Hologic's Aptima HPV Assay Receives FDA Approval for Primary Cervical Cancer Screening
Key Insights
Hologic's Aptima HPV Assay (search) received FDA approval for clinician-collected HPV (search) primary screening, marking the only FDA-approved mRNA-based assay designed to detect infections most likely to lead to cervical cancer (search).
The approval was supported by one of the largest real-world evidence HPV (search) screening studies involving over 650,000 women across multiple U.S. health systems, demonstrating clinical comparability to DNA-based HPV tests.
The expanded approval provides healthcare providers with three major FDA-approved cervical cancer (search) screening options: Pap + HPV (search) co-testing, Pap testing, and HPV primary testing.
Hologic announced that its Aptima HPV Assay (search) received FDA approval for clinician-collected HPV (search) primary screening, expanding the company's cervical cancer (search) screening portfolio. The mRNA-based assay represents the only FDA-approved test of its kind, specifically designed to detect human papillomavirus (search) infections most likely to progress to cervical cancer.
The approval addresses a critical public health need, as approximately 13,490 new cases of invasive cervical cancer (search) are expected to be diagnosed in the United States in 2026, with about 4,200 women projected to die from the disease. However, many of these deaths are preventable through regular screening and appropriate follow-up on abnormal results.
Clinical Evidence Supporting Approval
The FDA approval was supported by one of the largest real-world evidence HPV (search) screening studies conducted to date, involving over 650,000 women across multiple U.S. health systems. The study reflected diverse, real-life patient populations and clinical settings, comparing the Aptima HPV Assay (search) to an FDA-approved DNA-based HPV test for primary screening.
The study findings demonstrated that the sensitivity of the Aptima HPV Assay (search) is clinically comparable to the comparator test. The assay proved effective for primary screening in detecting CIN2+ (search) and CIN3+ (search) lesions, which represent precancerous changes that can progress to invasive cervical cancer (search).
Comprehensive Screening Portfolio
The additional indication for the Aptima HPV Assay (search) expands Hologic's offerings to include three major FDA-approved and guideline-recommended methods for cervical cancer (search) screening: Pap + HPV (search) co-testing, Pap testing, and HPV primary testing. This comprehensive approach provides healthcare providers with greater flexibility in selecting screening approaches based on patient age, access, and risk factors.
"Hologic has been at the forefront of cervical cancer (search) screening for decades, and the additional indication of the Aptima HPV Assay (search) 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. "By offering providers more choice and flexibility, we can help them deliver the most personalized care for each patient."
Co-testing Remains Gold Standard
While the new approval provides additional screening options, co-testing continues to demonstrate superior performance. More than 90% of providers report strong confidence in co-testing for women ages 30 to 65, with data showing that co-testing (Pap + HPV (search)) detected up to 95% of cervical cancers, making it the most comprehensive screening modality available.
Technology Integration
The Aptima HPV Assay (search) approval follows the recent clearance of Hologic's Genius Digital Diagnostics System (search) with the Genius Cervical AI Algorithm (search). This system leverages advanced digital imaging and artificial intelligence to help detect cytologic abnormalities and precancerous lesions, representing the first and only FDA-cleared digital cytology system.
Hologic's cervical health portfolio includes several industry-first innovations: the ThinPrep Pap Test (search) as the first liquid-based cytology test, the Aptima HPV Assay (search) as the first and only approved mRNA-based HPV (search) test, and the Genius Digital Diagnostics System (search) as the first FDA-cleared digital cytology system. These technologies support both cytology and molecular workflows from sample collection to results, designed to assist clinicians and laboratory professionals in cervical cancer (search) detection and prevention.