MARLBOROUGH, Mass. — Hologic, Inc. (Nasdaq: HOLX) announced that the U.S. Food and Drug Administration (FDA) has approved its Aptima® HPV Assay for use in clinician-collected primary screening for cervical cancer. The assay is now part of a broader range of FDA-approved testing options offered by Hologic, further expanding the company’s cervical health portfolio.
The Aptima HPV Assay is the only FDA-approved human papillomavirus test based on mRNA technology. It is designed to identify high-risk HPV infections most likely to lead to cervical cancer, offering an alternative to DNA-based HPV tests currently on the market.
“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, Ph.D., President of Diagnostic Solutions at Hologic. “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.”
The expanded approval positions the Aptima HPV Assay alongside Hologic’s existing options for cervical screening, including Pap testing and co-testing (Pap + HPV). Together, these three modalities align with guideline-recommended practices and give healthcare providers the ability to tailor screening strategies based on individual patient risk, access to care, and clinical needs.
The FDA approval was supported by one of the largest real-world studies of its kind, involving more than 650,000 women across diverse U.S. healthcare systems. The study compared the performance of the Aptima HPV Assay to that of an FDA-approved DNA-based HPV test and demonstrated comparable sensitivity for detecting high-grade cervical lesions, including CIN2+ and CIN3+.
This approval follows Hologic’s recent clearance of its Genius® Digital Diagnostics System with the Genius® Cervical AI Algorithm, which uses advanced imaging and artificial intelligence to aid in detecting cytologic abnormalities and precancerous changes.
Cervical cancer screening remains a vital tool in women’s health. In 2026, an estimated 13,490 new cases of invasive cervical cancer are expected in the United States, with approximately 4,200 related deaths. However, many of these outcomes are preventable with regular screening and timely follow-up of abnormal results.
While co-testing remains the most comprehensive method — with studies showing up to 95% of cervical cancers detected and high provider confidence in women ages 30 to 65 — Hologic’s full range of options enables providers to align their testing approach with each patient’s specific needs.
