FDA Expands HPV Primary Screening Options
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February 4, 2026
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2 min
The FDA has approved an expanded indication for Hologic's Aptima HPV assay, allowing for primary human papillomavirus screening. This new approval introduces an alternative to existing Pap testing methods, targeting messenger RNA to identify infections likely to cause cervical cancer. With around 13,490 new invasive cervical cancer cases expected in the U.S. in 2026, the assay offers a critical tool in prevention, backed by a study of over 650,000 women. Hologic provides all three major FDA-approved cervical cancer screening options, supporting healthcare providers in their decision-making based on patient needs.
1. FDA expands approval for the Aptima HPV assay for primary screening.2. The assay targets messenger RNA to identify high-risk infections.3. Approximately 13,490 new cervical cancer cases expected in 2026.4. Study involved over 650,000 women, demonstrating comparable sensitivity.5. Hologic offers three recommended cervical cancer screening strategies.6. Co-testing detects up to 95% of cervical cancers.7. Providers show high confidence in screening for women aged 30-65.
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