Women's health company Hologic Inc (Nasdaq:HOLX) announced on Wednesday that the US Food and Drug Administration (FDA) has approved its Aptima HPV Assay for clinician-collected HPV primary screening.

The mRNA-based assay is designed to detect infections most likely to lead to cervical cancer.

This new indication expands Hologic's cervical health portfolio to include Pap + HPV co-testing, Pap testing, and HPV primary testing. Approval followed a real-world study of over 650,000 women comparing the Aptima HPV Assay to an FDA-approved DNA-based HPV test, showing comparable sensitivity for detecting CIN2+ and CIN3+.

The expanded approval provides clinicians with greater flexibility in screening strategies, supporting patient-specific approaches based on age, risk factors, and access. Co-testing remains the most comprehensive method, detecting up to 95% of cervical cancers in women aged 30 to 65.

Hologic said that this additional approval for the Aptima HPV Assay follows 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.