Novel Approaches to Diagnosing Pulmonary Diseases

Each of the three broad pulmonary disease areas—infectious respiratory disease, obstructive respiratory disease, and lung cancer—has its favoured set of diagnostic methods. However, current methods of diagnosing pulmonary diseases have not fully provided the necessary differential diagnoses in the areas of infectious respiratory diseases and obstructive lung diseases. In the respiratory detection realm, the field of molecular diagnostics has now begun creating an innovative niche, owing to its timely and cost-effective technologies, including multiplex and microarray assays. The development of simple, rapid biomarker tests may similarly increase the likelihood of more readily identifying patients with obstructive lung disease. Finally, numerous companies are developing innovative, biomarker-based diagnostic tests for detecting lung cancer at very early stages.

Get the Answers You Need to Shape Your Strategy

- Target-enriched multiplex-PCR is a novel assay approach being evaluated for the identification of influenza 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 influenza 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 biomarkers 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 influenza virus to mutate into human variants has created the concern that a pandemic may develop. Which companies are seeking approval to include identification of the H5N1 avian influenza virus in their rapid, point-of-care immunoassay tests?
- In December 2006, the CDC awarded four grants to companies developing assays for diagnosing avian influenza H5N1 (and other potential influenza viruses) in rapid, 30-minute tests. Which companies received these grants? What are the rapid diagnostic products these companies are developing?

Scope

- Overview of pulmonary diseases: causes, symptoms, impacts, and currently favoured 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 field 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 co-development of targeted therapies with biomarkers that identify patients who will be the most responsive to specifi 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. SHOW LESS READ MORE >

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

- 20/20 Gene Systems
- AB Biodisk
- Abbott Laboratories
- Acacia Research
- Advance Life Science Institute
- Aerocrine
- Affymetrix
- AstraZeneca
- BD Biosciences
- BD Diagnostics
- BD Medical
- Becton Dickinson
- Binax
- BioMerieux
- Biosite
- BioStar
- Biotec
- Cangen Biotechnologies
- CDX
- Cepheid
- Chemsensing
- Cholestech
- Chugai
- Clement Clarke International
- CombiMatrix Molecular Diagnostics
- Creative Biomedics
- Denka Seiken
- Digilab Bio
- Eli Lilly
- Epigenomics
- EraGen Biosciences
- Genaco Biomedical Products
- Genentech
- Genzyme Genetics
- HX Diagnostics
- Inverness Medical Innovations
- Iquum
- Jones Medical Instrument
- Laboratory Corporation of America
- Ligand Pharmaceuticals
- Luminex
- Medical International Research
- Medikro
- Merck KGaA
- Meridian Bioscience
- MesoScale
- Micro Medical
- Monogram Biosciences
- Nanogen
- NDD Medical Technologies
- Olympus
- OSI Pharmaceuticals
- Procter & Gamble
- Prodesse
- Puritan Bennett
- Qiagen
- Quidel
- Remel
- Roche
- Roche Diagnostics
- Rosetta Genomics
- SA Scientifi c
- SensorMedics
- Sibelmed
- Tm Bioscience
- Trinity Biotech
- Unipath
- US Genomics
- Viasys Heathcare
- ViroMed Laboratories
- Vitalograph
- ZymeTx