OTHER FUNCTIONS DEVELOPMENT OF TOOLS FOR CRYOGENIC BIOPSY OF SOFT TISSUE.

Robin Medical, Inc., Baltimore MD

Investigators

Abstract

Molecular medicine holds promise for advancing cancer diagnosis and treatment if biomarkers can be accurately assessed in tumors. The objective of the project is to develop and test a new biopsy system that stabilizes the target tissue and prevents changes in biomarker levels due to ischemia in the excised tissue sample. The specific aims of the project are: 1. Design and build a clinic-ready, stand-alone cryobiopsy device 2. Develop and validate an assay for assessing molecular biomarker preservation 3. Design and conduct studies of the device in xenograft model 4. Conduct a pilot clinical study of the device in selected human tumors 5. Initiate the process to achieve FDA clearance of the device A biopsy device that preserves the tissue morphology and stabilizes the biomolecular profile of the cells in the sample is expected to find a wide market and many clinical and research applications. In particular, such a device can be used to monitor the effect of specifically-targeted treatment and to improve the management of patients by the use of individualized therapy that targets the specific characteristics of the tumor in each patient.