Run 2x per week, Monday & Wednesday, day shift only
Methodology
Realtime qPCR
Reported
7-14 days
Additional Information
A reciprocal translocation between chromosomes 9 and 22 results in the Philadelphia chromosome, which is commonly associated with chronic myelogenous leukemia (CML) and to a lesser extent with acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML). The oncogenic culprit of the Philadelphia chromosome stems from the fusion of two genes BCR and ABL1, located on chromosomes 22 and 9, respectively. The resulting BCR-ABL1 fusion gene produces an abnormal protein with increased tyrosine kinase activity that activates multiple intracellular signaling pathways, culminating in excessive growth of hematopoietic cells.
Three different variants of the BCR-ABL1 fusion gene correspond to the major, minor and micro breakpoints, which encode respectively for the p210, p190 and p230 proteins, all of which are detected by this assay. The majority of CML patients carry the p210 translocation, whereas the p190 translocation is present in approximately 20% of ALL patients and occasionally in AML. While the p230 translocation has also been detected in classic CML, it has also been found in a subset of patients with chronic neutrophilic leukemia (CNL).
Treatment of patients with CML and ALL is aimed at the eradication of BCR-ABL1 positive tumor cells with tyrosine kinase inhibitors and minimal residual disease monitoring of the therapy effectiveness is achieved by this assay with the quantitative monitoring of BCR-ABL1 mRNA expression.
This realtime qPCR test will detect and quantitate the p210, p190 and p230 BCR-ABL1 translocations. The assay sensitivity is about 1 in 100,000 BCR-ABL1 positive K562 cells and spans 4-5 logs. Results are reported as on the Internal Scale (IS) for p210 (b3a2, b2a2) and as percent ratios for p190 (e1a2) and p230 (e19a2) translocations. Results of minimal residual disease testing are best interpreted in light of previous results obtained from the same laboratory. Inter-laboratory comparison of IS ratios remains variable.
This test was developed and its performance characteristics determined by the Clinical Laboratories at the Medical Center at UC San Francisco. 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
CML
Chronic mylogenous leukemia
Philadelphia chromosome
Breakpoint cluster region
Translocation 9:22
t(9:22)
ALL
Realtime-qPCR
Ph+ Acute Lymphoblastic Leukemia
p210
p190
p230
Sample Type
EDTA whole blood, Marrow
Collect
Lavender top
Amount to Collect
Blood: 5 mL
Bone marrow aspirate: 2 mL
Preferred Volume
Blood: 5 mL
Bone marrow aspirate: 2 mL
Minimum Volume
Blood: 2 mL
Bone marrow aspirate: 2 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
Heparinized samples
Frozen samples
Test Code
BCRABL
Test Group
BCRABL
Performing Lab
Medical Genomics - Molecular Diagnostics
Specimen Preparation
Do not centrifuge. Refrigerate sample, DO NOT freeze.
Preferred Volume
Blood: 5 mL
Bone marrow aspirate: 2 mL
Minimum Volume
Blood: 2 mL
Bone marrow aspirate: 2 mL
Unacceptable Conditions
Heparinized samples
Frozen samples
Stability (from collection to initiation)
Refrigerated 3 days.
Units
% IS bcr:abl/abl ratio
Reference Interval
No bcr:abl transcripts detected
Additional Information
A reciprocal translocation between chromosomes 9 and 22 results in the Philadelphia chromosome, which is commonly associated with chronic myelogenous leukemia (CML) and to a lesser extent with acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML). The oncogenic culprit of the Philadelphia chromosome stems from the fusion of two genes BCR and ABL1, located on chromosomes 22 and 9, respectively. The resulting BCR-ABL1 fusion gene produces an abnormal protein with increased tyrosine kinase activity that activates multiple intracellular signaling pathways, culminating in excessive growth of hematopoietic cells.
Three different variants of the BCR-ABL1 fusion gene correspond to the major, minor and micro breakpoints, which encode respectively for the p210, p190 and p230 proteins, all of which are detected by this assay. The majority of CML patients carry the p210 translocation, whereas the p190 translocation is present in approximately 20% of ALL patients and occasionally in AML. While the p230 translocation has also been detected in classic CML, it has also been found in a subset of patients with chronic neutrophilic leukemia (CNL).
