ORION/UNIVERSITY OF GLASGOW TO IDENTIFY EPIGENETIC BIOMARKERS.

Orion Genomics, St. Louis, has initiated a collaboration with leading researchers at University of Glasgow to discover novel epigenetic biomarkers for the development of tests that screen for cancer at an early stage and provide personalized information about how tumors are most effectively treated. Under the collaboration, scientists at Orion and the University of Glasgow will use Orion's methylation technologies to identify biomarkers useful in the detection and treatment of cancers of the lung, breast and ovaries.

Methylation refers to naturally occurring chemical modifications of DNA that regulate gene function. Abnormal DNA methylation is often found on DNA from cancerous cells and is believed to impact a tumor's sensitivity to chemotherapeutic drugs.

The research will use Orion's proprietary DNA methylation technologies, including MethylScope(r) microarrays and MethylScreen(r) PCR assays. The groups will compare patterns of DNA methylation from normal and tumor DNA to identify specific patterns of abnormal methylation that indicate the presence of cancer and provide information about its stage and type. Orion will develop novel diagnostics based on these patterns that detect trace amounts of methylated tumor DNA in easily accessed patient samples including blood serum, biopsies, and cell scrapes.

"DNA methylation-based diagnostics have the potential to substantially change the way physicians first diagnose and later treat cancer patients," said Professor Robert Brown, Ph.D., University of Glasgow. "We are excited to collaborate with Orion Genomics, whose microarray and PCR technologies are at the world forefront for methylation analysis, both for marker discovery and for applying methylation diagnostics in a clinical setting. These types of technologies may prove to be extremely powerful if DNA methylation diagnostics are to be used to improve patient outcome and as part of novel strategies in clinical trials."

"Professor Bob Brown is a leader in translation research who has dedicated much of his career to understanding the role of methylation in cancer," said Nathan Lakey, CEO and president of Orion Genomics. "Professor Brown - working together with clinical trial groups, ethics committees and with support from Cancer Research UK - has carefully assembled tumor banks that will enable scientists in his lab, in collaboration with Orion, to find biomarkers for novel therapy selection and screening diagnostics and will expand Orion's exciting pipeline of diagnostic products. We are excited to add the University of Glasgow to our list of collaborations with high-caliber research institutions."

About DNA Methylation

Each cell in the body must store, express and copy DNA that is approximately two meters long, which is 200,000 times the width of the cell. An elaborate mechanism for packaging the DNA is required by the body to store it. DNA methylation is a chemical sequence found on the outside of DNA sequence, which enables storage of DNA. Genes that are not being used are methylated to be packaged very tightly so that they are unexpressed or effectively silent. By contrast, genes that are needed are not methylated. Their loose packaging allows them to be expressed and regulate the function of the cell. DNA methylation is stable, detectable, quantifiable, and heritable. Because errors in DNA methylation accumulate with age at a far greater rate than errors in the DNA sequence, it is a major factor in the presence of disease such as cancer, and is a rich source of biomarkers for novel diagnostic tests.

About Second Code(tm) Technologies

Orion's proprietary biomarker discovery platform, MethylScope(r) technology, was recently published in Nature, and is the subject of numerous patent applications. A single MethylScope(r) microarray is capable of quantitatively detecting the methylation status of each and every human gene. By comparing methylation profiles of two or more samples, Orion and its partners discover biomarkers associated with specific diseases. MethylScope(r) technology is the only platform capable of detecting inappropriate DNA methylation for all human genes on a single array, providing a fast, cost-effective, and comprehensive biomarker discovery tool.

Orion's MethylScreen(r) technology leverages biomarkers discovered using its MethylScope technology to develop of a new class of oncology diagnostic kits. MethylScreen is a reliable enzyme-based real-time PCR technology that is compatible with testing platforms widely used in clinical laboratories. The sensitivity of MethylScreen assays enables Orion's scientists to measure unique qualities of epigenetic DNA that are indicative of disease progression. MethylScreen assays provide critical clinical information about disease progression using blood serum and other easily collected patient samples. MethylScreen is unique in that it is the only platform that does not rely on bisulfite conversion, a harsh chemical process that has been shown to destroy more than 94% of the tumor DNA in patient samples.

About Orion Genomics

Orion Genomics, the Second Code biotechnology company, develops molecular diagnostic products to detect cancer at its earliest stages and to aid in appropriate therapy selection. Orion's unique methylation detection technologies, MethylScope and MethylScreen, are the most effective technologies for the identification and interpretation of abnormal epigenetic patterns of genes. Orion Genomics is located in the Center for Emerging Technologies in St. Louis.

For more information, visit http://www.oriongenomics.com.