MolecularMD Withdraws PMA for Leukemia CDx | GenomeWeb

NEW YORK (GenomeWeb News) – MolecularMD and Ariad Pharmaceuticals today said that MolecularMD has withdrawn its premarket approval application to the US Food and Drug Administration for its BCR-ABL T315I Mutation Test.

MolecularMD's test detects the BCR-ABL T315I mutation in chronic myeloid leukemia and Philadephia-chromosome positive acute lymphoblastic leukemia patients and was intended as a companion diagnostic for Ariad's investigational BCR-ABL inhibitor, ponatinib, currently being reviewed by FDA.

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