Rules-Based Medicine, Inc. announces commercial release of VeriPsych™, diagnostic aid for recent onset schizophrenia

An October 6th media release form Rules-Based Medicine, Inc.:

Announcement coincides with Mental Illness Awareness Week, October 3 – 9, 2010

AUSTIN, Texas — October 6, 2010 /PRNewswire/ — Rules-Based Medicine, Inc. (RBM), today announced the widespread commercial availability of VeriPsych™, the first and only blood-based diagnostic test to aid in confirming the diagnosis of recent onset schizophrenia, a potentially devastating and costly mental illness that affects about 24 million people worldwide. VeriPsych is an innovative molecular diagnostic tool designed to complement the healthcare provider’s clinical impression.

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 Prof. Sabine Bahn, (Sa-bee-neh Baa – hn) Director of the Cambridge Center for Neuropsychiatric Research in the United Kingdom 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. We are pleased to make this announcement during Mental Illness Awareness Week. 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.”

About VeriPsych

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 signaling.

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.

More information about the test can be found at www.veripsych.com.

About Rules-Based Medicine, Inc.

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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VeriPsych is a trademark of Rules-Based Medicine, Inc.

Company Contact:

Christopher Martin
Managing Director, Communications
512-275-2623
512-627-9058 (mobile)
chris.martin@veripsych.com

New blood-test to aid in schizophrenia diagnosis

A July 1st news release from the University of Cambridge:

A new blood-test resulting from research at Cambridge University could aid in the early diagnosis of recent-onset schizophrenia – complementing the traditional patient interview-based diagnosis.

VeriPsych, developed by Professor Sabine Bahn, Director of the Cambridge Centre for Neuropsychiatric Research, and collaborators at Psynova Neurotech and Rules-Based Medicine, is based upon a blood-based biomarker test - where characteristics are objectively measured and evaluated as an indicator of the presence of disease.

Professor Sabine Bahn, said: "Schizophrenia is a complicated and challenging disease, yet current diagnostic approaches continue to be based on patient interviews and a subjective assessment of clinical symptoms. We expect VeriPsych to be used as an aid to this current process, and we hope it will provide the psychiatrist with additional confidence in their evaluation, as well as speed up the process."

Schizophrenia is a disease that typically begins in early adulthood; between the ages of 15 and 25, affecting 51 million people worldwide with more than 250,000 cases in Britain. Current diagnosis of Schizophrenia is conducted through interviews by a psychiatrist, who follows structured guidelines such as The Diagnostic and Statistical Manual of Mental Disorders, a process that can take several months.

During VeriPsych's developmental stage, researchers analysed 200 biomarker candidates individually and in combination to assess their connection to schizophrenia. They discovered a set of 51 biomarkers with linkages to schizophrenia and to various biochemical pathways, including inflammation, metabolism and cell-to-cell signaling. In a subsequent study, the 51 biomarkers were validated in combination with a mathematical process to separate schizophrenia patients from normal controls. The study included analysis of more than 800 well-characterised blood samples collected by leading psychiatric hospitals.

The research was published in the online journal Biomarker Insights. Commercial rights resulting from this research are held by Psynova Neurotech Ltd., which was launched by Cambridge Enterprise in 2005 and is now majority-owned by Rules-Based Medicine, Inc. Professor Bahn is the Co-Founder, Director, and Chief Scientific Officer of Psynova.

Also see:

Validation of a Blood-Based Laboratory Test to Aid in the Confirmation of a Diagnosis of Schizophrenia (PDF)


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