Drug, vaccine and biomarker discovery processes are facing major challenges to understand and validate, in clinical material, large numbers of candidate targets that are being generated by genomic and proteomic technologies. By reducing the number of potential targets to proteins whose expression levels are clearly altered in specific disease states, new products can be developed more quickly and cost-effectively. Understanding the expression patterns of these proteins in normal tissue and organs can also flag potential toxicology problems sooner in the drug development process.

Commercial options to address these tissue analysis needs are in three areas; 1) tissue arrays, constructed from small cores of tissue, are currently offered by numerous suppliers. These have inherent limitations in capacity and consistency, do not eliminate microscopy, and have the same sensitivity and quantitation limitations as standard tissue staining; 2) efforts to automate processing and image analysis of standard tissue staining methods do not address sensitivity and quantitation; 3) several “clinical genomics” initiatives have been organized to develop collections of frozen tissue and provide standard tissue analysis services. This market is currently in a very early stage with no dominant suppliers, and with opportunity for dramatic growth. EPI’s unique approach has demonstrated ability to deliver the benefits of quantitation with great sensitivity to screen for expression and localization of proteins in large and readily available collections of FFPE tissue.

Rapid market adoption of arrays of specific protein sets, both commercial products and arrays produced by researchers themselves, is encountering a limitation in the availability of protein arraying technology that yields reproducible results with variable protein solutions. The protein array market has been projected in a recent study (BioInsights) to grow 36% annually to $427 million in 2007. Similarly, although laser microdissection instruments have achieved significant commercial success, full exploitation of this method in gene and protein expression analysis requires improved speed and automation and the ability to microdissect FFPE tissue. EPI has demonstrated that its unique non-contact, laser-based arraying and microdissection technology can play a significant role in production of high-quality protein arrays and in precision tissue microdissection.

With limited funding and less than a year of development, EPI’s scientists have achieved proof-of-concept for the company’s core Liquid Tissue and ExCellerator technologies. During 2004, the company expects to complete collaborations now underway with leading research centers to demonstrate the advantages of its technology in key projects, and to complete development of prototype reversed phase tissue protein arrays to enable the company to engage in contract services and to enter a commercial product development phase later in 2004.

Significant Opportunities: Balanced for Near and Long Term Growth

EPI’s principal focus is to commercialize Liquid Tissue protein arrays designed to enable industrial and academic researchers to profile expression levels of their proteins of interest in large sets of highly defined tissue types. Products will include general profiling arrays such as multi-cancer chips, human-chips, and a brain-chip, as well as specific arrays of many highly targeted tissue regions from all stages and grades of specific cancers and other diseases. EPI plans to generate near-term revenue through service collaborations to analyze patterns of protein expression and to construct customized Liquid Tissue protein arrays for its customers. Additional opportunities to commercialize the ExCellerator technology as a significant improvement in both protein arraying and tissue microdissection are being discussed in partnerships with instrument companies. Major potential also exists in the clinical diagnostic market for EPI’s Liquid Tissue technology to replace less reliable existing methods for detection of protein markers, such as HER2/neu, in patient tissue.