FDA approves Aptima HPV assay for clinician-collected primary cervical cancer screening

The FDA has granted approval for Hologic’s Aptima HPV Assay as a clinician-collected primary screening test for cervical cancer, marking a regulatory expansion beyond its prior adjunct and reflex indications.¹

This decision adds to the array of FDA-authorized high-risk human papillomavirus (hrHPV) assays that may be used as stand-alone primary screening in average-risk women, aligning with evolving practice patterns that increasingly endorse HPV-based detection strategies over cytology-only approaches for cervical cancer prevention.²

Primary HPV screening—testing for high-risk HPV infection without concurrent cytology—is supported by US Preventive Services Task Force (USPSTF) recommendations as an effective strategy to detect cervical precancer and cancer, reduce lifetime screening frequency, and streamline follow-up management.³ Regular cervical cancer screening with hrHPV tests has been shown to improve detection of high-grade cervical intraepithelial neoplasia (CIN2+) relative to cytology alone, with acceptable specificity.³

Regulatory and study overview

The FDA approval expands the indication for the Aptima HPV Assay to include clinician-collected HPV primary screening, based on data from a large real-world evidence screening study.¹ The multicenter analysis reportedly included more than 650000 women across diverse US health systems and compared the assay with an FDA-approved DNA-based hrHPV test for the identification of clinically meaningful cervical disease endpoints (CIN2+ and CIN3+).¹ According to the sponsor’s announcement, the sensitivity of the Aptima assay was “clinically comparable” to that of the comparator HPV test, although full data have not yet been published in peer-reviewed literature.¹

Mechanism and historical context

The Aptima HPV Assay detects E6/E7 messenger RNA (mRNA) from 14 high-risk HPV types associated with cervical carcinogenesis, in contrast to most other FDA-approved assays that detect viral DNA.¹^,⁴ E6/E7 transcript detection is hypothesized to reflect biologically active infection more likely to lead to precancerous lesions, potentially improving specificity without compromising sensitivity, although longitudinal comparative data remain limited.⁴ Prior to this primary screening indication, the Aptima assay had FDA approval for reflex testing after atypical cytology (eg, ASC-US) and for use adjunctive to cytology in women 30 years or older.⁵

International validation studies and meta-analyses have generally supported comparable or slightly higher specificity for Aptima relative to DNA assays with similar cross-sectional sensitivity for CIN2+ detection, meeting established performance criteria for HPV tests.⁴^,⁵ However, longitudinal outcomes such as long-term negative predictive value equivalent to established DNA tests are less well characterized.⁴

Clinical context and guidelines

Cervical cancer remains a significant public health issue in the United States, with an estimated 13490 new invasive cases and 4200 deaths projected in 2026.¹ Vaccination against oncogenic HPV types and regular screening have dramatically reduced incidence and mortality, but gaps in screening persist, especially among underscreened populations. Guidelines from the USPSTF and professional societies (eg, ACOG, ASCCP) now include primary hrHPV testing every 5 years for women aged 30 to 65 years or co-testing every 5 years, with cytology alone every 3 years acceptable in younger women.^1,3,6

WATCH: Barbara Levy, MD: Patient-collected hrHPV testing is "huge" part of updated cervical cancer guideline

Primary HPV testing as an approach may reduce the number of lifetime screening tests and is recognized for comparable detection of cervical precancer compared with co-testing, although integrated cytology retains a role in certain populations and follow-up processes.³

References:

1. Hologic Receives FDA Approval for Aptima HPV Assay Primary Screening Option. Hologic Inc. News release. Hologic. Feb 4, 2026. Accessed February 4, 2026. https://investors.hologic.com/press-releases/press-release-details/2026/Hologic-Receives-FDA-Approval-for-Aptima-HPV-Assay-Primary-Screening-Option-Expanding-Cervical-Health-Portfolio/default.aspx.
2. US Preventive Services Task Force. Cervical Cancer: Screening. USPSTF Draft Recommendation. Accessed February 4, 2026. https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/cervical-cancer-screening-adults-adolescents
3. Aetna Clinical Policy Bulletin: Cervical Cancer Screening and Diagnosis. Accessed February 4, 2026. https://www.aetna.com/cpb/medical/data/400_499/0443.html
4. Heideman DAM, Hesselink AT, van Kemenade FJ, et al. The Aptima HPV assay fulfills the cross-sectional clinical and reproducibility criteria of international guidelines for human papillomavirus test requirements for cervical screening. J Clin Microbiol. 2013;51(11):3653-3657. doi:10.1128/JCM.01517-13
5. FDA approves Aptima HPV assay for use on Hologic’s Panther System. Hologic Inc. News release. Hologic. July 23, 2013. Accessed February 4, 2026. https://investors.hologic.com/press-releases/press-release-details/2013/FDA-Approves-Aptima-HPV-Assay-For-Use-on-Hologics-Panther-System/default.aspx
6. Harper DM, Bettcher CM, Young AP. It is time to switch to primary HPV screening for cervical cancer. Am Fam Physician. 2024;109(1):8-9