Emerging Diagnostic Technologies for Use in Psychiatric Indications

Published by: Decision Resources

Published: May. 29, 2008 - 38 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

The Importance of Diagnostic Technologies for Psychiatric Indications

Value of Biomarker-Based Diagnostics for Psychiatric Diseases

Difficulties in Diagnosing Psychiatric Illness

Presentation of Prodromal Symptoms Can Be Slow and Variable

Several Disorders May Have Similar Symptomatology

Patients with Multiple Mental Illnesses May be Difficult to Diagnose

Some Mental Illnesses May Be Broad Categories of Diseases

Challenges in Determining Optimal Treatment

Current Medical Practice for Psychiatric Indications

Current and Emerging Diagnostic Technologies for Psychiatric Indications

Electroencephalography

Aspect Medical Systems

CNS Response

Memory Pharmaceuticals/Roche and Envivo Pharmaceuticals

Molecular Diagnostics

Clinical Data

CombiMatrix

Curidium Medica

Roche/Affymetrix

Vanda Pharmaceuticals

Diagnostic Imaging

Outlook

Appendix A. Thought Leaders Consulted for This Report

Appendix B. Bibliography

Expert Commentaries

What Do Thought Leaders Say About the Potential Use of Biomarkers in Psychiatric Diagnosis and Treatment?

Carlos Dedesma, Analyst, Decision Resources, Inc.

The Potential for rEEG to Create Win-Win Situations for Stakeholders

Leonard Brandt, CEO, CNS Response

Disentangling Patient Populations to Develop More-Effective Drug Therapies

Anne T. Bruinvels, Ph.D., Founder and CSO, Curidium Medica

Sidebar

510(k) vs. PMA

Tables

1. Diagnostic Collaborations in Psychiatric Indications, 2004-March 2008

2. Roche’s AmpliChip CYP450 Test: Summary of Attributes

3. Major Opportunities and Challenges for Psychiatric Diagnostics

A. Drug Development Benefits by Development Phase

Figures

1. How Diagnostic Technologies Can Increase Treatment Effi cacy

2. Referenced-EEG Sample Report to Physicians from CNS Response

A. Medications Predicted by rEEG

B. Schematic Overview of the Studies Undertaken by Curidium to Identify a Blood Diagnostic Tool to Select Schizophrenia and Bipolar Disorder Patient Subgroups in the Clinic

Abstract

The diagnosis of psychiatric diseases is an inexact science and a slow process for physicians. No laboratory tests are available to determine the exact disease-or treatment. New diagnostic technologies could offer earlier, more specific diagnosis of a psychiatric disease and even direct potential drug therapy. In this report, we discuss the treatment challenges that confront physicians and patients and review current and emerging diagnostic tests that are expected to change the way in which psychiatric diseases are diagnosed. This report also features three Expert Commentaries, two offering input from the diagnostic technology industry, and one highlighting Decision Resources' primary research with physicians who discuss their views of biomarkerbased diagnostic tests for psychiatry.

Get the Answers You Need to Shape Your Strategy

• The diagnosis of mental illness is far from an exact science, with no laboratory tests to confirm a disorder or offer treatment strategies. What technologies are emerging that will expedite diagnosis and treatment of psychiatric disorders? How will these technologies affect R&D within the pharmaceutical industry?
• EEG, molecular, genetic, and imaging diagnostics are all poised for use in the field of psychiatry. How will the technologies that exist to aid diagnosis expand into the field of mental health? What companies already have clinical trials under way and what diagnostic tools are they using? How will these studies target patient response to some of today's most popular psychiatric drugs? What challenges do manufacturers face when developing these diagnostics?
• Expert Commentaries: two company executives and one market analyst discuss the impact of novel diagnostics in the psychiatric arena. What are thought leaders saying about the potential for biomarkers in mental health diagnosis and treatment? How will a new EEG tool help psychiatrists target drug therapy in their patients? How can gene-expression profiles lead to differential diagnoses or offer insight into disease-specific subtyping?

Scope

• Difficulties diagnosing mental illness : addressing similar symptomatology; multiple mental illnesses in one patient; challenges in determining optimal treatment; current medical practice for psychiatric indications.
• Current and emerging diagnostic technologies for psychiatric indications: EEG (Aspect Medical Systems, CNS Response, Memory Pharmaceuticals/Roche); molecular diagnostics (Clinical Data, CombiMatrix, Curidium Medica, Roche/Affymetrix, Vanda Pharmaceuticals); diagnostic imaging (Alseres).
• Psychiatric disorders: attention-deficit/hyperactivity disorder; autism spectrum disorder; bipolar disorder; major depression; schizophrenia; psychotic disorders.
• Business considerations: review of partnerships and licensing activities; benefits of drug/ theranostic codevelopment; challenges and opportunities.

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