Rules-Based Medicine Inc. (RBM) now offers VeriPsych, according to the company, the first and only blood-based diagnostic test to aid in confirming the diagnosis of recent onset schizophrenia, a costly mental illness that affects approximately 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 those of patients with a confirmed diagnosis of schizophrenia.

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.

Impressions: VeriPsych was developed as a molecular diagnostic tool designed to complement the healthcare provider's clinical impression.

The Diagnostic Process

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 older.

"Unlike many other areas of medicine, psychiatry has never had an objective tool to use in the diagnostic process," said Michael Spain, MD, chief medical officer, Rules-Based Medicine, Austin, TX. "While other specialties, such as orthopedics or cardiology, use imaging technology and other testing to reach a diagnosis, psychiatric illnesses such as schizophrenia have, until now, been diagnosed based on the subjective impression and observation of a physician. VeriPsych offers these specialists an innovative objective tool to help them to reach a diagnosis that can lead to effective treatment in a timely fashion."

"Our test is often incorrectly referred to as a genetic test or having something to do with genetics," Dr. Spain added. "Our tests measure blood-based proteins, not genes."

"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 Craig Benson, CEO, RBM. "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."

Biomarkers Are Key

VeriPsych aids in confirming the diagnosis of recent onset schizophrenia by measuring blood-based protein biomarkers that are associated with mental illness. "These biomarkers are associated with specific biochemical pathways, including inflammation, metabolism and cell-to-cell signaling," explained Dr. Spain. "In measuring these protein biomarkers, we can identify a blood chemistry 'signature' for schizophrenia that can be used in helping to diagnose this illness."

Biomarkers linked to schizophrenia were discovered through measuring hundreds of biomarkers in serum samples collected from 445 individuals including 163 patients with recent onset schizophrenia, 32 bipolar disorder patients, 50 major depressive disorder patients and 200 healthy matched control subjects. The results identified 36 individual biomarkers with serum concentrations that were significantly different between schizophrenia patients and healthy controls.

VeriPsych is a laboratory developed test 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. While it is not intended to provide a definitive diagnosis of schizophrenia, or to be used as the sole means of patient treatment, VeriPsych opens a valuable new window into this complicated psychiatric condition.

"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 Profesor Sabine Bahn, director, Cambridge Center for Neuropsychiatric Research, 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."

Looking Ahead

"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," Benson added. RBM has additional blood-based neuropsychiatric diagnostic products in its pipeline. "We are hoping to bring a differential diagnostic product to market later this year that will help to distinguish among schizophrenia, bipolar disorder and major depressive disorder in patients presenting with either psychosis or major depression," Dr. Spain concluded.

Karen Appold is a medical freelance writer and editor. Visit www.WriteNowServices.com.