GGC Technologist First in US to Receive Certification

Amy Shearer, a laboratory technologist in the Greenwood Genetic Center’s Microarray Laboratory, is the first professional in the United States to be certified in CytoScan® Dx Assay testing. CytoScan® Dx Assay is the only microarray testing to gain FDA approval. Using a single blood sample, this test can scan a patient’s entire genome for the cause of developmental delays, intellectual disabilities and congenital anomalies.

“It can be such a difficult journey for families in search of an answer for their child’s challenges, and we are so excited at GGC to be able to offer this testing that can get at the root of the problem through a single test,” shared Shearer. “Once we understand the cause it can leads to possible therapies and interventions to improve their quality of life.”

Shearer, who has been with GGC since 2008, completed an intensive training program through Affymetrix, the company who developed CytoScan® Dx Assay, to ensure quality control of all samples tested in GGC’s laboratory. She has also trained other technologists in the lab. GGC’s microarray laboratory worked closely with Affymetrix in the clinical validation studies that lead to the eventual approval of the FDA for this test and GGC’s distinction of being the first lab in the US to offer this new testing.

“FDA approval is an important step for patients and clinicians to have the utmost confidence in the testing that is being performed,” shared Alka Chaubey, Director of GGC’s Cytogenetics Laboratory. “Our patients want to know that their test is held to the highest standards and the technologists running the test are well-trained in the complex technologies.”

CytoScan® Dx Assay is clinically available to patients and, per FDA guidelines, must be performed in a laboratory with certified personnel and interpreted by board certified clinical cytogeneticists. The lab currently analyzes approximately 1,500 microarray clinical samples per year.

Photo caption: Amy Shearer loading the Affymetrix CytoScan® Dx microarray chip in the Affymetrix GeneChip Scanner 3000Dx v.2