The FDA Authorized Test for TFR Initiation and Monitoring

The MRDx® BCR-ABL Test is a companion diagnostic for Chronic Myeloid Leukemia (CML) patients in the chronic phase (CP) being treated with Tasigna®* who may be candidates for treatment discontinuation and monitoring of treatment-free remission (TFR). Read our Press Release.

Monitoring of TFR requires the ability to accurately measure BCR-ABL transcripts to a depth, classified as MR4.5 (BCR-ABL/ABL ≤0.0032% International Scale).

The MRDx BCR-ABL Test has consistently demonstrated sensitivity in ENESTfreedom and ENESTop clinical studies to MR4.5. The MRDx BCR-ABL Test is based on real-time quantitative PCR and measures BCR-ABL transcripts (e13a2/b2a2 and/or e14a2/b3a2) from peripheral blood specimens in CML-CP Ph+ patients.

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*Tasigna is a registered trademark of Novartis AG