Originally published May 27.
By Turna Ray
Rules-Based Medicine has identified a biomarker pattern that may be useful to Roche in developing a personalized drug for a central nervous system disorder.
RBM said this week that it has netted a "significant" milestone in its ongoing collaboration with Roche to advance a companion diagnostic for an unnamed CNS treatment in Roche's pipeline.
An RBM spokesperson told PGx Reporter that the company used its DiscoveryMAP quantitative immunoassay platform to identify a promising multi-protein biomarker pattern using blood samples provided by Roche from a late-stage drug trial. The company also used a biomarker database provided by its subsidiary Psynova Neurotech for the project.
RBM claims that its Multi-Analyte Profiling, or MAP, platform tests for 188 different markers, including cytokines, chemokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, cancer markers, kidney toxicity markers, CNS biomarkers, as well as other key serum proteins.
The company markets a molecular diagnostic test called VeriPsych that operates on the DiscoveryMAP platform, and is offered through RBM's CLIA lab. The blood-based test helps doctors confirm whether patients have recent-onset schizophrenia based on a panel of 51 biomarkers.
Although the RBM spokesperson couldn't name the Roche drug involved due to confidentiality agreements, the companies announced in 2009 that they were collaborating on the discovery and development of a companion test for a schizophrenia drug owned by Roche (PGx Reporter 12/09/2009).
Roche's pipeline lists a glycine transporter-1 inhibitor (RG 1678) in Phase III development for schizophrenia.
Phase II study results released late last year showed that RG 1678 reduced negative symptoms of schizophrenia and improved study participants' personal and social functioning. Both outcomes met statistical significance. This randomized, double-blind, parallel group trial involved 323 schizophrenia patients who received either RG1678 or placebo. However, the publicly reported Phase II data doesn't discuss the use of biomarkers to personalize treatment.
Clinicaltrials.gov also lists a study being sponsored by Roche in which researchers are measuring how the antipsychotic therapy RO4917383 impacts biomarker measures of cognitive dysfunction, as well as the efficacy and safety of the drug in patients with schizophrenia.
If the protein signature identified by RBM is validated and translated into a companion test for a Roche drug, then commercialization and regulatory activity will be handled by Roche, according to the RBM spokesperson.
Although the financial arrangements between Roche and RBM are not known, RBM's milestone could ultimately end up as a monetary gain for Myriad Genetics. On April 27, Myriad announced plans to acquire RBM, and the deal closed this week. Under the terms of its acquisition deal with Myriad, RBM's headquarters will remain in Austin, Tex., but the company's name will be changed to Myriad RBM (PGx Reporter 05/04/2011).
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