Treatment of patients with CML and ALL is aimed at the eradication of BCR-ABL1 positive tumor cells with tyrosine kinase inhibitors and minimal residual disease monitoring of the therapy effectiveness is achieved by this assay with the quantitative monitoring of BCR-ABL1 mRNA expression.
This realtime qPCR test will detect and quantitate the p210, p190 and p230 BCR-ABL1 translocations. The assay sensitivity is about 1 in 100,000 BCR-ABL1 positive K562 cells and spans 4-5 logs. Results are reported as on the Internal Scale (IS) for p210 (b3a2, b2a2) and as percent ratios for p190 (e1a2) and p230 (e19a2) translocations. Results of minimal residual disease testing are best interpreted in light of previous results obtained from the same laboratory. Inter-laboratory comparison of IS ratios remains variable.
This test was developed and its performance characteristics determined by the Clinical Laboratories at the Medical Center at UC San Francisco. It has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Codes
81206, 81207, 81208
LDT or Modified FDA
Yes
LOINC Codes
46434-7
Available Stat
No
Test Code
BCRABL
Test Group
BCRABL
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 2x per week, Monday & Wednesday, day shift only
Methodology
Realtime qPCR
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
Bone marrow aspirate: 2 mL
Sample Type
EDTA whole blood, Marrow
Preferred Volume
Blood: 5 mL
Bone marrow aspirate: 2 mL
Minimum Volume
Blood: 2 mL
Bone marrow aspirate: 2 mL
Unacceptable Conditions
Heparinized samples
Frozen samples
Specimen Preparation
Do not centrifuge. Refrigerate sample, DO NOT freeze.
Units
% IS bcr:abl/abl ratio
Reference Interval
No bcr:abl transcripts detected
Synonyms
CML
Chronic mylogenous leukemia
Philadelphia chromosome
Breakpoint cluster region
Translocation 9:22
t(9:22)
ALL
Realtime-qPCR
Ph+ Acute Lymphoblastic Leukemia
p210
p190
p230
Stability (from collection to initiation)
Refrigerated 3 days.
Reported
7-14 days
Reflex Testing
An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.
Additional Information
A reciprocal translocation between chromosomes 9 and 22 results in the Philadelphia chromosome, which is commonly associated with chronic myelogenous leukemia (CML) and to a lesser extent with acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML). The oncogenic culprit of the Philadelphia chromosome stems from the fusion of two genes BCR and ABL1, located on chromosomes 22 and 9, respectively. The resulting BCR-ABL1 fusion gene produces an abnormal protein with increased tyrosine kinase activity that activates multiple intracellular signaling pathways, culminating in excessive growth of hematopoietic cells.
Three different variants of the BCR-ABL1 fusion gene correspond to the major, minor and micro breakpoints, which encode respectively for the p210, p190 and p230 proteins, all of which are detected by this assay. The majority of CML patients carry the p210 translocation, whereas the p190 translocation is present in approximately 20% of ALL patients and occasionally in AML. While the p230 translocation has also been detected in classic CML, it has also been found in a subset of patients with chronic neutrophilic leukemia (CNL).
Treatment of patients with CML and ALL is aimed at the eradication of BCR-ABL1 positive tumor cells with tyrosine kinase inhibitors and minimal residual disease monitoring of the therapy effectiveness is achieved by this assay with the quantitative monitoring of BCR-ABL1 mRNA expression.
This realtime qPCR test will detect and quantitate the p210, p190 and p230 BCR-ABL1 translocations. The assay sensitivity is about 1 in 100,000 BCR-ABL1 positive K562 cells and spans 4-5 logs. Results are reported as on the Internal Scale (IS) for p210 (b3a2, b2a2) and as percent ratios for p190 (e1a2) and p230 (e19a2) translocations. Results of minimal residual disease testing are best interpreted in light of previous results obtained from the same laboratory. Inter-laboratory comparison of IS ratios remains variable.
