MICATU INC. — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTION provided by applicant The objective for the Phase I study was to design and build a low cost Tissue Microarray TMA device that would meet market demands for high quality fast TMA construction To that end Micatu Inc has successfully developed a production ready TMA device and kit MicaArray that has successfully demonstrated Handamp E stained TMAs featuring alignment of sample cores to the recipient block sample core perpendicular placement and compliance to required TMA sectioning count Micatuandapos s Phase II development program will continue on these successes and rapid progress to provide an affordable turnkey instrument suite that further expands investigatorsandapos ability to construct their own TMAs without resorting to expensive core laboratory facilities as well as allow for the efficient reliable and low cost construction of TMAs for validation and use in research and clinical settings This will foster a proliferation of applications in fields such as pathology histology IHC controls and cancer diagnosis having major medical impact The MicaArray vision represents a simple yet powerful concept based on seamless integration precision fabrication and optimization of tools for constructing TMAs The Phase II research plan will refine the novel alignment template that registers and guides the coring needle at highly precise intervals design and build a novel ergonomic and versatile coring and injection needle with a threaded needle system that allows for a single handle for both extraction of the donor block cores and injection into recipient block prove out with design verification testing a low cost rugged construction of the MicaArray device using machinable or injection molded plastic for volume production and manufacturability provide a custom low cost mold for casting TMA blocks design build and install an integrated Thermoelectric Cooler TEC Heater that can directly heat and cool donor and recipient blocks thereby providing a new powerful and heretofore unavailable capability to electronically control and devise thermal cycling sequences that are optimum for both paraffin and cryo frozen embedded TMA construction and commercialize the MicaArray kit at a sales price that is x less than any commercially available instrument Key words to identify the research or technology Tissue microarray staining paraffin cryo recipient block donor block template Coring Needle TMA Brief summary of the potential commercial applications of the research Micatu Inc research plan provides commercialization potential to the academic clinical and research marketsPUBLIC HEALTH RELEVANCE The objective of this Phase II grant application is to commercialize a simplified low cost tissue microarray instrument for use in clinical and research settings to help validate the immunohistochemical assays for cancer diagnosis Tissue cores are inserted in a recipient paraffin block in a precisely spaced array pattern Sections from this block are cut using a microtome mounted on a microscope slide and then analyzed by any method of standard histological analysis Each microarray block can be cut into sections which can be subjected to immunohistochemistry and fluorescent in situ hybridization