MolecularMD is a world leader in molecular diagnostic testing for BCR-ABL related diseases and therapies. BCR-ABL molecular tests are generally performed to support the following clinical areas:
- Diseases: PH + Chronic Mylogenous Leukemia (CML), PH+ Acute Lymphocytic Leukemia (ALL)
- Drugs: BCR-ABL kinase inhibitors (imatinib, dasatinib, nilotinib)
Serial analysis of BCR-ABL mRNA levels by quantitative reverse transcription polymerase chain (QRT-PCR) during and/or after therapy (imatinib, nilotinib, dasatinib, or stem cell transplantation) accurately reflects the level of disease suppression and is an effective method for monitoring treatment efficacy. The importance of high quality, reproducible Q-RT-PCR for measuring BCR-ABL mRNA was recently emphasized by leaders in the field of CML1. MolecularMD results are standardized for the International Scale2 and plotted with respect to Major Molecular Response (MMR).
Test Specifications
| Reported Value: | BCR-ABL/ABL % on International Scale |
| Sample Type: | Peripheral blood, bone marrow |
| Platform: | QRT-PCR |
| Sensitivity: | 3 copies mRNA or 1.5 logs below MMR |
| Interassay Variability: | 2 fold above MMR, 3 fold below MMR |
MolecularMD has optimized the BCR-ABL quantitation test for rapid turn-around time, reproducibility and enhanced sensitivity. Our service allows detection down to three copies of mRNA or 1.5 logs below MMR with a variability of three fold or less. The assay has an entire dynamic range of 5 logs.
Click here to view BCR-ABL Quantitation Product Sheet (pdf, 108k).
1Kantarjian H, et al. Blood. 2008;111(4):1774-1780.
2Hughes T, et al. N Engl J Med. 2003;349(15):1423-1432
Over 40 amino acid substitutions have been identified within the ABL kinase domain of BCR-ABL. MolecularMD’s Kinase Domain Sequencing assay detects mutations between amino acids 30 and 510 including the domains SH3, SH2 and regions 3’ to the ABL kinase domain. This offers a non-biased approach that identifies potentially resistant mutations in a comprehensive manner.
Click here to view ABL Kinase Domain Sequencing Product Sheet (pdf, 87k).
Test Specifications
| Reported Value: | Amino Acid Change in ABL Kinase Domain |
| Sample Type: | Peripheral blood, bone marrow |
| Platform: | Direct Sequencing |
| Sensitivity: | 20% - 30% mutant in population of wild type |
Among the amino acid substitutions in the kinase domain of BCR-ABL that translate resistance to kinase inhibitor therapies, BCR-ABL T315I is the mutation that confers biological and clinical resistance to all existing therapies, including imatinib, dasatinib and nilotinib. MolecularMD offers a specific Fluorescence Resonance Electron Transfer (FRET) based assay which provides superior sensitivity allowing detection down to 10% of the T315I mutation in the presence of wild type.
Click here to view T315I FRET Detection Product Sheet (pdf, 119k)
Test Specifications
| Methodology: | FRET (Fluorescence resonance energy transfer) |
| Limit of Detection: | 10% of the mutant allele among non-mutated alleles |
| Controls: | BCR-ABL WT and T315I mutants |
| Reported Value: | T315I mutation or no T315I mutation in BCR-ABL tyrosine kinase domain |
| Sample Type: | Peripheral blood or bone marrow |