This test was developed and its performance characteristics determined by the Clinical Laboratories at the Medical Center at UC San Francisco. It has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Codes
81206, 81207, 81208
LDT or Modified FDA
Yes
LOINC Codes
46434-7
Ordering
Available Stat
No
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 2x per week, Monday & Wednesday, day shift only
Methodology
Realtime qPCR
Reported
7-14 days
Additional Information
A reciprocal translocation between chromosomes 9 and 22 results in the Philadelphia chromosome, which is commonly associated with chronic myelogenous leukemia (CML) and to a lesser extent with acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML). The oncogenic culprit of the Philadelphia chromosome stems from the fusion of two genes BCR and ABL1, located on chromosomes 22 and 9, respectively. The resulting BCR-ABL1 fusion gene produces an abnormal protein with increased tyrosine kinase activity that activates multiple intracellular signaling pathways, culminating in excessive growth of hematopoietic cells.
Three different variants of the BCR-ABL1 fusion gene correspond to the major, minor and micro breakpoints, which encode respectively for the p210, p190 and p230 proteins, all of which are detected by this assay. The majority of CML patients carry the p210 translocation, whereas the p190 translocation is present in approximately 20% of ALL patients and occasionally in AML. While the p230 translocation has also been detected in classic CML, it has also been found in a subset of patients with chronic neutrophilic leukemia (CNL).
Treatment of patients with CML and ALL is aimed at the eradication of BCR-ABL1 positive tumor cells with tyrosine kinase inhibitors and minimal residual disease monitoring of the therapy effectiveness is achieved by this assay with the quantitative monitoring of BCR-ABL1 mRNA expression.
This realtime qPCR test will detect and quantitate the p210, p190 and p230 BCR-ABL1 translocations. The assay sensitivity is about 1 in 100,000 BCR-ABL1 positive K562 cells and spans 4-5 logs. Results are reported as on the Internal Scale (IS) for p210 (b3a2, b2a2) and as percent ratios for p190 (e1a2) and p230 (e19a2) translocations. Results of minimal residual disease testing are best interpreted in light of previous results obtained from the same laboratory. Inter-laboratory comparison of IS ratios remains variable.
This test was developed and its performance characteristics determined by the Clinical Laboratories at the Medical Center at UC San Francisco. 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
CML
Chronic mylogenous leukemia
Philadelphia chromosome
Breakpoint cluster region
Translocation 9:22
t(9:22)
ALL
Realtime-qPCR
Ph+ Acute Lymphoblastic Leukemia
p210
p190
p230
Collection
Sample Type
EDTA whole blood, Marrow
Collect
Lavender top
Amount to Collect
Blood: 5 mL
Bone marrow aspirate: 2 mL
Preferred Volume
Blood: 5 mL
Bone marrow aspirate: 2 mL
Minimum Volume
Blood: 2 mL
Bone marrow aspirate: 2 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
Heparinized samples
Frozen samples
Processing
Test Code
BCRABL
Test Group
BCRABL
Performing Lab
Medical Genomics - Molecular Diagnostics
Specimen Preparation
Do not centrifuge. Refrigerate sample, DO NOT freeze.
Preferred Volume
Blood: 5 mL
Bone marrow aspirate: 2 mL
Minimum Volume
Blood: 2 mL
Bone marrow aspirate: 2 mL
Unacceptable Conditions
Heparinized samples
Frozen samples
Stability (from collection to initiation)
Refrigerated 3 days.
Result Interpretation
Units
% IS bcr:abl/abl ratio
Reference Interval
No bcr:abl transcripts detected
Additional Information
A reciprocal translocation between chromosomes 9 and 22 results in the Philadelphia chromosome, which is commonly associated with chronic myelogenous leukemia (CML) and to a lesser extent with acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML). The oncogenic culprit of the Philadelphia chromosome stems from the fusion of two genes BCR and ABL1, located on chromosomes 22 and 9, respectively. The resulting BCR-ABL1 fusion gene produces an abnormal protein with increased tyrosine kinase activity that activates multiple intracellular signaling pathways, culminating in excessive growth of hematopoietic cells.
Three different variants of the BCR-ABL1 fusion gene correspond to the major, minor and micro breakpoints, which encode respectively for the p210, p190 and p230 proteins, all of which are detected by this assay. The majority of CML patients carry the p210 translocation, whereas the p190 translocation is present in approximately 20% of ALL patients and occasionally in AML. While the p230 translocation has also been detected in classic CML, it has also been found in a subset of patients with chronic neutrophilic leukemia (CNL).
