IGF::OT::IGF SBIR PHASE I TOPIC 331: DEVELOPMENT OF A BIOSENSOR-BASED CORE NEEDLE TUMOR BIOPSY DEVICE

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A low-cost disposable device and a handheld battery-powered instrument will be developed. The device can be inserted into a biopsy needle and will identify whether the needle tip is in an optimal tumor area prior to biopsy by sensing multiple tissue parameters including tissue structural and electrochemical changes. These parameters in tumor tissue have been proven to be significantly different from those in normal tissue. The instrument will display real time curves of the parameters, and give audio indications when they exceed the preset thresholds. Tissue flow, elasticity, and pressure information will be innovatively detected by a single ultrasound transducer mounted at the tip of the device. The transducer will be composed of the advanced single crystal composite and will have high sensitivity and wide bandwidth. It will be used for Doppler flow detection for the first time. Two biocompatible needle shape electrodes mounted at the device tip, sharing a common reference electrode, will be used to detect the electrochemistry parameters. With multiple parameters, the device will enhance the biopsy success by sampling high tumor content areas. Collection of high quality tumor biopsies with sufficient material for biomarker profiling is essential for full implementation of precision medicine for cancer patients.