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Emerging Diagnostic Technologies for Use in Psychiatric Indications

Description:
Introduction

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 specifi c 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 biomarker based 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 confi rm 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 fi eld 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 profi les 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-defi cit/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.
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 Efficacy
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
Companies Mentioned
- Affymetrix
- Agilent Technologies
- Alseres
- Applera
- Applied Biosystems
- Aspect Medical Systems
- Biogen Idec
- Boston Life Sciences
- Bristol-Myers Squibb
- Cetus
- Clinical Data
- CNS Response
- CombiMatrix
- DNA Direct
- Envivo Pharmaceuticals
- Forest Laboratories
- Genaissance Pharmaceuticals
- Genelex
- Genentech
- GlaxoSmithKline
- Illumina
- Lundbeck
- Memory Pharmaceuticals
- Merck KGaA
- Navigenics
- Northstar Neuroscience
- Novartis
- Pfi zer
- PGxHealth
- Roche
- Vanda Pharmaceuticals
- Zenyaku Kogyo
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