Hologic Receives FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio
- Expanded FDA approval across multiple cervical cancer screening modalities supports clinical flexibility and provider choice
Hologic, Inc. announced today that its Aptima® HPV Assay received FDA approval for clinician-collected HPV primary screening. Hologic’s human papillomavirus (HPV) test is the only FDA-approved mRNA-based assay, designed specifically to detect infections most likely to lead to cervical cancer.
Screening for cervical cancer is critically important to women’s health. In the United States, it is estimated that in 2026, approximately 13,490 new cases of invasive cervical cancer will be diagnosed, and about 4,200 women will die from the disease.1 However, many of these deaths are preventable with regular screening and appropriate follow-up on abnormal results. Timely follow-up is essential for early detection and treatment to reduce cervical cancer cases and deaths.1
“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 additional indication for the Aptima HPV Assay expands Hologic’s offerings to now include Pap + HPV (co-testing), Pap testing, and HPV primary testing — three major FDA-approved and guideline-recommended methods for cervical cancer screening. This additional approval for the Aptima HPV Assay follows the clearance of the Genius® Digital Diagnostics System with the Genius® Cervical AI Algorithm, which leverages advanced digital imaging and artificial intelligence to help detect cytologic abnormalities and precancerous lesions.
The approval comes following the completion of one of the largest real-world evidence HPV screening studies, involving over 650,000 women across multiple U.S. health systems that reflect diverse, real-life patient populations and clinical settings. This innovative study compared the Aptima HPV Assay to an FDA-approved DNA-based HPV test for primary screening and found that the sensitivity of the Aptima HPV Assay is clinically comparable to the comparator test. The Aptima HPV Assay is effective for use in primary screening for the detection of CIN2+ and CIN3+.
While co-testing remains the most comprehensive screening modality — with more than 90% of providers reporting strong confidence for women ages 30 to 65, and data showing that co-testing (Pap + HPV) detected up to 95% of cervical cancers — Hologic’s range of testing options gives providers greater flexibility in selecting an approach based on a patient’s age, access and risk factors.2-5
About Hologic’s Cervical Health Solutions
Hologic offers a broad portfolio for cervical cancer screening, supporting both cytology and molecular workflows from sample collection to results. The portfolio includes innovations such as the ThinPrep® Pap Test, the first liquid-based cytology test, the Aptima HPV Assay, the first and only approved mRNA-based HPV tests, and the Genius Digital Diagnostics System, the first and only FDA-cleared digital cytology system. These technologies are designed to support clinicians and laboratory professionals in the detection and prevention of cervical cancer, all backed by Hologic’s support and partnership.
About Hologic, Inc.
Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world.
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