broader insurance coverage in the future. Patients should consult their insurance providers for specific coverage details, as policies may differ between plans.

Medicaid and HPV Testing

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Medicaid coverage for HPV testing as part of cervical cancer screening varies by state, but most state Medicaid programs do cover basic screening for cervical cancerFor individuals who qualify for Medicaid through the Affordable Care Act expansion, cervical cancer screening services are covered as essential preventive care. However, for those who qualify through traditional Medicaid pathways, coverage is considered “optional” and determined by each state.

The majority of state Medicaid plans follow the 2018 U.S. Preventive Services Task Force recommendations, which include coverage for primary HPV screening. As of 2024, most state Medicaid plans cover HPV vaccination for adults aged 27 to 45 years, which should assist healthcare providers in recommending vaccination to high-risk adults. However, coverage for newer screening methods like HPV self-collection kits may still be limited, and patients should check with their state’s Medicaid office for specific coverage details.

Future of Cervical Screening

worried woman.
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HPV self-collection represents a significant advancement in cervical cancer screening, offering increased accessibility and potential for higher participation rates. Studies have shown that mailed HPV self-collection kits can significantly improve screening uptake among underscreened populations, with one randomized controlled trial reporting a 1.95 times higher screening rate compared to usual care. 

While current FDA approvals limit self-collection to healthcare settings in the USA, the future looks promising for at-home testing options. As research continues and guidelines evolve, HPV self-collection has the potential to reduce barriers to screening access, increase early detection of cervical abnormalities, and ultimately save lives by improving cervical cancer prevention efforts. 

The Freckle That Turned Out to Be Vulvar Cancer: Would you know the signs?

Doctor or dietitian speaking with female patient.
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Scrolling through TikTok as one does, a video came across my FYP or “for you page” – it was a woman talking about the fact that she just found out that this tiny freckle on her vulva turned out to be vulvar cancer. She was now devastated and terrified and facing surgery. She was bravely sharing her personal story, as so many thankfully do on TikTok, to offer information that might save someone else’s life.

READ: The Freckle That Turned Out to Be Vulvar Cancer: Would you know the signs?

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  • Robin Jaffin headshot circle

    As the co-founder and managing partner of the digital media partnership Shift Works Partners, LLC through two online media brands, FODMAP Everyday® and The Queen Zone she has played a pivotal role in promoting dietary solutions for individuals with specific needs in the health and wellness industry as well as amplify the voices and experiences of women worldwide.

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