Hologic has received the US Food and Drug Administration (FDA) approval for its Aptima HPV assay for use in clinician-collected primary screening, further expanding its cervical health portfolio.
The human papillomavirus (HPV) test is said to be currently the only FDA-approved messenger RNA (mRNA)-based assay developed to identify infections with the highest risk of leading to cervical cancer.
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With this FDA approval, Hologic now offers three major guideline-recommended methods: Pap testing, HPV primary testing, and Pap + HPV co-testing.
This latest indication follows the clearance of the Genius Digital Diagnostics System with the Genius Cervical AI Algorithm, which utilises digital imaging and AI to support the detection of cytologic abnormalities and precancerous lesions.
Approval was granted after the completion of a real-world HPV screening study involving more than 650,000 women across various US health systems.
The study compared the Aptima HPV assay to an FDA-approved deoxyribonucleic acid (DNA)-based test and found their clinical sensitivity for detecting cervical intraepithelial neoplasia grade two or higher (CIN2+) and cervical intraepithelial neoplasia grade three or higher (CIN3+) to be comparable.
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By GlobalDataHologic diagnostic solutions president Jennifer Schneiders said: “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.
“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.”
In October 2025, Hologic announced the acquisition by alternative asset management entities Blackstone and TPG for up to $18.3bn in enterprise value, according to a definitive agreement.
