BCR-ABL RNA Quantitation
| Order Code: | BCRQT |
| Epic Lab Code: | LAB7393 |
| Order Form: | A-1a Miscellaneous Request or Epic Req |
Commercial Mail-out Laboratory
6240 RCP
356-3527
6240 RCP
356-3527
Specimen:
Whole Blood, Bone Marrow
Collection Medium:
 | and | |
| Pink top tube | Pink top tube |
Minimum:
10 mL whole blood (TWO pink top tubes) or 2 mL bone marrow (ONE pink
top tube)
Rejection Criteria:
Sample MUST be received at reference
laboratory within 48 hours of collection due to lability of
RNA.
Delivery Instructions:
Deliver to laboratory immediately after collection.Analytic Time:
5 days upon receipt at reference laboratory
Reference Range:
By report.
Comments:
Patient specific questions in Epic will need to be answered for
reference laboratory reporting:
Phase: Chronic, Acute or Blastic
Diagnosis: New Dx, Relapse, Monitoring, Minimal Residual Disease(MRD)
Treatment: Untreated, Gleevec, Sprycel, Tasigna, Bone Marrow Transplant (BMT), Other
Serial analysis of BCR-ABL mRNA levels by real-time quantitative polymerase chain reaction (QRT-PCR) during and/or after therapy (imatinib, dasatinib, nilotinib, or stem cell transplantation) accurately reflects the levels of disease suppression and is an effective method for monitoring treatment efficacy. The importance of high quality, reproducible QRT-PCR for measuring BCR-ABL mRNA was recently emphasized by leaders in the CML field.
Major Molecular Response (MMR) is an easily interpreted and consequential value that reflects a patient's response to CML treatment. MMR is defined as greater than or equal to 3-log reduction in BCR-ABL/control gene ratio from a standardized median baseline value. In the International Randomized Interferon versus STI571 (IRIS) study, patients with a ratio at or below MMR within 18 months of starting treatment were 100% free from progressing to accelerated phase or blast crisis at 60 months. MolecularMD employs a MMR reference value that has been validated with participants of the IRIS study.
MolecularMD BCR-ABL quantitation services allows accurate and reliable measurement of the BCR-ABL transcript and allows comparison of BCR-ABL levels to MMR. Quantitation of the transcript reflects the proportion of residual leukemia cells in the patient.
Interassay Variability: Above MMR: less than 2-fold, Below MMR: less than 3-fold
Sensitivity: One tumor cell in 1 x 106 normal cells
Limit of Quantitation: 3 BCR-ABL copies
Reporting: BCR-ABL/ABL ratio, MMR value, BCR-ABL copy number, ABL copy number, fold change from previous ratio
(Major Breakpoint b2a2, b3a2)
Phase: Chronic, Acute or Blastic
Diagnosis: New Dx, Relapse, Monitoring, Minimal Residual Disease(MRD)
Treatment: Untreated, Gleevec, Sprycel, Tasigna, Bone Marrow Transplant (BMT), Other
Serial analysis of BCR-ABL mRNA levels by real-time quantitative polymerase chain reaction (QRT-PCR) during and/or after therapy (imatinib, dasatinib, nilotinib, or stem cell transplantation) accurately reflects the levels of disease suppression and is an effective method for monitoring treatment efficacy. The importance of high quality, reproducible QRT-PCR for measuring BCR-ABL mRNA was recently emphasized by leaders in the CML field.
Major Molecular Response (MMR) is an easily interpreted and consequential value that reflects a patient's response to CML treatment. MMR is defined as greater than or equal to 3-log reduction in BCR-ABL/control gene ratio from a standardized median baseline value. In the International Randomized Interferon versus STI571 (IRIS) study, patients with a ratio at or below MMR within 18 months of starting treatment were 100% free from progressing to accelerated phase or blast crisis at 60 months. MolecularMD employs a MMR reference value that has been validated with participants of the IRIS study.
MolecularMD BCR-ABL quantitation services allows accurate and reliable measurement of the BCR-ABL transcript and allows comparison of BCR-ABL levels to MMR. Quantitation of the transcript reflects the proportion of residual leukemia cells in the patient.
Interassay Variability: Above MMR: less than 2-fold, Below MMR: less than 3-fold
Sensitivity: One tumor cell in 1 x 106 normal cells
Limit of Quantitation: 3 BCR-ABL copies
Reporting: BCR-ABL/ABL ratio, MMR value, BCR-ABL copy number, ABL copy number, fold change from previous ratio
(Major Breakpoint b2a2, b3a2)
Test
Limitations:
Ambient: 1 hour (Samples must be refrigerated
within one hour and reach the reference laboratory within 48 hours of
draw time-due to lability of RNA).
Methodology:
Quantitative real-time Polymerase Chain Reaction
CPT Code:
83902, 83913, 83898(x4), 83896(x4), 83890
See Additional Information:
Specimens Requiring Immediate Delivery
Specimens Requiring Immediate Delivery