BOULDER, Colo., Nov. 4 /PRNewswire/ -- Source MDx announced today that it has been issued US patent no. 6,960,439, which describes the discovery of "normal," healthy levels of human gene expression and covers the use of such normal ranges to diagnose disease and response to therapy. Specifically, the patent establishes claims for methods of diagnosing a biological condition using two or more genes linked to inflammation or immune response. A wide range of diseases and disorders are associated with inflammatory and immune events, including autoimmune disorders, cancer, immunosuppression, and cardiovascular, eye, infectious, gastrointestinal, metabolic/endocrine and pulmonary diseases. Source MDx's patent represents the first known intellectual property claim on a normal range of gene expression and lays the foundation for the use of RNA-based molecular diagnostics to monitor an individual's health, disease status and response to therapy.
Source MDx currently uses its patented Healthy Normals Reference Dataset as the foundation for its commercial biomarker services, which are used in drug development.
"The concept of a molecular normal range is a result of Source MDx's substantial investment in the technical process of measuring and interpreting gene expression," said Danute "Bunki" Bankaitis-Davis, Ph.D., Senior Vice President of Source MDx. "The issuance of this patent confirms the importance of this work as it establishes the practice and clinical utility of RNA-based gene expression assays."
Source MDx has been able to define disease-specific gene expression patterns by comparing to the Source MDx normal reference range. "Our pharmaceutical and diagnostic clients are already benefiting from Source MDx's biomarker approach for accelerating drug development and companion diagnostics," said Karl Wassmann, Chief Executive Officer and President of Source MDx. "We believe our enabling technology supports the pharmaceutical industry's goal of achieving the right medicine, for the right person, at the right dosage."
The development of useful biomarkers for molecular diagnostics, which rely on analysis of molecular activity, has been inhibited in the past by an inability to measure gene expression with sufficient precision, as well as a presumption that gene expression is too variable within and between individuals. However, Source MDx's analysis of circulating whole blood collected from healthy donors demonstrates that gene expression is consistent over time in a given individual. In particular, Source MDx's research indicates that inflammatory and immune response genes are tightly regulated, with key markers reflecting immune system health within a narrow range of expression. Source MDx's data further show that such consistency and similarity in gene expression also exists within a healthy donor population.
Source MDx uses its patented molecular diagnostic system to monitor an individual's health, disease status and response to therapy at the molecular level, using RNA from whole blood or tissue samples. Source MDx markets over 20 patented disease and pathway-specific biomarker panels that are used in both preclinical and clinical drug development, and is developing companion patient care diagnostics focused on inflammation and immune response genes. The company has completed over 100 preclinical and clinical projects for more than 30 leading pharmaceutical, biotechnology and diagnostic companies, with over one million gene expression measurements analyzed.
Michelle Linn, 508-419-1555, linnmich@sourcemdx.com.
Source MDxCONTACT: Michelle Linn of Linnden Communications for Source MDx, +1-508-419-1555, linnmich@sourcemdx.com
Web site: http://www.sourcemdx.com/
