Pharma innovator Hologic has announced that its Aptima HPV Assay has received FDA approval for clinician-collected HPV primary screening, marking a significant advance in women’s health. The test is the only FDA-approved mRNA-based HPV assay, specifically designed to detect infections most likely to lead to cervical cancer.
Cervical cancer screening remains critical: in 2026, an estimated 13,490 new cases of invasive cervical cancer are expected in the U.S., with about 4,200 women dying from the disease. Many of these deaths are preventable with regular screening and timely follow-up.
“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, 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 new FDA clearance expands Hologic’s offerings to include Pap + HPV (co-testing), Pap testing, and HPV primary testing — three major, guideline-recommended methods for cervical cancer screening.
This milestone follows the recent clearance of the Genius Digital Diagnostics System with the Genius Cervical AI Algorithm, which uses advanced digital imaging and AI to detect cytologic abnormalities and precancerous lesions.
The approval is backed by one of the largest real-world HPV screening studies ever conducted, involving over 650,000 women across diverse U.S. health systems. The study found that the Aptima HPV Assay’s sensitivity is clinically comparable to an FDA-approved DNA-based HPV test for primary screening, proving effective in detecting CIN2+ and CIN3+ lesions.
While co-testing remains the most comprehensive screening method — with over 90% of providers confident in its use for women ages 30 to 65, and data showing it detects up to 95% of cervical cancers — Hologic emphasizes that its full range of testing options gives providers greater flexibility to tailor screening to patient age, risk factors, and access.
