Trial Information

Internet-Based Cervical Cytology Screening Program

This clinical study uses the automated screening capabilities of the FocalPoint Primary
Screening System (BD) for gynecologic cytology specimens (Pap tests) to allow for automated
field of view (FOV) selection, digital image capture, and subsequent Internet-based
transmission to a custom designed computer-based image reading station. The system utilizes
liquid-based cytology preparations (ThinPrep, SurePath). In such a system, no skilled
cytology human resources are necessary at the scanning site, and all expertise can be
centralized. Pilot studies showed that the task was feasible to a clinically relevant
standard of care. Phase 1 trials on preselected and seeded specimens confirmed this
clinical standard. The phase 2 trials extend the concept to a prospectively enrolled
population of patients from 2 sites (Walter Reed, Mass General) thereby testing the concept
in a population of normal disease prevalence. The final phase 3 will be a larger study with
intended use design, siting a screening device at the 121st Army Hospital in Korea and
interpreting the specimen images in the US. In addition to the reading of the specimens,
the system is designed to give immediate "loop closing" results back to each specimen's
originating point immediate upon completion of the test.