SBIR TOPIC 257, INSTRUMENTS AND DEVICES THAT PRESERVE MOLECULAR PROFILES IN TUMO

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Biopsies play an essential role in developing and monitoring of personalized cancer treatments. Current biopsy methods for visceral tumors are ineffective at preserving the molecular profile of the tumor due to the rapid enzymatic reactions that take place during and after the procedure. Our approach is to develop an automated biopsy device that (1) Limits molecular profile degradation by rapidly preserving the biopspecimen, (2) ensures process consistency by automating the steps to obtain and preserve the tumor sample, and (3) provides biomarker assessment flexibility by allowing users to choose cryogenic or chemical preservation. This proposal describes a device concept that utilizes interchangeable cartridges that automatically store and preserve the biopsy sample using either cryogenic or chemical fixative. In this project, we will design and fabricate a prototype device and evaluate its preservation effectiveness by testing it on Rats and SCID mice with a pancreatic cancer cell line model. We plan to use immunohistochemistry, pathology, proteomics, and genomics for evaluating how well the device preserves the molecular profile of the tumor tissue. When successfully completed, the findings of this Phase-1 work will demonstrate the feasibility of our approach and provide the Design Inputs for further developing the device for clinical use.