FDA Expands HPV Primary Screening Options

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

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The FDA approved the Aptima HPV assay for primary HPV screening, expanding options beyond Pap testing and co-testing.
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The Aptima HPV assay detects messenger RNA, making it the only FDA-approved HPV test targeting RNA instead of DNA.
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An estimated 13,490 new invasive cervical cancer cases are expected in the US in 2026, with 4,200 deaths potentially preventable through screening.
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A large study involving over 650,000 women showed the Aptima HPV assay's sensitivity is comparable to DNA-based HPV tests.
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Hologic's testing options allow providers to choose screening methods based on patient age, access, and risk factors.

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