SPECTROSCOPIC DIAGNOSTIC FOR BARRETTS DYSPLASIA

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Newton Laboratories, Inc. (NLI) will design a prototype instrument for use by gastroenterologists performing endoscopic surveillance of patients with Barrett's esophagus (BE). The instrument will identify dysplastic changes in real-time using an innovative spectroscopic technique called Light Scattering Spectroscopy (LSS). LSS Measures the size distribution and density of cell nuclei in the surface of esophageal mucosa by analyzing light scattered from those nuclei. A recent clinical study has shown that LSS can accurately detect both high grade and low grade dysplasia in patients with BE. The instrument used in this study was a laboratory device designed to test the scientific principle in a clinical setting. In this Phase I program, NLI will design a clinical instrument, to be constructed and clinically tested in Phase II, which is easy to use and commercially practical. The instrument will incorporate improved methods for removing the background and extracting the clinical information, so that information can he provided in an automated fashion in real time. The new design will be tested on tissue phantoms to establish that it meets performance goals. If successful, this project will lead to an important new tool for routine use by gastroenterologists for detecting and diagnosing this serious condition. PROPOSED COMMERCIAL APPLICATIONS: The LSS technique has significant advantages over current biopsy- dependent surveillance methods, It is minimally invasive, provides diagnoses in real-time, allows a much greater number of sites to be sampled and has proven to he highly reliable in its initial clinical trials, compared to both the average and consensus diagnoses of pathologists. As such it will find a ready market in hospitals and clinics which perform these surveillance procedures.