Hologic, a women’s health diagnostics company, has received US Food and Drug Administration (FDA) approval for its Aptima HPV assay for use in clinician-collected primary cervical cancer screening. The Aptima test is the only FDA-approved mRNA-based HPV assay designed to detect infections most likely to progress to cervical cancer.

Cervical cancer screening remains a critical component of preventive healthcare. In 2026, an estimated 13,490 new cases of invasive cervical cancer are expected to be diagnosed in the United States, with around 4,200 related deaths. Health experts note that most of these deaths can be prevented through regular screening and timely follow-up of abnormal results.

Jennifer Schneiders, President of Diagnostic Solutions, Hologic, said, “Hologic has been at the forefront of cervical cancer screening for decades, and the additional indication of the Aptima human papillomavirus assay reflects our ongoing commitment to advancing women’s health through innovative, evidence-based solutions. 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 personalised care for each patient.”

The approval is supported by HPV screening studies conducted in the United States, involving more than 650,000 women across multiple health systems. The study compared the Aptima mRNA-based assay with an FDA-approved DNA-based HPV test and found comparable clinical sensitivity for detecting CIN2 plus and CIN3 plus lesions.