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.
