FDAnews Drug Daily Bulletin

FDA SOLICITS DNA STUDY DATA TO DEVELOP BIOMARKERS

May 1, 2006
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The FDA is soliciting data from deoxyribonucleic acid (DNA) studies and seeking proposals to analyze this data to further the agency's development of biomarkers, a recent Federal Register notice says. Submissions are due by May 31.

The FDA wants to determine the best way to develop biomarkers as part of its effort to promote personalized medicine under the Critical Path initiative. Personalized medicines are developed to treat certain subsets of the population based on their particular genetic makeup. These new medicines are considered by both the FDA and industry to be the wave of the future, taking the place of traditional treatments. Biomarkers are indicators of normal biological processes that show how well a particular treatment will work.

However, before such medicines can be developed, the agency needs to analyze how DNA microarray data is assessed to ensure the data is reliable, the notice says. A microarray is a tool for analyzing gene expression. It consists of a small membrane or glass slide containing samples of many genes arranged in a regular pattern. DNA microarray is a collection of microscopic DNA spots attached to a solid surface, such as glass, plastic or silicon chip forming an array.

The notice is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/nctr061-n000001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/nctr061-n000001.pdf).