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FDA Authorizes Marketing of First of Molecular Test to Help Monitor CML Therapy

July 26, 2016

The Food and Drug Administration (FDA) has granted de novo classification for the QuantideX qPCR BCR-ABL IS Kit (Asuragen Inc.), an in vitro nucleic acid amplification test that measures the amount of BCR-ABL in blood specimens from patients with chronic myeloid leukemia (CML).

CML is caused by a reciprocal translocation between the long arms of chromosomes 9 and 22, producing the Philadelphia chromosome and its constituent BCR-ABL1 fusion gene. An estimated 8220 people will be diagnosed with CML in 2016.

The QuantideX qPCR BCR-ABL IS Kit is the first FDA-cleared molecular test indicated for BCR-ABL1 monitoring in patients with CML who are receiving treatment with a tyrosine kinase inhibitor. The test is not indicated to diagnose CML.


Food and Drug Administration (FDA).
Evaluation of Automatic Class III Designation (De Novo) Summaries. QuantideX qPCR BCR-ABL IS Kit. Classification Order. July 22, 2016. Available at: click here. Accessed July 25, 2016.