The US Food and Drug Administration expanded Hologic’s Aptima HPV assay indication to include clinician‑collected primary HPV screening, adding flexibility for cervical cancer screening strategies. The clearance enlarges Hologic’s portfolio across Pap/HPV co‑testing and primary HPV sampling and supports broader adoption of molecular HPV testing in line with guideline options. Hologic called the approval a women’s‑health milestone and emphasized interoperability with its digital cytology platforms. The decision gives providers three major guideline‑recommended modalities — Pap + HPV co‑testing, Pap alone, and HPV primary testing — and may shift procurement and screening algorithms in primary care and gynecology settings. Payers and health systems will reassess screening workflows and reimbursement pathways; diagnostic makers and labs are likely to accelerate deployment of molecular screening options to capture screening volume and meet evolving preventive care standards.