Glyko launches FACE lysosomal disease screening test.
This article was originally published in The Gray Sheet
Executive Summary
GLYKO BIOMEDICAL BEGINS SALES OF FACE LYSOSOMAL DISEASE SCREEN following 510(k) clearance of the product on Nov. 3. The company says that the FACE (Fluorophore-Assisted Carbohydrate Electrophoresis) Urinary Carbohydrate Analysis Kit is the first FDA-cleared product for identification of "abnormal" carbohydrates associated with lysosomal diseases. The test can screen children for more than 25 lysosomal diseases, which stem from hereditary defects in the lysosomal enzymes that break down and recycle carbohydrates. The disorders, resulting from the accumulation in the body of incompletely degraded sugar chains, include Tay-Sachs, Gaucher's, Hurler and Hunter MPS diseases.