SBIR-STTR Award

Historically, tissue sample analysis was limited due to lack of practical high throughput techniques. An advance in tissue analysis came with the invention of the multitumor tissue block. This technology was improved upon, refined and eventually evolvedinto the Tissue Microarray (TMA), currently a key tool in clinical analysis of tissue samples. TMA use involves placement of multiple tissue samples into defined positions within a recipient paraffin block, such that samples can be systematically analyzed. While the TMA represents an improvement, issues of poor sample alignment and quality plague it. Hewitt addressed these limitations with development of templates and methods for preparing TMAs (U.S. patent 7,854,899). In this Phase I project Micatu will implement and improve upon the teachings of U.S. patent 7,854,899 to create a high quality, low cost, Modular TMA. Micatu has developed a TMA design and technical plan that includes alpha deSign and optimization, construction alpha prototypes, pre-pilot design release and manufacture analysis, and pre-pilot prototype construction.

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 H&E stained TMAs featuring 90% alignment of sample cores to the recipient block, 95% sample core perpendicular placement , and 100% compliance to required TMA sectioning count. Micatu's Phase II development program will continue on these successes and rapid progress to provide an affordable, turnkey instrument suite that further expands investigators' 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 30x 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 markets

Public Health Relevance Statement:


Public 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 100 - 500 sections, which can be subjected to immunohistochemistry and fluorescent in situ hybridization.

Project Terms:
Applications Grants; base; Biological Assay; cancer diagnosis; Clinical; clinical application; Clinical Research; commercial application; commercialization; cost; Custom; design; Development; Devices; ergonomics; Fluorescent in Situ Hybridization; Fostering; Freezing; Goals; Health; Heating; Hematoxylin and Eosin Staining Method; Histology; Immunohistochemistry; Injection of therapeutic agent; instrument; laboratory facility; Legal patent; Marketing; Medical; meetings; Methods; Microscope; Microtome - medical device; Molds; Needles; novel; Paraffin; Pathology; Pattern; Performance; Phase; phase 1 study; Plastics; Price; Production; Program Development; programs; prototype; Research; Research Personnel; Resort; Sales; Sampling; Slide; Staining method; Stains; success; System; Technology; Testing; Tissue Microarray; Tissues; tool; Validation;