Validation and commercialization of a/LCI for detection of esophageal neoplasia

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Project Summary The objective of this research is to commercialize a device (the Oncoscope Panocyte" system) used to guide biopsy selection in patients with Barrett's esophagus (BE) during standard endoscopy surveillance for early- stage esophageal cancer. Barrett's esophagus most often develops in patients with chronic acid reflux and is the strongest risk factor for development of esophageal adenocarcinoma. The current standard of care for surveillance, random biopsy guided by white-light endoscopy, is severely limited, since early-stage lesions are not visible during imaging and only a small amount of at-risk tissue can be screened during a single procedure. The Panocyte" system utilizes technology based on angle-resolved low coherence interferometry (a/LCI). It provides a highly sensitive tool for cancer screening through its ability to make quantitative measurements of cellular characteristics, such as nuclear size, that are known to be highly correlated to cancer progression. The non-invasive and real-time nature of the Panocyte" system allows clinicians to examine a greater portion of at-risk tissue, and its ability to selectively probe the basal layer of tissue, where disease first manifests, allows them to detect esophageal cancer in its pre-cancer stages when it is effectively treatable. With these capabilities, using Panocyte" to guide biopsy selection during esophageal endoscopy procedures could ultimately deliver earlier detection via more thorough examination, a reduction in health-care costs by minimizing biopsy of non-dysplastic tissue, and overall improvement in patient outcomes and quality of life. In Phase I of the NIH SBIR program, Oncoscope successfully developed a commercial prototype a/LCI device capable of discriminating between non-dysplastic and dysplastic tissues in a rat Barrett's esophagus model. In Phase II, we expanded on the Phase I work by improving the Panocyte" system design for enhanced commercial and clinical viability, while also demonstrating its clinical operating characteristics in vivo as part of a 175-patient pilot trial. With the following specific aims, our research plan for Phase IIB will build further toward full commercialization by conducting product verification and validation of the esophageal a/LCI clinical system, culminating in the submission of our regulatory application to the FDA for a/LCI-guided excisional biopsy in the esophagus: (1) Finalize product development and perform initial manufacturing and assembly in order to complete design verification of the esophageal a/LCI clinical system, (2) Conduct pivotal clinical trial and user interface study for design validation of using a/LCI to guide excisional biopsy in the esophagus, and (3) Complete manufacturing process validation and design transfer of the esophageal a/LCI clinical system.