Abstract
Introduction
Each of the three broad pulmonary disease areas-infectious respiratory
disease, obstructive respiratory disease, and lung cancer-has its favored 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 fi eld 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 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 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 infl uenza virus to mutate into human variants
has created the concern that a pandemic 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 uenza 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?
Scope
- 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 fi ve 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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