QuantideX® qPCR BCR-ABL IS Kit - FDA Cleared

There’s only one way to detect complete molecular response (CMR) – with a more sensitive assay. The QuantideX® qPCR BCR-ABL IS Kit takes chronic myeloid leukemia (CML) monitoring to a new level of sensitivity – 0.002% IS (MR4.7). It’s a qPCR-based in vitro Diagnostic test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.

Reduced Complexity Ease-of-data analysis and reporting:

  • Direct reporting on the International Scale (IS): No sample exchange or conversion factor calculations required
  • Data analysis software eliminates manual intervention to provide automated calculations and streamlined reporting

Optimized Workflow Valuable operator hands-on time has been significantly reduced through:

  • Multiplexed assay design that amplifies and detects both fusion and control gene in the same reaction
  • All-inclusive reagents sourced and Quality Controlled together from a single vendor
  • Pre-mixed tubes leading to fewer pipetting steps in the mastermix preparation 

Quality Performance Detecting BCR-ABL Transcripts robustly, reliably with a highly sensitive assay:

  • Sensitivity of MR4.7 (0.002%IS): 95% positivity at this LOD as determined by testing human RNA specimens
  • Increased sensitivity without compromising specificity: Non-CML (major) transcripts not detected by the assay
  • Armored RNA based standards providing true RNA quantification for a quantitative RNA assay
  • Robust performance as indicated by minimum variability of replicate measurements