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Asuragen BCR-ABL Kit Granted FDA Premarket Clearance

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted premarket clearance to the first BCR-ABL assay, a qPCR-based kit from Asuragen.

The QuantideX qPCR BCR-ABL IS kit is now the first FDA-cleared diagnostic kit for management of chronic myeloid leukemia, the company said in a statement. Tyrosine kinase inhibitors such as imatinib (Gleevex) can be effective in treating CML but require sensitive molecular disease monitoring. The Asuragen test was cleared with a limit of detection of MR 4.7/0.002 percent IS, or a 4.7 log molecular reduction from 100 percent International Scale.

The multiplex assay design, result reporting software, and direct reporting of patient results in IS values "significantly improves laboratory workflows relative to currently available testing solutions," Asuragen said in a statement.

The test was CE marked last year, and is cleared to run on the Applied Biosystems 7500 Fast DX Real-Time PCR instrument. The test is not intended to diagnose CML or for monitoring rare transcripts resulting from t(9;22), the firm also noted.