Chronic Myeloid Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) is a myeloproliferative neoplasm characterized by a balanced genetic translocation between the Abelson (ABL) oncogene on chromosome 9 and breakpoint cluster region (BCR) on chromosome 22 t(9;22)(q34;q11). The deriving shorter chromosome 22 is termed the Philadelphia chromosome with a chimeric BCR-ABL gene that varies in size, depending on the breakpoint in the BCR gene. Patients with BCR-ABL Major breakpoint translocation are diagnosed by the formation of BCR-ABL fusion gene that encode for a p210 protein. b2a2 and b3a2 are the most common fusion gene variants for BCR-ABL Major. The encoded p210 protein has an elevated tyrosine kinase activity that is implicated with the pathogenesis of the disease.¹

Reference:

1) Pane F, Intrieri M, Quintarelli C, Izzo B, Muccioli GC, Salvatore F. BCR/ABL genes and leukemic phenotype: from molecular mechanisms to clinical correlations. Oncogene 21. 2002;8652–67.

The Sentosa SA BCR-ABL Major Quantitative RT-PCR Test is a single-plex, real-time polymerase chain reaction (PCR)-based in vitro diagnostic test. This test is intended for use for nucleic acid extraction from peripheral blood samples on the Sentosa SX101 automated extraction and pipetting system, with the Sentosa SX Total RNA Kit and the Rotor-Gene Q MDx 5plex HRM instrument for in vitro quantitation of BCR-ABL Major fusion gene transcripts in leukemia patients who have been diagnosed with BCR-ABL Major b2a2 and b3a2 translocations.

The test can be used at a prognostic stage to observe the drug treatment effects or as a supplementary approach for diagnosis. It should not be used as the sole basis to make diagnostic decisions. Results from Sentosa SA BCR-ABL Major Quantitative RT-PCR Test should be interpreted within the context of all relevant clinical and laboratory findings.

Supporting Clinical Decision Making

• Referenced to WHO International Standards (BCR-ABL Major)
• Linear Range
  • BCR-ABL Major: 0.0027% IS to 15% IS BCR-ABL
  • BCR-ABL minor : 0.0089% to 50% BCR-ABL minor/ABL
• LoD:
  • BCR-ABL Major: 0.0026% IS BCR-ABL
  • BCR-ABL minor: 0.0026% BCR-ABL minor/ABL

Providing Laboratory Effectiveness

• Automated extraction and PCR set-up
• Elimination of tedious and error prone steps

Increasing Cost Effectiveness

• Less than 25% of entire workflow require hands-on time

For availability in your country, please contact your Vela Diagnostics sales representative.