Hologic Received FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio
On February 04, 2026, Hologic, Inc. announced that its Aptima® HPV Assay had received FDA approval for clinician-collected HPV primary screening. The test, which was the only FDA-approved mRNA-based assay at the time, had been specifically designed to detect infections most likely to lead to cervical cancer.
Screening for cervical cancer has been critically important for women’s health. In the United States, it was estimated that in 2026, around 13,490 new cases of invasive cervical cancer would be diagnosed, and approximately 4,200 women would die from the disease. Many of these deaths, however, could have been prevented with regular screening and appropriate follow-up on abnormal results. Timely follow-up had been essential for early detection and treatment, helping to reduce both cervical cancer cases and mortality.
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The additional indication for the Aptima HPV Assay expanded Hologic’s portfolio to include Pap + HPV co-testing, Pap testing, and HPV primary testing, three major FDA-approved and guideline-recommended methods for cervical cancer screening. This approval followed clearance of the Genius® Digital Diagnostics System and the Genius® Cervical AI Algorithm, which use advanced digital imaging and artificial intelligence to aid in the detection of cytologic abnormalities and precancerous lesions.
The approval came after the completion of one of the largest real-world evidence HPV screening studies, which involved over 650,000 women across multiple U.S. health systems and reflected diverse patient populations and clinical settings. This study compared the Aptima HPV Assay with an FDA-approved DNA-based HPV test for primary screening and found that the Aptima HPV Assay’s sensitivity was clinically comparable to that of the comparator test. It was shown to be effective for primary screening to detect CIN2+ and CIN3+.
Although co-testing had remained the most comprehensive screening method with over 90% of providers reporting high confidence for women aged 30 to 65, and data showing that Pap + HPV co-testing detected up to 95% of cervical cancers Hologic’s expanded range of testing options had provided providers with greater flexibility to choose an approach based on a patient’s age, access, and risk factors.
“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.”
According to DelveInsight’s “Molecular Diagnostics Market Report,” the molecular diagnostics market was valued at USD 9.56 billion in 2024 and is projected to grow at a CAGR of 9.21% from 2025 to 2032, reaching USD 16.12 billion by 2032. The molecular diagnostics market is experiencing significant growth due to the increasing cases of infectious diseases, including HIV, Hepatitis B, Hepatitis C, Influenza, and human papillomavirus (HPV). The introduction of new and innovative products by key Molecular Diagnostics Companies, among others, is expected to drive the Molecular Diagnostics Market from 2025 to 2032.
Source: https://www.delveinsight.com/blog/medtech-news-for-hologic-zoll-labcorp