Affymetrix, Inc. (NASDAQ: AFFX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its CytoScan® Dx Assay. This assay is intended for the postnatal detection of DNA copy number variants (CNV) in patients referred for chromosomal testing. CytoScan Dx Assay is designed to help physicians diagnose children's developmental and intellectual disabilities more comprehensively by enabling a high-resolution genome-wide analysis of genetic aberrations. High resolution analysis can reveal small aberrations not readily seen using traditional techniques.
"This clearance is first-of-its-kind, and represents a leap forward in molecular genetic testing. CytoScan Dx Assay is the first FDA-cleared test that analyzes the whole genome in a single assay at unprecedented resolution, which significantly improves diagnostic capability. Developing and clearing this assay establish Affymetrix as a leader in advancing molecular diagnostics by bringing high quality genomic tools into routine application in the clinic," said Frank Witney, CEO and President of Affymetrix. "We expect to be making CytoScan Dx Assay available to laboratories within the US in the next few months. In addition, the clearance by the FDA is an important milestone for supporting adoption in other key countries around the world where they are now evaluating advanced tools and tests like this."
"We are pleased to have been selected by Affymetrix to be part of the clinical trial for CytoScan Dx Assay and found the performance data of this assay very impressive. With two to three percent of children in the United States having some form of developmental delay or intellectual disabilities, finding a diagnosis for the patient and their family can become a lengthy odyssey. This assay represents the best option for accelerating an accurate diagnosis," said Alka Chaubey, PhD, Director of the Greenwood Genetic Center's Cytogenetics Laboratory.
