Hematologic Diseases

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

MRDx® is a registered trademark of MolecularMD

disease state indication(s)
Chronic myelogenous leukemia (CML) with major breakpoint (p210), currently on TKI therapy or in treatment-free remission.

clinical use
The BCR-ABL MRDx® TFR Monitoring Test is intended to measure BCR-ABL mRNA transcript levels in patients diagnosed with t(9;22) positive CML during monitoring of treatment with tyrosine kinase inhibitors (TKIs). The device is also intended to be used in the serial monitoring for BCR-ABL mRNA transcript levels as an aid in identifying CML patients in the chronic phase being treated with nilotinib who may be candidates for treatment discontinuation and for monitoring of treatment-free remission. The test does not differentiate between (major breakpoint, p210) e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts (including minor and micro breakpoints, p190 and p230) resulting from t(9;22). The test is not intended for the diagnosis of CML.Treatment-free remission (TFR) or deep molecular response (DMR) after stopping tyrosine kinase inhibitor therapy (TKI) is an emerging treatment goal for patients with CML in chronic phase (CML-CP) The NCCN guidelines for CML indicate that discontinuation of TKI therapy is feasible in selected patients in the context of careful monitoring. Two single-arm phase 2 clinical trials (ENESTfreedom and ENESTop) have provided clinical evidence for treatment discontinuation, resulting in TFR selection and monitoring for patients who are prescribed nilotinib therapy.

methodology/product platform
Polymerase chain reaction (PCR)

specimen type and requirements
Peripheral blood: 10 mL (5 mL minimum) in EDTA (purple-top) tube. Blood tubes must be stored and transported at 2 to 8° C, with the RNA extraction being performed within 48 hours of collection.
Specimens must only be shipped to Genoptix Monday through Thursday.
Note: Use frozen cold pack for transport. Make sure cold pack is not in direct contact with specimen.
DO NOT FREEZE SPECIMEN.

turnaround time
7 Days

cpt code(s)
PLA CODE: 0040U

medicare moldx cpt code
Not applicable)

regulatory classification
FDA authorized

ordering option
Global (TC & PC)