FDA Clears At-Home HPV Screening Tool - Takeaways - MDSpire

FDA Clears At-Home HPV Screening Tool

Self-collection approach aims to expand screening access

  • By

  • Kathryn Wighton

  • April 8, 2026

  • 2 min

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  • 1

    The FDA has cleared the Onclarity HPV self-collection kit for at-home cervical cancer screening.

  • 2

    Cervical cancer is largely preventable through routine screening and early identification of HPV.

  • 3

    Approximately 60% of cervical cancer cases occur in unscreened or under-screened patients.

  • 4

    The BD Onclarity HPV Assay detects high-risk genotypes and provides extended genotyping results.

  • 5

    The self-collection kit will be available by prescription and is expected to be covered by insurance.

Original Source(s)

FDA Clears At-Home HPV Screening Tool

  • by Kathryn Wighton

  • April 8, 2026

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