BOULDER, Colo., Oct. 10 /PRNewswire/ -- Source MDx today announced the publication of a paper in Molecular Medicine outlining the importance and relevance of establishing a “normal” reference dataset for gene expression assays to distinguish the molecular profile of a disease condition from that of a healthy population. The study outlined in Molecular Medicine demonstrates that (1) the dynamic range of expression of many immune response genes is limited among healthy subjects; (2) expression levels for most genes analyzed are approximately log-normally distributed; and (3) tight regulation and homeostatic control of gene responses are fundamental characteristics of the immune system as reflected in the narrow range of expression levels and return to set points for key molecules in inflammatory/immune pathways among healthy subjects. The results of this study support that normal reference ranges can be established for gene expression assays, providing critical standards for the diagnosis and management of disease.
The use of quantitative gene expression analysis for the diagnosis and monitoring of disease requires the ability to distinguish pathophysiological changes from natural variations. A series of studies were undertaken to examine the expression of immune-related gene transcripts in whole blood of apparently healthy subjects. To characterize these variations in apparently healthy subjects, quantitative real-time polymerase chain reaction (QPCR) was used to measure various immune response genes in whole blood collected from blood bank donors. In the study discussed in Molecular Medicine, a single time-point study of 131 donors, of 48 target genes 43 were consistently expressed, and 34 followed approximately log-normal distribution. Most transcripts showed a limited dynamic range of expression across subjects.
“We are pleased that the study reviewed in this paper confirms the years of development we have been conducting surrounding the use of a ‘normal’ reference range for disease diagnosis, prognosis and tracking response to therapy,” said Dr. Bankaitis-Davis, Senior Vice President. “Source MDx now routinely uses the healthy normal reference range for over 1,500 genes specific to oncology, cardiovascular disease, autoimmune diseases and infectious diseases for both pre-clinical and clinical trials.”
Source MDx was issued US patent no. 6,960,439 on November 1, 2005 covering the work described in the Molecular Medicine article. The patent claims 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. This patent also covers the Source MDx Healthy Normals Reference Dataset, a gene expression dataset of 400 healthy blood bank donors which is the foundation for its commercial biomarker and companion diagnostics services for the pharmaceutical industry.
“The Molecular Medicine article focuses on normal gene expression of the immune system which is a key element of our molecular diagnostic test development for autoimmune diseases including rheumatoid arthritis and multiple sclerosis,” said Karl Wassmann, Chief Executive Officer and President of Source MDx. “Our patented normals technology is also proving to be a valuable toolset for the development of molecular diagnostic tests for early detection of cancer including melanoma, colon, lung, breast and prostate cancer.”
The work described in the Molecular Medicine article was performed under the auspices of the Lawrence Livermore National Laboratory and was supported with funds from the Laboratory Directed Research and Development (LDRD) Program.
Source MDx is focused on the development of RNA-based biomarkers and molecular diagnostics for oncology, cardiovascular, autoimmune and infectious disease. 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. The Company has completed over 150 preclinical and clinical projects for more than 30 leading pharmaceutical, biotechnology and diagnostic companies.
The Molecular Medicine article is now available on line at http://www.molmed.org
For reprints of the Molecular Medicine article please contact Source MDx
Business Development & Services contact: Jim Walther, 303-385-2705, jim.walther@sourcemdx.com
Source MDx
CONTACT: Michelle Linn for Source MDx, +1-508-419-1555,linnmich@sourcemdx.com
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