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 Conexiant Share Summary Takeaways Listen Insight Report Clinical Scorecard Quiz Poll Top Institutions 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.
