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Minding their assays
January 2010
by Jeffrey Bouley  |  Email the author


AUSTIN, Texas—With a combination of a schizophrenia biomarker portfolio and a biomarker identification platform, Rules-Based Medicine Inc. (RBM) in early December announced an exclusive research and licensing agreement with Roche through RBM's majority-owned subsidiary, Psynova Neurotech Ltd. of Cambridge, United Kingdom.  
Using Psynova's schizophrenia biomarker portfolio and RBM's DiscoveryMAP technology, the deal calls for collaboration on the discovery, development, validation and commercialization of diagnostic immunoassays to aid the clinical development and commercial differentiation of novel treatments for schizophrenia.  
"We've been selling biomarker testing services to pharma companies since 2002, but it's only in the past several years that we've had biomarker patterns that are specific to particular disease areas, and these have been important in our ability to start conversations with various pharma companies to use these panels for their biomarker research," notes Dr. Sam LaBrie, vice president of corporate development at RBM. "We're very interested in neuroscience in particular and we don't just want to be the company that you go to just to run a few samples."
Instead, RBM wants to be a strong part of the discovery and development process and the launching of companion diagnostics, he says.  
"We have all these immunoassays that are authenticated and sensitive and on the same platform where we could develop a companion diagnostic, so it's a very efficient development pathway," LaBrie says. "We basically offer discovery, validation and commercialization all on same platform, and we see ourselves as a great partner on companion diagnostics."  
Under the terms of the agreement, Roche will contract Psynova to identify candidate serum protein biomarkers that seem useful in the prognosis of disease progression and in predicting or monitoring the efficacy and safety of an undisclosed compound from Roche's central nervous system pipeline.  
Psynova will use its proprietary schizophrenia biomarker panels, its extensive central nervous system disease database and its access to RBM's DiscoveryMAP technology to identify a specific biomarker signature that could serve as a companion diagnostic. Any resulting companion diagnostic will be developed either by Psynova and RBM—which serve as the preferred developer for the companion diagnostic in partnership with Roche—or independently by Roche, which would result in milestone and royalty payments to Psynova.  
"We are excited to enter into this partnership with Roche," said Dr. Sabine Bahn, chief scientific officer and founder of Psynova. "This alliance is part of an ongoing strategy to leverage the value of our biomarker portfolio in both the development of novel diagnostic aids for physicians and the accelerated development and delivery of novel therapeutics for patients."  
According to data cited by Roche and RBM in their announcement of the deal, schizophrenia affects some 4 million people in the European Union and 2.4 million people in the United States.  
Moreover, each year as many as 2 million new patients in the European Union and 1.3 million new patients in the United States present with early signs of psychosis. Although most of these patients do not have schizophrenia, the medical evaluation is time consuming and expensive, due to its subjective nature. Biomarkers have the potential to facilitate identification of patients that will benefit from specific treatments and monitor their responses during treatment, thus making the entire process better for patients and healthcare providers alike.  
Rules-Based Medicine is a CLIA-certified biomarker testing laboratory that solves complex therapeutic development, diagnostic and treatment challenges with innovative products and services. The company's proprietary multi-analyte profiling (MAP) platform, from which the DiscoveryMAP technology derives, is said to make the drug discovery and development process more efficient and effective by providing preclinical and clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of proteins from small sample volumes.  
Building on the MAP platform, RBM has developed a range of solutions that include: a self-contained whole-blood culture system that brings reproducibility and simplicity to ex vivo immune response measurement; novel and companion diagnostic tests for complex diseases and therapies; therapeutic-specific MAPs custom-designed for late-stage clinical development; and new assays for the early detection of renal damage.  
Psynova Neurotech was established in 2005 by Bahn and Dr. Chris Lowe, a professor at the University of Cambridge, to build on 12 years of research by Bahn in identifying novel biomarkers for neuropsychiatric illnesses. Psynova Neurotech, together with the Bahn laboratory and Rules Based Medicine, recently announced the discovery and characterization of a combination of protein biomarkers that demonstrate utility as an adjunctive aid in the differential diagnosis of schizophrenia.
As a result of this clinical milestone, RBM made an additional investment in Psynova, which is how the company became a majority-owned subsidiary of RBM. Psynova and RBM are developing several products in related therapeutic areas and are also actively exploring the potential of these biomarker panels as companion diagnostics and therapy monitoring tools.

Code: E011013



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