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Novel Approaches to Diagnosing Pulmonary Diseases
Decision Resources, Inc., June 2007, Pages: 36


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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.



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