OM1 Supports 650,000 Patient Real-World Regulatory Submission for FDA Approval of Hologic's Aptima HPV Assay

Massive study demonstrates how AI-enabled evidence generation can meet the FDA's bar for decision-making

BOSTON--(BUSINESS WIRE)--OM1, a real-world evidence generation company and the leading AI outcomes platform, presented its role in the landmark study that supported FDA approval of Hologic's Aptima HPV Assay for primary cervical cancer screening at the Medical Device Innovation Consortium Evidence Summit on May 5, 2026. The approval, announced by Hologic in February 2026, followed one of the largest real-world evidence studies ever conducted for an FDA submission — spanning more than 650,000 women across multiple U.S. health systems.

Data automation was central to the study from data acquisition and quality control through reporting. The company's platform ingested data from electronic health records and laboratory information systems from participating centers, de-identified, tokenized and mapped data at scale and used AI and machine learning to extract key variables from unstructured clinical notes, cytology reports, and pathology records. The study participated in the NESTcc (National Evaluation System for health Technology Coordinating Center) program, a structured process for assessing real-world evidence for medical devices.

"Two characteristics really defined this study," said Rich Gliklich, Founder of OM1. "One is the scale — 650,000 patients is large by any measure. The second is that a lot of the key variables lived in the unstructured data, the clinical notes and reports." Gliklich noted that the platform's automation capabilities were central to making a study of this scale feasible: "The site Net Promoter Score averaged 87.5 — which is off the charts, and that probably reflects how much manual effort was reduced with automation."

The study required processing unstructured clinical data at a volume that traditional manual abstraction methods can not support. OM1's platform automated quality control, surfaced real-time reporting dashboards for site investigators, and maintained full traceability and provenance of data throughout the process. All AI and machine learning models used for natural language processing of clinical documents were rigorously validated and documented to support regulatory review.

The approval marks a significant implementation case for real-world evidence in regulatory submissions. Studies of this scale have historically been constrained by the cost and time required for manual data collection and abstraction. OM1's platform approach demonstrates that automation, when paired with rigorous validation, can reduce those constraints without compromising data quality.

About OM1

OM1 is pioneering cutting-edge healthcare innovation through its insights-driven technology and data. It specializes in clinical registries, evidence generation, and real-world evidence (RWE) research powered by a next-generation AI platform, deep longitudinal data, and globally recognized thought leadership. OM1 is led by a diverse group of scientists, engineers, researchers, and clinicians with over 30 years of experience in RWE. Learn more at OM1.com.