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Quest Gets NY State OK for CGH Post-natal Test

NEW YORK (GenomeWeb News) – Quest Diagnostics has received clinical laboratory approval from New York State for its ClariSure microarray-based comparative genomic hybridization post-natal test.

The ClariSure aCGH test was approved as an aid in detecting copy-number chromosomal abnormalities implicated in dozens of medical conditions including mental retardation, birth defects, and autism spectrum and developmental disorders, the Madison, NJ-based clinical lab firm said.

Quest said that with approval from the State Department of Health Clinical Laboratory Evaluation Program, Quest operates one of only three laboratories in the US approved to perform aCGH testing on postnatal samples collected on patients in New York.

"Since its launch in mid-2007, physicians outside of New York have used our ClariSure test to identify the genetic etiology of congenital anomalies, autism, and other disorders for dozens of patients whose conditions had eluded prior diagnostic efforts," said Charles Strom, medical director of the genetic testing center of Quest Diagnostics Nichols Institute, in a statement. "We look forward to providing broader access to our ClariSure test, so that more parents have the diagnostic insights they need to provide appropriate schooling and social support to their infants and children."

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