Austin, Texas 07/25/2016 Asuragen, Inc. today announced that it received premarket clearance from the U.S. Food and Drug Administration (FDA) for the QuantideX® qPCR BCR-ABL IS Kit for the monitoring of molecular response in Chronic Myeloid Leukemia (CML) patients. It is the first FDA-cleared diagnostic kit for use in CML management. The kit’s unparalleled sensitivity, reproducibility and simplicity provide clinicians and laboratorians with a unique tool for the robust and accurate assessment of disease clearance in patients, with the potential to help significantly improve the cost and standard of care for patients.
Industry’s First FDA Cleared BCR-ABL Kit has Unprecedented Sensitivity