Novel Approaches to Diagnosing Pulmonary Diseases

Published by: Decision Resources

Published: Jun. 26, 2007 - 36 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Overview

Disease Overview

Infectious Respiratory Disease

Obstructive Lung Disease

Lung Cancer

Current Diagnostics for Pulmonary Diseases

Infectious Respiratory Disease

Obstructive Respiratory Disease

Lung Cancer

Novel Biomarkers in Pulmonary Diseases

Biomarker for Respiratory Tract Infection

Novel Exhaled Biomarker in Obstructive Lung Disease

Biomarkers for Use with Therapeutics for Non-Small-Cell Lung Cancer

New Technologies for Infectious Respiratory Diagnosis

Multiplex Assays

Microarrays

Key Players in Infectious Respiratory Diagnostics

Becton Dickinson

CombiMatrix

Genaco Biomedical Products

Inverness Medical Innovations

Luminex/Tm Bioscience

Prodesse

Quidel

Remel

ZymeTx

Key Players in Innovative Diagnostics for Lung Cancer

20/20 Gene Systems

Epigenomics

Genzyme Genetics

Monogram Biosciences

Rosetta Genomics

Outlook

Viral Respiratory Disease

Obstructive Lung Disease

Lung Cancer

Spectrum Expert Commentary

Differential Diagnosis of Asthma and COPD: Increase PCP Awareness for Accurate

Diagnosis and Optimal Treatment

Tables

1. Pulmonary Diseases Covered in This Report

2. Diagnostics Currently Available for Viral Respiratory Diseases

3. Select Companies Marketing Pulmonary Diagnostic Devices for COPD, Asthma, and Emphysema

4. Novel Biomarkers for Diagnosis/Prognosis of Pulmonary Diseases

5. Select Companies Developing Innovative Diagnostics for Lung Cancer

6. Select Companies with Rapid Diagnostic Products for Viral Respiratory Diseases

7. Molecular Diagnostics for Detection of Multiple Respiratory Viruses

Figures

1. Common Infectious Respiratory Diseases

2. Non-Small-Cell Lung Cancer Risk Factors

3. Improvements in COPD Diagnosis Is a Clear Unmet Need

Abstract

• Target-enriched multiplex-PCR is a novel assay approach being evaluated for the identifi cation of infl uenza A and SARS. This innovative technology uses an automated system to generate results and screens multiple targets in a single sample in just hours. What company currently markets a product that can screen for more than 20 bacterial and viral respiratory pathogens?
• In December 2006, Quidel announced it had gained the exclusive, global license to the University of Colorado and the CDC’s technology for the MChip microarray-based infl uenza detection technology. What advantages does the MChip technology hold over other microarray technologies? How does Quidel plan to develop and market the MChip?
• The market for molecular diagnostics for lung cancer is robust and increasingly focused on developing bio- markers that can help identify which patients will prove most responsive to particular, individual therapies. Which company continues to develop a biomarker test already shown to predict non-small-cell lung cancer with 85% accuracy? Which other companies have clinical results forthcoming for a potential biomarker diagnostic to be used alongside a therapeutic that has already proved effective in non-smallcell lung cancer?
• The potential for the avian infl uenza virus to mutate into human variants has created the concern that a pan- demic may develop. Which companies are seeking approval to include identifi cation of the H5N1 avian infl uenza virus in their rapid, point-of-care immunoassay tests?
• In December 2006, the CDC awarded four grants to companies developing assays for diagnosing avian infl u- enza H5N1 (and other potential infl uenza viruses) in rapid, 30-minute tests. Which companies received these grants? What are the rapid diagnostic products these companies are developing?

• Overview of pulmonary diseases: causes, symptoms, impacts, and currently favored diagnostics for infectious respiratory disease, obstructive respiratory disease, and lung cancer.
• Novel biomarkers in pulmonary diseases: procalcitonin (respiratory tract infection), fractional exhaled nitric oxide (obstructive lung disease), EGFR mutations and RXR-beta (non-small-cell lung cancer).
• New technologies for infectious respiratory diagnosis: target-enriched multiplex polymerase chain reaction assays, multiplex reverse-transcriptase-PCR assays, and microarrays.
• Key players in infectious respiratory diagnostics: rapid tests and new technologies from nine leading companies in the fi eld of diagnostic products for infectious respiratory viruses.
• Key players in innovative diagnostics for lung cancer: new molecular diagnostics from five leading companies.
• Outlook: the promise of multiplex and microarray molecular diagnostics; the move toward portable spirometric devices and the increased use of spirometry for lung disease; the increasingly critical role of biomarkers in lung cancer diagnostics and therapeutics; the focus on the codevelopment of targeted therapies with biomarkers that identify patients who will be the most responsive to specifi c lung cancer therapies.
• Expert commentary: a detailed examination of the differential diagnosis of asthma and COPD, written by Regina E. Cebula, M.S., B.A., analyst for Decision Resources, Inc.

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