Treatment of patients with CML and ALL is aimed at the eradication of BCR-ABL1 positive tumor cells with tyrosine kinase inhibitors and minimal residual disease monitoring of the therapy effectiveness is achieved by this assay with the quantitative monitoring of BCR-ABL1 mRNA expression.
This realtime qPCR test will detect and quantitate the p210, p190 and p230 BCR-ABL1 translocations. The assay sensitivity is about 1 in 100,000 BCR-ABL1 positive K562 cells and spans 4-5 logs. Results are reported as on the Internal Scale (IS) for p210 (b3a2, b2a2) and as percent ratios for p190 (e1a2) and p230 (e19a2) translocations. Results of minimal residual disease testing are best interpreted in light of previous results obtained from the same laboratory. Inter-laboratory comparison of IS ratios remains variable.
This test was developed and its performance characteristics determined by the Clinical Laboratories at the Medical Center at UC San Francisco. It has not been cleared or approved by the U.S. Food and Drug Administration.
Administrative
CPT Codes
81206, 81207, 81208
LDT or Modified FDA
Yes
LOINC Codes
46434-7
Complete View
Available Stat
No
Test Code
BCRABL
Test Group
BCRABL
Performing Lab
Medical Genomics - Molecular Diagnostics
Performed
Run 2x per week, Monday & Wednesday, day shift only
Methodology
Realtime qPCR
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
Bone marrow aspirate: 2 mL
Sample Type
EDTA whole blood, Marrow
Preferred Volume
Blood: 5 mL
Bone marrow aspirate: 2 mL
Minimum Volume
Blood: 2 mL
Bone marrow aspirate: 2 mL
Unacceptable Conditions
Heparinized samples
Frozen samples
Specimen Preparation
Do not centrifuge. Refrigerate sample, DO NOT freeze.
Units
% IS bcr:abl/abl ratio
Reference Interval
No bcr:abl transcripts detected
Synonyms
CML
Chronic mylogenous leukemia
Philadelphia chromosome
Breakpoint cluster region
Translocation 9:22
t(9:22)
ALL
Realtime-qPCR
Ph+ Acute Lymphoblastic Leukemia
p210
p190
p230
Stability (from collection to initiation)
Refrigerated 3 days.
Reported
7-14 days
Reflex Testing
An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.
Additional Information
A reciprocal translocation between chromosomes 9 and 22 results in the Philadelphia chromosome, which is commonly associated with chronic myelogenous leukemia (CML) and to a lesser extent with acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML). The oncogenic culprit of the Philadelphia chromosome stems from the fusion of two genes BCR and ABL1, located on chromosomes 22 and 9, respectively. The resulting BCR-ABL1 fusion gene produces an abnormal protein with increased tyrosine kinase activity that activates multiple intracellular signaling pathways, culminating in excessive growth of hematopoietic cells.
Three different variants of the BCR-ABL1 fusion gene correspond to the major, minor and micro breakpoints, which encode respectively for the p210, p190 and p230 proteins, all of which are detected by this assay. The majority of CML patients carry the p210 translocation, whereas the p190 translocation is present in approximately 20% of ALL patients and occasionally in AML. While the p230 translocation has also been detected in classic CML, it has also been found in a subset of patients with chronic neutrophilic leukemia (CNL).
Treatment of patients with CML and ALL is aimed at the eradication of BCR-ABL1 positive tumor cells with tyrosine kinase inhibitors and minimal residual disease monitoring of the therapy effectiveness is achieved by this assay with the quantitative monitoring of BCR-ABL1 mRNA expression.
This realtime qPCR test will detect and quantitate the p210, p190 and p230 BCR-ABL1 translocations. The assay sensitivity is about 1 in 100,000 BCR-ABL1 positive K562 cells and spans 4-5 logs. Results are reported as on the Internal Scale (IS) for p210 (b3a2, b2a2) and as percent ratios for p190 (e1a2) and p230 (e19a2) translocations. Results of minimal residual disease testing are best interpreted in light of previous results obtained from the same laboratory. Inter-laboratory comparison of IS ratios remains variable.
This test was developed and its performance characteristics determined by the Clinical Laboratories at the Medical Center at UC San Francisco. It has not been cleared or approved by the U.S. Food and Drug Administration.
