Molecular medicine holds promise for advancing medical diagnosis and treatment if biomarkers can be accurately assessed in tissues, for example in tumors. The long-term objective of the project is to bring to market new tools for better biopsy tissue acquisition, processing and storing. A first new biopsy device aims to acquire multiple samples into a cartridge and to stabilize the biopsy tissue samples shortly after they are cut, for example by freezing, and thus prevent changes in biomarker levels due to ischemia in the excised tissue samples. A second new biopsy device aims to split the tissue samples into two parts, to store one part in a way that will optimally maintain the histology of the tissue (e.g. formalin fixation) and the second part in a way that will optimally maintain the biomarker levels in the tissue (e.g. freezing). The specific aims of this Phase I project are to develop a prototype core biopsy device for sequential, multiple samples acquisition through a single needle insertion; to develop vacuum-assisted biopsy device with dual- mode preservation for short term storage of the tissue samples; and to compare histology sections and biomarkers qualities as achieved by the prototype biopsy devices versus clinical-grade biopsy device A biopsy methodology that preserves the tissue morphology and stabilizes the biomolecular profile of the cells in the biopsy samples is expected to be used for many clinical and research applications and to achieve wide commercial market. In particular, such a device can be used to monitor the effect of targeted treatment and to improve the management of patients by the use of individualized therapy that targets the specific characteristics of the diseased tissue in each patient.
Public Health Relevance Statement: Narrative The development of new methodology and devices for better acquisition and handling of biopsy tissue samples will facilitate the use of new diagnostic tests and the development of method to adapt and optimize therapy to the individual patient.
Project Terms: Affect; animal tissue; Animals; Applications Grants; Back; base; Biological Markers; Biological Preservation; Biopsy; Biopsy Specimen; Caliber; Cannulas; Cells; Characteristics; Clinical; Clinical Research; cold temperature; Core Biopsy; design; Development; Devices; Diagnosis; Diagnostic Procedure; Diagnostic tests; Dimensions; Disease; Formalin; Freezing; Future; Goals; Harvest; Histology; Immunohistochemistry; improved; In Vitro; in vivo; Individual; individual patient; interest; Ischemia; Laboratories; Medical; Medicine; method development; Methodology; Methods; Microdissection; Molecular Medicine; Molecular Profiling; Monitor; Morphology; Needles; novel diagnostics; Paraffin Embedding; Pathologic; Pathology; Patients; Phase; prevent; Procedures; prototype; Robotics; safety testing; sample collection; sample fixation; Sampling; Small Business Innovation Research Grant; targeted treatment; Time; Tissue Sample; Tissues; tool; tumor; Vacuum; Variant
