A tissue microarray (TMA) is an important technique used by pathologists to accurately analyze tissue samples. It is a means of aggregating tissue samples in an organized grid fashion for high throughput analysis. Automated TMAs are commercially available, but they are expensive ($16,000-$230,000) and require specialized training and experience to apply the technology. This recently transferred technology from the National Cancer Institute (NCI) addresses the high instrumentation cost and specialized training barriers of existing commercial tissue microarrays, and offers a simplified, manual, low-cost tissue alternative for use in clinical and research settings to validate the immunohistochemical (IHC) assays for cancer diagnosis.

The NCI team was led by Dr. Stephen Hewitt, a research pathologist who first conceived this invention in response to his observation that the community needed a simpler and more affordable instrument for the discovery and validation of biomarkers to ultimately improve cancer research and diagnosis. Once patented, the NCI Technology Transfer Center identified that the advancement of the technology could be well-served by the Small Business Innovation Research Technology Transfer (SBIR-TT) program, and subsequently recommended it as one of the first NCI technologies for the program. The technology was released as a contract topic for the SBIR-TT and was awarded to a small company, Micatu, Inc. Micatu completed Phase I of the award, and was later awarded Phase II grant funding in June 2014.

The transfer of this NCI technology highlights the use of the SBIR-TT mechanism to transform a patented NCI invention into a commercialized product. The commercialization of this instrument provides researchers and pathology laboratories with access to a technology that was not previously accessible because of technical complexity and significant cost. From Dr. Hewitt’s original 2003 drawing, a high-quality, precision instrument with functional and speed capabilities rivaling automated instruments that cost from 8 to 30 times as much is being realized. The “Microarray,” likened to a “histology lab in a box,” operates without power, making it accessible in the field. Through the vision of Dr. Hewitt and the engineering know-how of Micatu, the result of this technology transfer is an affordable, turnkey instrument that gives investigators the ability to construct their own TMAs rather than having to go to a core service laboratory. 

Awardees

NIH - National Cancer Institute 

• Dr. Stephen Hewitt
• Dr. Greg Evans
• April Franks
• Dr. John Hewes

NIH - Office of Technology Transfer

• Tedd Fenn