The first and only blood-based diagnostic test to aid in confirming the diagnosis of recent onset schizophrenia, resulting from research at the University of Cambridge, has been made commercially available by Rules-Based Medicine, Inc (RBM), a biomarker testing laboratory based in Austin, Texas.
Commercial release of VeriPsychTM, diagnostic aid for recent onset schizophrenia
VeriPsychTM is an innovative molecular diagnostic tool designed to complement the healthcare provider’s clinical impression. Schizophrenia is a potentially devastating and costly mental illness that affects about 24 million people worldwide.
VeriPsych, based on the simultaneous measurement of 51 different protein and hormone biomarkers with an associated mathematical decision rule, compares the biomarker profile of a patient with suspected schizophrenia to that of patients with a confirmed diagnosis of schizophrenia. VeriPsych was developed by RBM to aid in the confirmation of the diagnosis of recent-onset schizophrenia, as reported in a study published in the May 2010 edition of Biomarker Insights.
“Schizophrenia is commonly associated with an inevitable disabling decline in mental and overall health, but we are understanding more and more that early therapeutic intervention can alter that prognosis,” said Professor Sabine Bahn, Director of the Cambridge Centre for Neuropsychiatric Research and an RBM collaborator.
“Ultimately, clearer and earlier diagnosis may lead to reduced disability, more effective treatment, improved patient outcomes and enhanced quality of life for patients.”
Each year 1.3 million patients in the United States and 2 million patients in Europe present with early signs that could be schizophrenia. Signs of schizophrenia, which include hallucinations, confusion, delusions and cognitive deficits, are often indistinguishable from those of other mental health or central nervous system disorders, presenting frequent diagnostic challenges.
Diagnosis of schizophrenia is typically accomplished through the clinician’s evaluation of symptoms. If left untreated or improperly treated, schizophrenia can lead to worsening patient conditions and ultimately poor outcomes. Neuropsychiatric conditions, including schizophrenia, are a leading cause of disability, accounting for approximately one third of years lost to disability among people aged 15 years and over.
“VeriPsych was developed through targeted research combining RBM’s proprietary multiplexing technology and unique biomarker discovery capabilities, specifically in the area of mental illness,” said RBM Chief Executive Officer Craig Benson. “We believe this test will be useful to mental healthcare providers seeking to confirm diagnostic decisions that can help patients and families living with mental illness. VeriPsych is an important step in RBM’s ongoing efforts to develop and provide quantitative diagnostic tools for healthcare providers treating patients with neuropsychiatric disorders.”
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VeriPsych is an objective blood-based molecular diagnostic tool that utilizes a proprietary set of 51 biomarker immunoassays. These biomarkers are associated with specific biochemical pathways, including inflammation, metabolism, and cell-to-cell signalling. VeriPsych is a Laboratory Developed Test (LDT) that uses a decision rule to evaluate the similarity of a patient's biomarker pattern to that of patients with a medically confirmed diagnosis of schizophrenia. Its intended use is as an aid in the confirmation of the diagnosis of schizophrenia in patients with recent onset of symptoms and without co-morbidities such as diabetes, severe inflammation or autoimmune disease. It is not intended to provide a definitive diagnosis of schizophrenia. VeriPsych was developed and its performance characteristics were determined by RBM. The test is performed by RBM in compliance with CLIA (Clinical Laboratory Improvement Amendments) regulations. www.veripsych.com
Rules-Based Medicine's biomarker testing service provides clinical researchers, physicians and healthcare providers with reproducible, quantitative, multiplexed data for hundreds of proteins to advance drug development and patient care. The Company's proprietary Multi Analyte Profiling (MAP) technology offers pre-clinical and clinical researchers broad, cost-effective protein analyses in multiple species from a small sample volume. MAP technology also supports RBM's program for development of molecular diagnostics that aid in the detection of complex diseases and conditions in areas of unmet medical need such as neuropsychiatry, nephrology, immunology and cardiology. RBM's first molecular diagnostic test, VeriPsych™, is a blood-based test that aids in the confirmation of diagnosis of recent-onset schizophrenia by evaluating a proprietary set of 51 protein biomarkers. RBM also offers innovative and proprietary ex vivo testing systems such as TruCulture™, the first fully-closed, reproducible whole blood culture system. More information about RBM may be found at www.rulesbasedmedicine.com
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