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Title: New Test May Accurately Measure Patients' Response to Cystic Fibrosis Therapy
URL: http://www.pslgroup.com/dg/23153E.htm
Doctor's Guide
October 24, 2008

DENVER -- October 24, 2008 -- Researchers have identified a simple gene-based blood test that more accurately and quickly measures cystic fibrosis patients' response to therapy than current tests. The article is published in the November 1 issue of American Journal of Respiratory and Critical Care Medicine.

The test, a measure of inflammatory gene expression, could improve patient care and help clear a backlog of promising medications now hung up in clinical trials.

"The currently accepted test…has several limitations that make it ineffective for some patients and not sensitive enough for clinical trials of many new medications," said lead author Milene Saavedra, MD, National Jewish Health, Denver, Colorado.

"By measuring the activity of genes associated with the immune/inflammatory response, we can get a more accurate picture of the biological processes occurring inside the lungs."

The researchers thought white blood cells might be a good source of biomarkers for a more sensitive and accurate test. They evaluated 18 patients with cystic fibrosis (CF) who were suffering severe exacerbations. Blood was withdrawn from the patients before and after 2 weeks of intravenous antibiotic therapy. The severe exacerbation and antibiotic therapy served as a condensed model of illness and response to therapy.

Using microarray gene analysis of the blood samples, the researchers identified 10 genes that differed significantly in their expression before and after therapy. Using real-time polymerase chain reaction and additional statistical tools, the researchers identified 3 of those genes that most accurately correlated with a positive therapeutic response: CD36, CD64, and ADAM9.

"The expression of these genes correlated with FEV1 and various clinical factors," said coauthor Jerry Nick, MD, National Jewish Health. "When combined with FEV1, they offered a more accurate and sensitive measure of response to therapy than either alone. We believe they could be extremely useful in clinical care of patients and trials of new CF therapies."

The researchers are now conducting a trial of 60 patients with CF to provide stronger statistical evidence for the power of CD36, CD64 and ADAM9 to diagnose a positive response to therapy by CF patients.

SOURCE: National Jewish Health

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