BioCentury
ARTICLE | Clinical News

CombiSNP Array for Pediatric Analysis regulatory update

July 28, 2014 7:00 AM UTC

CombiMatrix said the New York Department of Health granted conditional approval for CombiSNP Array for Pediatric Analysis, a chromosomal microarray analysis (CMA) test to identify development disorders in pediatric patients. CombiMatrix said it will be able to market the test in the state while the product is under Clinical Laboratory Reference System review, but declined to disclose when it expects the review to conclude. The test, which is already marketed in the other 49 states, covers over 300 recurrent microdeletion/microduplication syndromes as well as about 4,000 morbid or disease-associated genes. ...