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FDA Clears Affymetrix’s CytoScan Dx Assay

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today said it has cleared Affymetrix’s CytoScan Dx Assay for marketing in the US.

The assay can detect chromosomal variations that may be responsible for developmental delay or intellectual disability in children. The test analyzes an entire genome at one time and detects large and small chromosomal changes, based on a blood sample, FDA said.

The agency reviewed the assay through its de novo classification process, a pathway for some novel low- to moderate-risk medical devices. Affy filed for FDA clearance of the test in February 2013.

“This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing healthcare providers and parents to intervene with appropriate care and support for the child,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.

FDA said CytoScan Dx should not be used as a stand-alone diagnostic, or for pre-implementation or prenatal testing or screening. It also is not for use for populations screening or for detecting of or screening for acquired or genetic aberrations occurring after birth, such as cancer.

Yesterday at the JP Morgan Healthcare Conference, Affymetrix President and CEO Frank Witney said CytoScan sales were up 35 percent through the first three quarters of the year, and Affy's installed base for CytoScan in the post-natal market grew 40 percent in 2013.