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Quest Diagnostics Introduces ClariSure(TM) Test for Identifying Chromosome Abnormalities Associated With 85 Developmental Disorders in Children
Date:8/30/2007

se a single blood specimen to identify chromosomal abnormalities associated with up to 85 developmental disorders. A positive result may be confirmed using a licensed fluorescence in situ hybridization (FISH) methodology. The company expects to provide test results from its ClariSure assay to physicians within five days of receiving a specimen at a Quest Diagnostics laboratory.

"While CGH microarrays often are used for research purposes, the considerable expertise and development required to commercialize these technologies has limited their use for diagnostic testing," said Joyce Schwartz, M.D., vice president and chief laboratory officer. "Our ClariSure assay bridges the gap between scientific research and real-world testing, affording physicians with a faster technique for diagnosing patients suspected of having a developmental disorder. With better diagnostic insights, parents can provide their child with appropriate schooling and social support, and understand the likelihood that other offspring may have the same disorder."

Quest Diagnostics owns the intellectual property underlying its microarray technology, which is used to analyze information contained within an individual's genetic makeup. CGH microarray technologies compare and contrast a specimen's DNA to the DNA of a healthy individual to identify, at a high resolution, extra or missing genetic material in the specimen. These technologies can detect a substantial proportion of additional abnormalities even in patients who have already had extensive cytogenetic and/or fluorescence in situ hybridization testing.(2) CGH microarray technologies are also more efficient, as multiple FISH tests are required to generate the same amount of information produced from one microarray-based test.

Quest Diagnostics' ClariSure test will be first introduced to physicians at pediatric and children's hospitals, with an emphasis on pediatricians, geneticists and pediatric neurologists.

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