Woburn, MA (October 25, 2004) – U.S. Genomics today announced the availability of its Direct™ miRNA reagents and kits to detect known human and mouse micro RNA’s (miRNA) using the company’s Trilogy™ Single Molecule Analyzer platform. The Trilogy™ platform directly detects and quantitates individual molecules of miRNAs, as well as DNA, RNA, and proteins, without the need for amplification. The newly available Direct™ miRNA kits enable researchers to screen their samples quickly and efficiently against a panel of known miRNAs, and to validate and characterize specific miRNAs of interest. The Direct™ miRNA reagents extend the research capabilities of the Company’s Trilogy™ platform, for which U.S. Genomics currently has more than 30 scientific collaborations in place with diagnostic, pharmaceutical, and biotech companies and leading academic institutions.

“MicroRNAs are key factors in the regulation of development, disease, and target drug pathways,” said Stephen P. DeFalco, Chairman and CEO of U.S. Genomics. “The Direct™ miRNA reagents for the Trilogy™ platform are the first technology to provide researchers with rapid, direct quantitation and exquisite sensitivity for these difficult-to-study molecules.”
Release of the Direct™ miRNA reagents for the TrilogyTM platform is a significant milestone for U.S. Genomics in pioneering Single Molecule Biology instruments and assays. In contrast to most traditional detection techniques, where reliance on amplification of target molecules increases assay cost and complexity and can undermine the researcher’s ability to quantitate accurately, the Direct™ miRNA reagents and the Trilogy™ platform detect individual molecules directly. U.S. Genomics’ direct detection technology integrates high-acuity optics, fluorescence detection, and microfluidics, and is especially valuable to researchers for molecules that are difficult or impossible to amplify, such as microRNAs, siRNAs, and proteins.

Importance of Small RNA
Understanding the function of RNA molecules is key to unlocking the pathways of disease and biology. Several tools offer well-established methods for studying some classes of RNA. However, traditional analytic tools have not proven particularly effective with small RNA, a subgroup of RNA that has recently become of great interest to researchers. Small RNAs, such as microRNAs, play an important role in cell development and disease by controlling the levels and activities of other RNAs and proteins in the cell. These molecules are of increasing interest in a wide array of fields, from cancer to human development, and an understanding of small RNA offers a promising new avenue for therapeutic intervention. Researchers have, until now, been unable to study this RNA subgroup in depth because of a lack of suitable tools.

U.S. Genomics’ Trilogy™ Platform
U.S. Genomics is the pioneer of Single Molecule Biology instruments and assays. Single molecule biology is critical to breakthrough therapies and more accurate diagnostics for the healthcare industry, where such advances depend on understanding how cellular material functions and interacts at the molecular level. Understanding how biological pathways manifest themselves differently in normal and diseased states hinges on a researcher’s ability to detect and accurately quantitate these small molecular variances.
Most traditional detection techniques rely on amplification of a target molecule, an approach that increases assay cost and complexity and can undermine the researcher’s ability to quantitate accurately. The TrilogyTM technology’s Direct™ detection approach is especially valuable to researchers for molecules that are difficult or impossible to amplify, such as microRNAs, siRNAs, and proteins. The TrilogyTM platform combines advances in microfluidics, optical engineering, and novel labeling strategies for life science applications in research, drug discovery and development, and diagnostics.

ABOUT U.S. GENOMICS
U.S. Genomics is a leading marketer and developer of technologies that allow genetics, functional genomics, and diagnostics to be performed at the single molecule level. The company’s technology platform can directly analyze individual molecules of DNA, RNA, and proteins without the need for amplification and combines advances in microfluidics, optical engineering, and novel labeling strategies. The technology has life sciences applications in the areas of research, biodefense, drug discovery and development, and diagnostics. For more information, please visit www.usgenomics.com.