FDA Clears Asuragen's BCR-ABL Kit

Asuragen, Inc. has 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.

About 10% of all leukemia is CML.  Targeted treatments like imatinib (Gleevec) and other tyrosine kinase inhibitors (TKIs), have significantly increased the CML 5-year survival rate. With improved therapies, highly sensitive disease monitoring at the molecular level is an important part of patient management.   Despite the long-established importance of BCR-ABL1 monitoring in successful CML therapy, until now there has been no FDA-cleared BCR-ABL1 monitoring assay available to patients and physicians.

The highly sensitive QuantideX® qPCR BCR-ABL IS assay was subjected to extensive analytic and clinical review through the FDA’s de novo 510(k) premarket review pathway and secured clearance with a limit of detection (LOD) of MR4.7 / 0.002% IS (4.7 log molecular reduction from 100% IS).  The LOD was determined using real human RNA, not human-derived cell lines, ensuring that even at this unprecedented analytical sensitivity, the assay reproducibly detects BCR-ABL1 RNA in ≥95% of patients at MR 4.7.  Additionally, the combination of multiplex assay design, result reporting software and the ability to directly report patient results in IS values significantly improves laboratory workflows relative to currently available testing solutions. The kit was cleared to run on the Applied Biosystems® 7500 Fast DX Real-Time PCR Instrument.

“In evaluating the QuantideX® qPCR BCR-ABL IS kit, we confirmed the high level of sensitivity achieved for human clinical samples measured in our laboratory at MR 4.7 (0.002% IS). The configuration of the assay – multiplexed, single-lot reagents, efficient workflow, and direct IS reporting – provided the robustness, sensitivity and data quality we believe to be unprecedented in the market today,” said Y. Lynn. Wang, MD, PhD, FACP, Professor and Founding Division Director, Genomic and Molecular Pathology, University of Chicago Comprehensive Cancer Center. “The high level of sensitivity will contribute to the assessment of the depth and duration of clinical response to TKI and experimental therapies.”

“The FDA clearance of the QuantideX® qPCR BCR-ABL IS kit demonstrates Asuragen’s focus on commercializing regulated molecular diagnostic products in oncology and genetic disease testing and monitoring” said Matthew McManus, MD, PhD, Asuragen’s President and CEO.  “We’re committed to improving patient care, here in CML, by providing highly sensitive, reliable and easy to use products.”