Yes, if not ordered by Adult or Pediatric Hematology-Oncology
Available Stat
No
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 1x per week as needed, Monday or Wednesday, day shift only
Methodology
RT-PCR and DNA sequencing
Reported
7-10 days
Additional Information
Treatment of CML and ALL patients positive for BCR-ABL chromosomal translocation is aimed at the eradication of tumor cells carrying the BCR-ABL oncoprotein, which has increased tyrosine kinase activity. Treatment with Gleevec (imatinib mesylate) or other tyrosine kinase inhibitors (TKI's) may result in drug resistance caused by the development of mutations within the ABL kinase domain (KD) of the BCR-ABL oncoprotein. Early identification of these mutations, for example as a patient is monitored for minimal residual disease by PCR, may prevent clinical relapse and allow physicians to use alternative TKI's that could potentially eradicate leukemic clones carrying a specific ABL KD mutation. Specific ABL KD mutations have been determined to be either sensitive or resistant to imatinib, dasatinib, or ilotinib and therefore treatment modalities can be tailored based on a patient's specific mutation.
This test will detect leukemic clones carrying a BCR-ABL translocation at a level of 1 in 100,000 cells and will identify ABL KD mutations in that population when 20% or more of the cells contain the mutation.
The result is reported as negative or positive with the type of ABL KD mutation detected and whether it is present as a clonal expansion or on a background on non-mutated cells. Results are best interpreted during follow-up monitoring of the BCR-ABL to ABL ratio using the Quantitative BCR-ABL assay.
This test was developed and it's performance characteristics determined by the Clinical Laboratories at the UCSF Medical Center. it has not been cleared or approved by the U.S. Food and Drug Administration.
Reflex Testing
An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.
Synonyms
BCR-ABL mutations
BCR/ABL mutations
CML
Chronic myelogenous leukemia
Gleevec resistance
Iminitab mesylate resistance
Philadelphia chromosome
PH1 chromosome
breakpoint cluster region
Sample Type
EDTA Whole blood or bone marrow
Collect
Lavender top
Amount to Collect
Blood: 5 mL
Marrow: 2 mL
Preferred Volume
Blood: 5 mL
Marrow: 2 mL
Minimum Volume
Blood: 2 mL
Marrow: 1 mL
Remarks
Due to limited stability samples for this test should not be collected the day before a holiday or 3-day weekend.
Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
Stability (from collection to initiation)
Refrigerated 3 days.
Unacceptable Conditions
Samples collected in heparin
Test Code
KDSQ
Test Group
BCRABL
Performing Lab
Medical Genomics - Molecular Diagnostics
Specimen Preparation
Do not centrifuge. Refrigerate sample, DO NOT freeze.
Preferred Volume
Blood: 5 mL
Marrow: 2 mL
Minimum Volume
Blood: 2 mL
Marrow: 1 mL
Unacceptable Conditions
Samples collected in heparin
Stability (from collection to initiation)
Refrigerated 3 days.
Reference Interval
None detected
Additional Information
Treatment of CML and ALL patients positive for BCR-ABL chromosomal translocation is aimed at the eradication of tumor cells carrying the BCR-ABL oncoprotein, which has increased tyrosine kinase activity. Treatment with Gleevec (imatinib mesylate) or other tyrosine kinase inhibitors (TKI's) may result in drug resistance caused by the development of mutations within the ABL kinase domain (KD) of the BCR-ABL oncoprotein. Early identification of these mutations, for example as a patient is monitored for minimal residual disease by PCR, may prevent clinical relapse and allow physicians to use alternative TKI's that could potentially eradicate leukemic clones carrying a specific ABL KD mutation. Specific ABL KD mutations have been determined to be either sensitive or resistant to imatinib, dasatinib, or ilotinib and therefore treatment modalities can be tailored based on a patient's specific mutation.
This test will detect leukemic clones carrying a BCR-ABL translocation at a level of 1 in 100,000 cells and will identify ABL KD mutations in that population when 20% or more of the cells contain the mutation.
The result is reported as negative or positive with the type of ABL KD mutation detected and whether it is present as a clonal expansion or on a background on non-mutated cells. Results are best interpreted during follow-up monitoring of the BCR-ABL to ABL ratio using the Quantitative BCR-ABL assay.
This test was developed and it's performance characteristics determined by the Clinical Laboratories at the UCSF Medical Center. it has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Codes
81170
LDT or Modified FDA
Yes
Approval Required
Yes, if not ordered by Adult or Pediatric Hematology-Oncology
Available Stat
No
Test Code
KDSQ
Test Group
BCRABL
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 1x per week as needed, Monday or Wednesday, day shift only
Methodology
RT-PCR and DNA sequencing
Remarks
Due to limited stability samples for this test should not be collected the day before a holiday or 3-day weekend.
Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
Collect
Lavender top
Amount to Collect
Blood: 5 mL
Marrow: 2 mL
Sample Type
EDTA Whole blood or bone marrow
Preferred Volume
Blood: 5 mL
Marrow: 2 mL
Minimum Volume
Blood: 2 mL
Marrow: 1 mL
Unacceptable Conditions
Samples collected in heparin
Specimen Preparation
Do not centrifuge. Refrigerate sample, DO NOT freeze.
Reference Interval
None detected
Synonyms
BCR-ABL mutations
BCR/ABL mutations
CML
Chronic myelogenous leukemia
Gleevec resistance
Iminitab mesylate resistance
Philadelphia chromosome
PH1 chromosome
breakpoint cluster region
Stability (from collection to initiation)
Refrigerated 3 days.
Reported
7-10 days
Reflex Testing
An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.
Additional Information
Treatment of CML and ALL patients positive for BCR-ABL chromosomal translocation is aimed at the eradication of tumor cells carrying the BCR-ABL oncoprotein, which has increased tyrosine kinase activity. Treatment with Gleevec (imatinib mesylate) or other tyrosine kinase inhibitors (TKI's) may result in drug resistance caused by the development of mutations within the ABL kinase domain (KD) of the BCR-ABL oncoprotein. Early identification of these mutations, for example as a patient is monitored for minimal residual disease by PCR, may prevent clinical relapse and allow physicians to use alternative TKI's that could potentially eradicate leukemic clones carrying a specific ABL KD mutation. Specific ABL KD mutations have been determined to be either sensitive or resistant to imatinib, dasatinib, or ilotinib and therefore treatment modalities can be tailored based on a patient's specific mutation.
This test will detect leukemic clones carrying a BCR-ABL translocation at a level of 1 in 100,000 cells and will identify ABL KD mutations in that population when 20% or more of the cells contain the mutation.
The result is reported as negative or positive with the type of ABL KD mutation detected and whether it is present as a clonal expansion or on a background on non-mutated cells. Results are best interpreted during follow-up monitoring of the BCR-ABL to ABL ratio using the Quantitative BCR-ABL assay.
This test was developed and it's performance characteristics determined by the Clinical Laboratories at the UCSF Medical Center. it has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Codes
81170
LDT or Modified FDA
Yes
Ordering
Approval Required
Yes, if not ordered by Adult or Pediatric Hematology-Oncology
Available Stat
No
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 1x per week as needed, Monday or Wednesday, day shift only
Methodology
RT-PCR and DNA sequencing
Reported
7-10 days
Additional Information
Treatment of CML and ALL patients positive for BCR-ABL chromosomal translocation is aimed at the eradication of tumor cells carrying the BCR-ABL oncoprotein, which has increased tyrosine kinase activity. Treatment with Gleevec (imatinib mesylate) or other tyrosine kinase inhibitors (TKI's) may result in drug resistance caused by the development of mutations within the ABL kinase domain (KD) of the BCR-ABL oncoprotein. Early identification of these mutations, for example as a patient is monitored for minimal residual disease by PCR, may prevent clinical relapse and allow physicians to use alternative TKI's that could potentially eradicate leukemic clones carrying a specific ABL KD mutation. Specific ABL KD mutations have been determined to be either sensitive or resistant to imatinib, dasatinib, or ilotinib and therefore treatment modalities can be tailored based on a patient's specific mutation.
This test will detect leukemic clones carrying a BCR-ABL translocation at a level of 1 in 100,000 cells and will identify ABL KD mutations in that population when 20% or more of the cells contain the mutation.
The result is reported as negative or positive with the type of ABL KD mutation detected and whether it is present as a clonal expansion or on a background on non-mutated cells. Results are best interpreted during follow-up monitoring of the BCR-ABL to ABL ratio using the Quantitative BCR-ABL assay.
This test was developed and it's performance characteristics determined by the Clinical Laboratories at the UCSF Medical Center. it has not been cleared or approved by the U.S. Food and Drug Administration.
Reflex Testing
An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.
Synonyms
BCR-ABL mutations
BCR/ABL mutations
CML
Chronic myelogenous leukemia
Gleevec resistance
Iminitab mesylate resistance
Philadelphia chromosome
PH1 chromosome
breakpoint cluster region
Collection
Sample Type
EDTA Whole blood or bone marrow
Collect
Lavender top
Amount to Collect
Blood: 5 mL
Marrow: 2 mL
Preferred Volume
Blood: 5 mL
Marrow: 2 mL
Minimum Volume
Blood: 2 mL
Marrow: 1 mL
Remarks
Due to limited stability samples for this test should not be collected the day before a holiday or 3-day weekend.
Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
Stability (from collection to initiation)
Refrigerated 3 days.
