GGC first lab to offer FDA-cleared array

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The Greenwood Genetic Center (GGC) recently announced that it is the first laboratory in the U.S. to offer Affymetrix’s CytoScan Dx Assay, an FDA-cleared chromosomal microarray analysis (CMA).

The product became the first and only CMA to gain clearance by the US Food and Drug Administration (FDA) in January. Using a single blood sample, CytoScan Dx Assay can scan a patient’s entire genome for the cause of developmental delays, intellectual disabilities and congenital anomalies.

California-based Affymetrix Inc. partnered with GGC and other laboratories to conduct clinical trials to demonstrate the safety and effectiveness of the assay.

Additionally, GGC provided more than half of the 960 clinical samples used for the clinical validation component of the studies. Their findings showed that this CMA technology had improved ability to detect certain chromosomal abnormalities over other commonly used tests, including standard chromosome testing.

The GGC Cytogenetics Laboratory, supervised by Drs. Chaubey and DuPont, will offer CytoScan Dx Assay.

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