The University of Minnesota has finalized a license agreement with Flagship Biosciences for software that provides quantitative analyses of protein expression levels in human tissue samples. The software, IHC Map, improves a pathologist’s ability to characterize diseased tissues and assists researchers with clinical trials for pharmaceuticals and medical devices.
The exclusive license agreement for the university-developed software has also forged a partnership between BioNet, a central tissue procurement and research histology lab on the university’s Twin Cities campus, and Flagship Biosciences, a private company based in Flagstaff, Ariz.
Flagship performs histopathology services for biotech, pharmaceutical, medical device and cosmetic companies. Flagship offers IHC Map to its customers and also refers organizations to BioNet for additional tissue procurement and research services that it does not offer.
“Flagship provides digital pathology services, primarily to the pharmaceutical industry,” said Dr. Steve Schmechel, director of BioNet, assistant professor of laboratory medicine and pathology and co-inventor of IHC Map. “For many of those functions, companies require both academic surgical pathologist skills and access to biospecimens or techniques that they may not have internally.”
BioNet's tissue procurement and histology services are available to researchers in both the public and private sector. The lab procures biospecimens, such as tissue and blood samples, from subjects who have given consent, stores the specimens and associated annotation data, and reports the data, from which patient-identifying information has been removed, to the researcher.
The instrumental tool in this partnership between industry and academia is IHC Map, software that analyzes tissue samples and identifies protein markers for disease. Without the software, a pathologist must analyze multiple slides individually, and make a qualitative judgment on the results.
IHC Map allows protein or gene signatures taken on multiple sections to be aligned and visualized in a heatmap-like fashion. The technology improves the multiplexing of biomarkers on a tissue section, and allows the computation of expression to be reported as a comparison to other more stable proteins in the sample.
The patent-pending software was developed at University of Minnesota and will be refined in Flagship’s pharma services by both veterinary and medical anatomic pathologists. Flagship Biosciences helps pharmaceutical and medical device clients develop tissue-based diagnostics.
“Seventy to ninety million glass slides are analyzed each year in pharmaceutical drug development, and maybe another ten million in medical device development,” said Steven Potts, CEO of Flagship. “We think this collaboration will make it easier for these clients to have specialized medical pathology expertise combined with quantitative techniques from Flagship.”
“Most diseases are due to alterations of genes that manifest themselves at the level of protein expression,” said Schmechel. “To characterize disease it is very useful to look at protein expression. Often looking at the expression of one protein is not sufficient, or not powerful enough to optimally characterize the disease. It’s better to look at multiple proteins simultaneously.”
Identifying protein expression across multiple genes can answer key questions for researchers: What is the nature of the disease? How is it likely to behave in the patient? Will the disease be responsive to a given therapy? “It’s been found that combining information from multiple genes to characterize tissue is a powerful way to identify aggressive cancers,” said Dr. Greg Metzger, co-inventor of IHC Map and associate professor of radiology at the U of M. In addition to quantifying expression of these proteins in a quantifiable measurement, the software also allows for greater standardization across tissue samples, and requires less time for the pathologist to analyze slides.
IHC Map was invented by Schmechel and Metzger; Stephen Dankbar, a software programmer from the department of radiology; and Jonathan Henriksen, aniv> information technology specialist from BioNet. The research was funded by the National Institutes of Health and the American Recovery and Reinvestment Act.
The mission of the University of Minnesota’s Office for Technology Commercialization is to translate University research into new products and services that provide growth opportunities for its licensees, benefit the public good, improve the quality of life, and generate revenue to support the University’s research and education goals.