Unacceptable Conditions
Samples collected in heparin
Processing
Test Code
KDSQ
Test Group
BCRABL
Performing Lab
Medical Genomics - Molecular Diagnostics
Specimen Preparation
Do not centrifuge. Refrigerate sample, DO NOT freeze.
Preferred Volume
Blood: 5 mL
Marrow: 2 mL
Minimum Volume
Blood: 2 mL
Marrow: 1 mL
Unacceptable Conditions
Samples collected in heparin
Stability (from collection to initiation)
Refrigerated 3 days.
Result Interpretation
Reference Interval
None detected
Additional Information
Treatment of CML and ALL patients positive for BCR-ABL chromosomal translocation is aimed at the eradication of tumor cells carrying the BCR-ABL oncoprotein, which has increased tyrosine kinase activity. Treatment with Gleevec (imatinib mesylate) or other tyrosine kinase inhibitors (TKI's) may result in drug resistance caused by the development of mutations within the ABL kinase domain (KD) of the BCR-ABL oncoprotein. Early identification of these mutations, for example as a patient is monitored for minimal residual disease by PCR, may prevent clinical relapse and allow physicians to use alternative TKI's that could potentially eradicate leukemic clones carrying a specific ABL KD mutation. Specific ABL KD mutations have been determined to be either sensitive or resistant to imatinib, dasatinib, or ilotinib and therefore treatment modalities can be tailored based on a patient's specific mutation.
This test will detect leukemic clones carrying a BCR-ABL translocation at a level of 1 in 100,000 cells and will identify ABL KD mutations in that population when 20% or more of the cells contain the mutation.
The result is reported as negative or positive with the type of ABL KD mutation detected and whether it is present as a clonal expansion or on a background on non-mutated cells. Results are best interpreted during follow-up monitoring of the BCR-ABL to ABL ratio using the Quantitative BCR-ABL assay.
This test was developed and it's performance characteristics determined by the Clinical Laboratories at the UCSF Medical Center. it has not been cleared or approved by the U.S. Food and Drug Administration.
Administrative
CPT Codes
81170
LDT or Modified FDA
Yes
Complete View
Approval Required
Yes, if not ordered by Adult or Pediatric Hematology-Oncology
Available Stat
No
Test Code
KDSQ
Test Group
BCRABL
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 1x per week as needed, Monday or Wednesday, day shift only
Methodology
RT-PCR and DNA sequencing
Remarks
Due to limited stability samples for this test should not be collected the day before a holiday or 3-day weekend.
Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
Collect
Lavender top
Amount to Collect
Blood: 5 mL
Marrow: 2 mL
Sample Type
EDTA Whole blood or bone marrow
Preferred Volume
Blood: 5 mL
Marrow: 2 mL
Minimum Volume
Blood: 2 mL
Marrow: 1 mL
Unacceptable Conditions
Samples collected in heparin
Specimen Preparation
Do not centrifuge. Refrigerate sample, DO NOT freeze.
Reference Interval
None detected
Synonyms
BCR-ABL mutations
BCR/ABL mutations
CML
Chronic myelogenous leukemia
Gleevec resistance
Iminitab mesylate resistance
Philadelphia chromosome
PH1 chromosome
breakpoint cluster region
Stability (from collection to initiation)
Refrigerated 3 days.
Reported
7-10 days
Reflex Testing
An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.
Additional Information
Treatment of CML and ALL patients positive for BCR-ABL chromosomal translocation is aimed at the eradication of tumor cells carrying the BCR-ABL oncoprotein, which has increased tyrosine kinase activity. Treatment with Gleevec (imatinib mesylate) or other tyrosine kinase inhibitors (TKI's) may result in drug resistance caused by the development of mutations within the ABL kinase domain (KD) of the BCR-ABL oncoprotein. Early identification of these mutations, for example as a patient is monitored for minimal residual disease by PCR, may prevent clinical relapse and allow physicians to use alternative TKI's that could potentially eradicate leukemic clones carrying a specific ABL KD mutation. Specific ABL KD mutations have been determined to be either sensitive or resistant to imatinib, dasatinib, or ilotinib and therefore treatment modalities can be tailored based on a patient's specific mutation.
This test will detect leukemic clones carrying a BCR-ABL translocation at a level of 1 in 100,000 cells and will identify ABL KD mutations in that population when 20% or more of the cells contain the mutation.
The result is reported as negative or positive with the type of ABL KD mutation detected and whether it is present as a clonal expansion or on a background on non-mutated cells. Results are best interpreted during follow-up monitoring of the BCR-ABL to ABL ratio using the Quantitative BCR-ABL assay.
This test was developed and it's performance characteristics determined by the Clinical Laboratories at the UCSF Medical Center. it has not been cleared or approved by the U.S. Food and Drug Administration.
