AmberGen and Massachusetts General Hospital License Two Novel Autoantigen Biomarkers for Autoimmune Liver Disease to INOVA Diagnostics, Inc.

Published: Mar 14, 2012

WATERTOWN, MA--(Marketwire - March 13, 2012) -

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Two novel autoantigen biomarkers for the autoimmune liver disease Primary Biliary Cirrhosis (PBC), discovered by AmberGen, Inc., in collaboration with the Massachusetts General Hospital (MGH), were exclusively licensed to INOVA Diagnostics, Inc., part of the Werfen Group, and a world-leader in clinical assays for autoimmune disease. Discovery of these biomarkers was made possible by the use of AmberGen's proprietary proteomic biomarker discovery pipeline and funded by an Advanced Technology Small Business Innovation Research (SBIR) grant to AmberGen from the National Institute of Allergy and Infectious Disease, part of the National Institutes of Health. Following the work done by AmberGen and MGH, the biomarkers where subjected to further clinical validation by INOVA.

PBC is an autoimmune disease in which the liver's bile ducts are destroyed. According to Dr. Donald Bloch, M.D., of MGH, "Liver damage caused by PBC is a leading indication for liver transplantation. The disease is often difficult to diagnose, especially at early stages. However, if the disease is identified at an early stage, the patient can be treated with ursodeoxycholic acid, a safe and inexpensive medication. Treatment may prevent or at least delay the development of liver failure. Additional diagnostic tests, using new autoantigen biomarkers, will assist clinicians in their diagnosis of this illness and permit early treatment." The licensing agreement will allow INOVA to add the novel biomarkers to their current repertoire of FDA-cleared PBC tests, for improved diagnosis of this debilitating disease. Dr. Gary Norman, Ph.D., Director of R&D at INOVA, stated, "The addition of these new autoantigens to our PBC offerings may increase the overall accuracy of diagnosis, and may ultimately add to the understanding of the etiology of this disease."

According to Dr. Mark Lim, Director of Proteomics at AmberGen, "All three parties bring an important skill to the table which is helping to translate these biomarkers from the bench to the clinic; demonstrating the power of a multidisciplinary approach, we have combined our core expertise in innovative proteomics technologies and discovery of protein-based biomarkers, the clinical expertise provided by MGH, and INOVA's superior strength in developing and commercializing FDA-cleared diagnostic tests."

About AmberGen, Inc.
AmberGen is a privately held biomarker discovery and clinical diagnostic company based in Watertown, Massachusetts. AmberGen's proprietary molecular profiling technology enables physicians to more accurately make optimal therapeutic decisions tailored to individual patients. This is made possible by identifying unique molecular fingerprints in tumors, blood, and other biospecimens that are characteristic of specific diseases and their outcomes. AmberGen's approach combines unique patented technology in the area of proteomics, genomics, and bioinformatics. Further information about AmberGen can be found at www.ambergen.com.

About INOVA Diagnostics, Inc.
INOVA Diagnostics, Inc., is a privately held company headquartered in San Diego, California, which was acquired by Werfen Group in 2008. Werfen Group's in vitro diagnostics (IVD) division also includes Instrumentation Laboratory and Biokit. INOVA develops and manufactures in vitro medical diagnostic tests for autoimmune disease that are used in medical labs, hospitals and universities around the world, and is considered a leader in the development and commercialization of new technologies and new diagnostic markers in the field of autoimmunity. The company employs approximately 300 individuals globally. Further information about INOVA can be found at www.inovadx.com.