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

Cytogenetic abnormalities commonly associated with chronic myelogenous leukemia (CML) and CML in transformation are detected by fluorescence in situ hybridization (FISH). Probes for Cen 8 (+8), BCR/ABL1-ASS1 t(9;22), RARA (17q21.2)/(iso17q) are included in the CML FISH Profile.

Quantitative real-time polymerase chain reaction (PCR) is used to detect the t(9;22) BCR-ABL1 fusion transcripts that result in major (p210), minor (p190), or micro (p230) fusion proteins. Minimal residual disease monitoring results for the major breakpoint transcripts are reported and graphed on the International Scale (IS). Monitoring results for the minor and micro breakpoints transcripts are reported.

Detects ABL1 kinase domain mutations in patients with BCR-ABL1-positive chronic myelogenous leukemia (CML) or acute lymphoblastic leukemia (ALL). RNA is isolated, reverse transcribed to complementary DNA (cDNA), and the DNA sequence of targeted regions of ABL (exons 4, 6-7) is determined using next-generation sequencing (NGS) technology. Analysis includes detection of the common T315I mutation.

Cytogenetic abnormalities commonly associated with myeloproliferative neoplasms (MPN) are detected by fluorescence in situ hybridization (FISH). Probes for CKS1B-CDKN2C (1p32.3/1q21.3), 5q (5q-/-5/+5), 7q (7q-/-7), Cen 8 (+8), BCR/ABL1-ASS1 t(9:22), 13q (13q-/-13), 20q (20q-) are included in the MPN FISH Profile