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Rules-Based Medicine and Psynova Neurotech to Co-Develop Blood Test for Diagnosis of Schizophrenia.

Partnership gives RBM exclusive rights to market and sell diagnostic test worldwide

AUSTIN, Texas -- Rules-Based Medicine, Inc. (RBM), the leading multiplexed biomarker testing laboratory, announced today that it is partnering with Psynova Neurotech to co-develop and commercialize a blood test for the diagnosis of schizophrenia. RBM and Psynova will focus on the unmet clinical need for an objective and reliable diagnostic test to accelerate and optimize the treatment of schizophrenia. Under the terms of the agreement, the companies will collaborate on the validation, regulatory approval and manufacture of a diagnostic blood test for schizophrenia that will be sold worldwide exclusively by RBM.

The co-development agreement will leverage Psynova's discovery of proprietary biomarkers with RBM's protein biomarker platform and CLIA-certified central lab service to accelerate the delivery of an objective diagnostic blood test for schizophrenia. These biomarkers were discovered through Psynova's collaborative research program with co-founder Dr. Sabine Bahn of the Cambridge Centre for Neuropsychiatric Research (CCNR) at the Institute of Biotechnology, Cambridge University. The Psynova/CCNR research program included the processing of clinical samples on RBM's HumanMAP([R]), which features over 150 quantitative immunoassays.

"This is a very exciting and important partnership for Psynova," said Dr. Sabine Bahn, director and co-founder of Psynova Neurotech. "RBM's technology platform and clinical screening expertise give us a rapid path to bring the candidate biomarkers identified through our research efforts to the benefit of patients. The tests will be a tool to help general practitioners and psychiatrists in the difficult task of diagnosing and treating patients much sooner, ideally, when symptoms are still mild. The Psynova biomarkers not only have the potential to help in the identification of disease subtypes, but also in deciding the best treatment options, monitoring patient responses and facilitating novel approaches to drug discovery."

The current diagnosis of schizophrenia is highly subjective and time-consuming, due to the lack of objective biological tests specific for the disease. The resulting uncertainty in diagnosis leads to delayed treatment, and, in turn, extended suffering and hardship for patients and their families. In the few studies where early treatment has been implemented in high-risk patient groups, poor outcomes were substantially reduced, as were the duration of untreated illness, inpatient days and the time to remission. Therefore, a test that provides earlier and more accurate diagnosis of the disease would deliver not only improved patient outcomes but also greatly reduce the overall costs of schizophrenia to health services and society1.

"Complex diseases like schizophrenia are an ideal fit for RBM's multiplex testing approach," said RBM CEO T. Craig Benson. "By combining RBM's expertise in assay development and testing services with Psynova Neurotech's proprietary biomarkers, we can improve the standard of care for schizophrenia, ultimately providing significant savings to health care systems worldwide. We anticipate that this is the first of many collaborations between the two companies, further leveraging other discoveries made by Psynova and the Cambridge Centre for Neuropsychiatric Research."

The Global Alliance of Mental Illness Advocacy Networks - Europe (GAMIAN - Europe), a pan-European patient-driven federation of national organizations assisting people affected by mental illness, also welcomed the announcement.

"Any diagnostic tool that aids in the early identification of schizophrenia and other chronic mental illnesses will help people begin treatment earlier to avoid much of the pain, hardship and deterioration caused by these devastating diseases," said Dolores Gauci, president of GAMIAN - Europe. "Further, such a test could help affected individuals and their carers maintain a better quality of life."

More about Schizophrenia

Schizophrenia is a complex, progressive, seriously debilitating psychiatric disorder that affects 1.1 percent of the population -- or ~2.4 million American adults -- but accounts for a quarter of all mental health costs and takes up to one third of psychiatric hospital bed occupancy2. Direct costs such as general practitioner and specialist consultation, community psychiatric nursing visits, hospital admissions and drug treatment, and indirect costs, which are dominated by lost productivity through incapacity, unemployment and premature mortality, are estimated to total $40 to $60 billion each year in the United States3.

About Psynova Neurotech Ltd.

Psynova Neurotech was established in 2005 by Dr. Sabine Bahn, M.D., Ph.D., MRCPsych, and Prof Chris Lowe, Ph.D. of the University of Cambridge and funded since inception by Porton Capital, for the commercial development and exploitation of novel biomarkers for neuropsychiatric illnesses. Building on 12 years of groundbreaking research by Dr. Bahn, Psynova Neurotech supports research and has options to take exclusive licenses to developments from Bahn's laboratory within the newly established Centre for Neuropsychiatric Research (CCNR) at the University of Cambridge. Although initial efforts have focused on schizophrenia, Psynova Neurotech intends to expand into other related therapeutic areas, such as bipolar affective disorder (also referred to as manic depression) and major depression, where it has extensive relevant expertise. At present, there are no validated biomarkers and diagnostic tests for any of these disorders. More information about Psynova Neurotech can be found at www.psynova.com.

About Rules-Based Medicine

Rules-Based Medicine (RBM) provides comprehensive protein biomarker products and services centered on its Multi-Analyte Profiling (MAP) technology. Its service platform (RodentMAP([R]) and HumanMAP([R])) provides pre-clinical and clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of proteins cost-effectively in multiple species, and from a small sample volume. The Company also offers innovative and proprietary ex vivo testing systems such as TruCulture([TM]), the first fully-closed, reproducible whole blood culture system. RBM is actively developing multiplex diagnostic tests to detect the presence of complex diseases and conditions in areas of unmet medical need such as neuropsychiatry, nephrology, immunology and cardiology. More information about RBM is located at www.rbmmaps.com.

1Norman, R.M.G., Malla, A.K., (2001). Duration of untreated psychosis: a critical examination of the concept and its importance. Psychol. Med.31, 381-400; McGorry, P.D., (2002). The recognition and optimal management of early psychosis: An evidence-based reforum. World Psychiatry 1 (2), 76-83; Harrigan, S.M., McGorry, P.D., Krstev, H., (2003). Does treatment delay in first-episode psychosis really matter? Psychol. Med. 33 (1), 97-110; Riecher-Rossler, A., Aston, J., Borgwardt, S., Gschwandtner, U., Pfluger M., (2006). Early detection and treatment of schizophrenia--how early? Acta Psychiatr. Scand Suppl. 429, 73-80.

2Wyatt RJ, Henter I, Leary MC, Taylor E. (1995) An economic evaluation of schizophrenia--1991. Soc Psychiatry Psychiatric Epidemiol. 30, 196-205.

3Wu EQ, Birnbaum HG, Shi L, Ball DE, Kessler RC, et al. (2005) The economic burden of schizophrenia in the United States in 2002. J Clin Psychiatry 66, 1122-1129 and Andlin-Sobocki P, Rosslea W (2005) Cost of psychotic disorders in Europe. Eur J Neurol 12 Suppl 1: 74-77.
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