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Leukemia remission test gains regulatory clearance
December 2018
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PORTLAND, Ore. & CAMBRIDGE, Mass.—Health Canada recently granted regulatory approval to MolecularMD Corporation for its MRDx BCR-ABL Test, which was cleared by the FDA in late 2017. The quantitative diagnostic test is intended to help monitor treatment with tyrosine kinase inhibitors in patients with Philadelphia chromosome-positive chronic myeloid leukemia, and to identify patients in the chronic phase who are receiving Tasigna capsules and who, after maintaining a deep molecular response of MR4.5, may qualify for treatment-free remission (TFR) and monitoring.
 
“This is an exciting milestone for the MRDx BCR-ABL Test, enabling it to become more broadly accessible to patients beyond the United States,” said Dan Snyder, CEO of MolecularMD. “The test ensures that physicians have the information needed to identify Tasigna-treated patients who meet the stringent eligibility criteria to attempt TFR and provides the robust sensitivity and accuracy necessary for monitoring minimal residual disease with confidence.”

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