FDA Expands Approval of Aptima HPV Assay for Cervical Cancer Primary Screening

The FDA has expanded the approval of Hologic’s Aptima human papillomavirus (HPV) assay for clinician-collected primary screening. ¹ This milestone positions the assay as a cornerstone in the evolving landscape of cervical cancer prevention, offering a highly specific, messenger RNA (mRNA)-based alternative to traditional DNA-based methodologies.

For clinicians, this approval represents more than just an additional tool; it signals a shift toward precision diagnostics that focus on identifying the infections most likely to lead to oncogenic progression.

The paradigm of cervical cancer screening is shifting away from cytology-only models toward HPV primary screening. This approach prioritizes the detection of the high-risk HPV as the initial step in the screening algorithm. With this expanded FDA approval, Hologic now provides a comprehensive suite of screening options—including co-testing (Pap and HPV), Pap testing alone, and now, HPV primary screening.²

This versatility allows healthcare providers to personalize patient care based on individual risk factors, age-specific guidelines, and clinical access, ensuring that screening programs are both effective and adaptable.

Technical Differentiation: The mRNA Advantage

The Aptima HPV assay represents a distinct technological departure from the DNA-based tests that have historically dominated the market. While DNA tests identify the presence of the viral genome—which may represent a transient infection that the immune system would otherwise clear—the Aptima assay targets E6/E7 mRNA.¹

By targeting the expression of E6 and E7 oncoproteins, the Aptima assay specifically identifies infections that have reached a stage of active cellular transformation. This specificity is crucial in reducing "over-diagnosis" and the subsequent over-treatment of transient infections, which can lead to unnecessary patient anxiety and invasive follow-up procedures.

Clinical Validation and Real-World Evidence

This approval is supported by real-world evidence studies in the field, involving more than 650,000 patients.¹ The findings confirm that Aptima's sensitivity is clinically comparable to traditional DNA-based HPV tests.

Data were gathered across multiple US health systems, ensuring that the results reflect real-life clinical settings rather than a narrow, controlled trial environment.

The assay has proven highly effective in detecting high-grade lesions, specifically cervical intraepithelial neoplasia (CIN)2+ and CIN3+which are the critical precursors to invasive cervical cancer.³

Integrating Aptima Into Clinical Practice

For the clinical community, the integration of mRNA-based primary screening offers a path toward higher diagnostic value. By focusing on the molecular drivers of malignancy, clinicians can more accurately triage patients and manage resources effectively.

“Hologic has been at the forefront of cervical cancer screening for decades, and the additional indication of the Aptima HPV Assay reflects our ongoing commitment to advancing women’s health through innovative, evidence-based solutions,” said Jennifer Schneiders, PhD, president of Diagnostic Solutions at Hologic, in a news release. “Our commitment to providing comprehensive cervical health solutions that meet provider and patient needs is unwavering, and by offering providers more choice and flexibility, we can help them deliver the most personalized care for each patient.”

REFERENCES

1.Hologic receives FDA approval for Aptima HPV assay primary screening option, expanding cervical health portfolio. News release. Hologic. February 4, 2026. https://tinyurl.com/bdfaedz

2.Hologic announces first and only FDA-cleared digital cytology system – Genius digital diagnostics system. News release. Hologic. Published February 1, 2024. Accessed February 4, 2026. https://tinyurl.com/5n6ce4ja

3.Haedicke J, Iftner T. A review of the clinical performance of the Aptima HPV assay. J Clin Virol. 2016;76:S40-S48. doi:10.1016/j.jcv.2015.10.027