Hologic Receives FDA Approval for Aptima HPV Assay Primary Screening Option

Hologic has received FDA approval for its Aptima HPV Assay for clinician-collected HPV primary screening. This expands the company's cervical health portfolio, which now includes Pap + HPV, Pap testing, and HPV primary testing. The Aptima HPV Assay is the only FDA-approved mRNA-based assay for HPV primary screening, designed to detect infections likely to lead to cervical cancer. The approval follows a real-world evidence study involving over 650,000 women across diverse health systems.