A New Blood-Based Diagnostic Aid for Schizophrenia

An letter to the editor published in the September 2011 edition of Psychiatric Services:

To the Editor: Many people with schizophrenia exhibit poor insight into and lack of acceptance of their illness (1,2). The absence of objective proof of this disease contributes to this problem. Investigators have been interested in developing a blood-based biomarker test to help identify a biological signature to aid in diagnosis of schizophrenia, particularly in the prodrome of the illness (3,4).

Such a test has recently been developed, validated, and marketed in the United States. This test, VeriPsych, uses a multiplex immunoassay technology that profiles a proprietary disease signature comprising 51 analytes. The test has been found to be 83% sensitive and specific in distinguishing persons with schizophrenia from those without the disorder; the study in which the test's validity was established included more than 500 patients in the development phase and more than 800 patients in the validation phase (5). However, little has been subsequently published about this test, and its clinical utility remains unclear.

Our treatment team administered the test to a 30-year-old woman with a five-year history of schizophrenia who did not accept the fact that she had schizophrenia and who had problems remaining adherent to antipsychotic medications. The test yielded a positive result for the diagnosis of schizophrenia (score of –9199), with a conditional probability score that indicated a 95% chance of having the illness. After being informed of these results, our patient began to accept that her symptoms could be attributed to schizophrenia. For the first time, she expressed interest in learning about schizophrenia, acknowledged a personal connection to her family history of the disorder, and accepted her need of antipsychotic medications. Her therapeutic alliance with her psychiatrist and treatment team has improved, she has enrolled in a college-level class, and her attitude toward antipsychotic treatment remains positive. Her psychiatrist notes that this remarkable change was the result of her confidence in the blood test results—for the first time she had objective data about her illness.

Improving insight and illness acceptance among patients with schizophrenia has proven to be no small task. Psychoeducation, meta-cognitive training, cognitive therapy, and family intervention aimed at developing an understanding and acceptance of schizophrenia have shown only some success (1). Our interest in the test was not to confirm a clinical diagnosis of schizophrenia but to help a patient with schizophrenia accept her illness. We feel that if this test or future serum tests are more widely utilized, then their use as an aid in helping people who have no illness insight or who lack acceptance of their illness may be an important application. We hope that our letter will bring attention to this new test and encourage further research to replicate and validate our results. We also need to develop a better understanding of the clinical and research uses of this blood-based diagnostic aid and of its potential role and place in the treatment of patients with schizophrenia.

Deanna L. Kelly, Pharm.D., B.C.P.P., Sheryl Thedford, Pharm.D. and Gopal Vyas, D.O.

Dr. Kelly is affiliated with the Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore.

When the test was administered, Dr. Thedford was with the Department of Pharmacy Practice, School of Pharmacy, University of Maryland. She is now with the Bernard J. Dunn School of Pharmacy, Shenandoah University, and the Pharmacy Department, Winchester Medical Center, Winchester, Virginia.

Dr. Vyas is with Spring Grove Hospital Center, Baltimore.

Acknowledgments and disclosures

Rules Based Medicine supplied the VeriPsych test but had no involvement in the use of the test, the results, or publication.

The authors report no competing interests.

References

1. Lysaker PH, Buck KD, Salvatore G, et al: Lack of awareness of illness in schizophrenia: conceptualizations, correlates and treatment approaches. Expert Review of Neurotherapeutics 9:1035–1043, 2009 [CrossRef][Medline]
2. Buckley PF, Wirshing DA, Bhushan P, et al: Lack of insight in schizophrenia: impact on treatment adherence. CNS Drugs 21:129–141, 2007 [Medline]
3. Schwarz E, Guest PC, Rahmoune H, et al: Identification of a biological signature for schizophrenia in serum. Molecular Psychiatry epub ahead of print PMID , 2011 [Medline]
4. Dudley E, Hassler F, Thome J: Profiling for novel protemonics biomarkers in neurodevelopmental disorders. Expert Review of Proteomics 8:127–136, 2011 [CrossRef][Medline]
5. Schwarz E, Izmailov R, Spain M, et al: Validation of a blood-based laboratory test to aid in the confirmation of a diagnosis of schizophrenia. Biomarker Insights 5:39–47, 2010 [Medline]

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