BCR-ABL Drug Resistance Analysis
| Order Code: | BCRSQ |
| Epic Lab Code: | LAB7394 |
| Order Form: | A-1a Miscellaneous Request or Epic Req |
Commercial Mail-out Laboratory
6240 RCP
356-3527
6240 RCP
356-3527
Specimen:
Whole Blood or Bone Marrow
Collection Medium:
 | and | |
| Pink top tube | Pink top tube |
Minimum:
Adult 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.
Delivery Instructions:
Deliver to laboratory immediately after collection.Analytic Time:
8 working 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
This test does sequence analysis of the BCR- ABL gene expressed in CML to determine if mutations are present that confer resistance to tyrosine kinase inhibitors such as imatinib (Gleevec), nilotinib (Tasigna), and dasatinib (Sprycel). THIS IS NOT THE TEST TO MAKE THE INITIAL DIAGNOSIS OF CML. The typical indication for this test is a patient with CML who has stopped responding to tyrosine kinase inhibitor therapy.
MolecularMD has developed a sensitive and specific direct sequencing assay for screen of mutations in BCR-ABL. Our assay detects mutations between amino acids 30 and 510 including the kinase domain SH3, SH2 and regions 3' to the ABL kinase domain.
Over 40 amino acid substitutions in the tyrosine kinase domain of BCR- ABL can be detected by MolecularMD's sequencing assay. These substitutions have been identified in CML patients who develop resistance to tyrosine kinase inhibitors and related treatments.
Direct sequencing is a non-biased approach that has a sensitivity of
20-30% in the identification of BCR-ABL mutant clones.
Limit of Detection: 20-30% of the mutant allele among non-mutated alleles
Controls: BCR-ABL WT and various mutants covering the entire kinase domain
Reporting: Amino acid change in ABL kinase domain
Phase: Chronic, Acute or Blastic
Diagnosis: New Dx, Relapse, Monitoring, Minimal Residual Disease(MRD)
Treatment: Untreated, Gleevec, Sprycel, Tasigna, Bone Marrow Transplant (BMT), Other
This test does sequence analysis of the BCR- ABL gene expressed in CML to determine if mutations are present that confer resistance to tyrosine kinase inhibitors such as imatinib (Gleevec), nilotinib (Tasigna), and dasatinib (Sprycel). THIS IS NOT THE TEST TO MAKE THE INITIAL DIAGNOSIS OF CML. The typical indication for this test is a patient with CML who has stopped responding to tyrosine kinase inhibitor therapy.
MolecularMD has developed a sensitive and specific direct sequencing assay for screen of mutations in BCR-ABL. Our assay detects mutations between amino acids 30 and 510 including the kinase domain SH3, SH2 and regions 3' to the ABL kinase domain.
Over 40 amino acid substitutions in the tyrosine kinase domain of BCR- ABL can be detected by MolecularMD's sequencing assay. These substitutions have been identified in CML patients who develop resistance to tyrosine kinase inhibitors and related treatments.
Direct sequencing is a non-biased approach that has a sensitivity of
20-30% in the identification of BCR-ABL mutant clones.
Limit of Detection: 20-30% of the mutant allele among non-mutated alleles
Controls: BCR-ABL WT and various mutants covering the entire kinase domain
Reporting: Amino acid change in ABL kinase domain
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:
Direct Sequencing
CPT Code:
83902, 83913, 83898(x5), 83896(x2), 83890, 83904(x4)
See Additional Information:
Specimens Requiring Immediate Delivery
Specimens Requiring Immediate Delivery