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 |
Effective immediately, the T315I FRET assay is discontinued, please click for more information.