A molecular diagnostic test that detects chromosome abnormalities associated with 85 developmental disorders affecting children now is commercially available from the U.S. Quest Diagnostics Incorporated.
Quest Diagnostics has developed ClariSure™ microarray-based comparative genomic hybridization (CGH) test to enable physicians to use results obtained from a single blood test to diagnose patients with mental retardation and dozens of other disorders, including Down, cri du chat, DiGeorge and Williams syndromes.
"Our ClariSure test is an important advance in diagnostic testing resulting from the Human Genome Project(1). This project gave us the map of the human genome and knowledge of DNA required to develop and commercialize our assay," said Charles (Buck) Strom, M.D., Ph.D., medical director of the genetic testing center of Quest Diagnostics Nichols Institute, the esoteric testing laboratory and research and development center of Quest Diagnostics.
"Using today's conventional analytical techniques, physicians may inadvertently miss the genetic cause of a patient's developmental disorder. Our ClariSure test is a powerful tool that physicians can use to produce an accurate diagnosis more quickly,” Storm continued.
The ClariSure test is a laboratory-developed assay that uses proprietary technologies from Nichols Institute as well as licensed methodologies. Scientists at Nichols Institute have validated the ClariSure test's ability to use 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.