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 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?
Scope
Overview of pulmonary diseases: causes, symptoms, impacts, and currently favored diagnostics for
infectious respiratory disease, obstructive respiratory disease, and 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.
(0 items)
