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MRDx BCR-ABL Test gets nod from FDA
February 2018
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PORTLAND, Ore. & CAMBRIDGE, Mass.—MolecularMD Corp. announced recently that it had received authorization from the FDA for its MRDx BCR-ABL Test as a companion diagnostic. The test aids in the identification of Philadelphia chromosome-positive chronic myeloid leukemia patients in the chronic phase who are being treated with Tasigna and may be candidates for treatment discontinuation and monitoring of treatment-free remission (TFR). TFR is a patient's ability to maintain major molecular response or deep molecular response after discontinuing Tasigna.
 
“This is a major advancement in CML treatment practice. The Tasigna label update represents a new milestone, which may significantly impact thousands of patients,” said MolecularMD CEO Dan Snyder. “The FDA-authorized MRDx BCR-ABL Test ensures that physicians have the information needed to identify patients that 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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