FDA Expands HPV Primary Screening Options - Takeaways - MDSpire

FDA Expands HPV Primary Screening Options

Regulatory action broadens available approaches for cervical cancer screening in US clinical practice.

  • By

  • Kathryn Wighton

  • February 4, 2026

  • 2 min

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  • 1

    The FDA approved the Aptima HPV assay for primary HPV screening, expanding options beyond Pap testing and co-testing.

  • 2

    The Aptima HPV assay detects messenger RNA, making it the only FDA-approved HPV test targeting RNA instead of DNA.

  • 3

    An estimated 13,490 new invasive cervical cancer cases are expected in the US in 2026, with 4,200 deaths potentially preventable through screening.

  • 4

    A large study involving over 650,000 women showed the Aptima HPV assay's sensitivity is comparable to DNA-based HPV tests.

  • 5

    Hologic's testing options allow providers to choose screening methods based on patient age, access, and risk factors.

Original Source(s)

FDA Expands HPV Primary Screening Options

  • by Kathryn Wighton

  • February 4, 2026

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