Develop & Validate An Ultrasound Tissue Preservation De*

DESCRIPTION (provided by applicant): The primary goal of Bio-Quick is to provide a vehicle to transform the innovative biotechnology available in research labs from Armed Forces Institute of Pathology into marketable and profitable medical instruments that can greatly benefit the health care, food market safety control, and the advancement in medical community. Formalin-fixation and paraffin-embedding (FFPE) is a time-consuming but standard tissue preservation and processing method used in over 90 percent cases in hospitals and clinical settings for routine histology diagnosis. Our proposed project is to design and develop an ultrasound-facilitated processor (DTP) for rapid tissue fixation and processing for histology diagnosis and any further molecular study if necessary. The implementation of the technique will allow a significant reduction in processing time from at least 24 hours by conventional FFPE to less than 1 hour. We also need funding to support collaboration with outside and independent researchers to provide objective evaluation of the technique. Our specific aims of this SBIR phase I project are: 1) Development of a commercialized intensity adjustable bench top fixer/processor for rapid formalin fixation and paraffin embedding, 2) Evaluate and validate the DTP method in comparison to conventional FFPE method based on preservation of morphological details and molecular analyses. During the past 7 years, we have compared the DTP method with conventional FFPE method on over 100 human tissue specimens of 14 tissue types. Our preliminary data have demonstrated that compared to conventional FFPE, US-facilitated FFPE not only significantly reduces the total fixation/processing time from over 24 hours to within 1 hour, but also preserves similar or better tissue morphology, much improved protein antigen properties and mRNA integrity. As a results of improved preservation of macromolecules, antigen retrieval treatment prior to IHC staining may be reduced, much reduced (20X or more) antibody concentration and shortened IHC reaction time are used. Long-term stability of tissue morphology and mRNA integrity in USFFPE tissues is slightly better than that in conventional FFPE tissues.