Test Id : P210M
BCR::ABL1, p210, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Chronic Myeloid Leukemia (CML), Bone Marrow
Useful For
Suggests clinical disorders or settings where the test may be helpful
Monitoring response to therapy in patients with chronic myeloid leukemia who are known to have the e13a2 or e14a2 BCR::ABL1 fusion transcript forms
Method Name
A short description of the method used to perform the test
Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Acute lymphoblastic leukemia (ALL)
Acute myeloid leukemia (AML)
B lymphoblastic leukemia (B-ALL)
BCR ABL
BCR-ABL1
BCR/ABL
Chronic myelogenous leukemia (CML)
Philadelphia chromosome, Ph bone marrow/blood
T lymphoblastic leukemia (T-ALL)
t(9;22)
Tyrosine kinase inhibitor (TKI) therapy monitoring, PCR
Specimen Type
Describes the specimen type validated for testing
Bone Marrow
Ordering Guidance
This test detects only the e13a2 and e14a2 fusion forms, which code for the p210 protein. Other fusion forms are not detected, including those containing the BCR e1 exon, which codes for the p190 protein commonly found in acute lymphoblastic leukemia (ALL). If the patient is known to carry an e1a2 (p190) fusion form, the test that should be used for monitoring is BA190 / BCR/ABL, p190, mRNA Detection, Reverse Transcription-PCR (RT-PCR), Quantitative, Monitoring Assay, Varies.
This test should not be used to screen for BCR::ABL1 fusions at the time of diagnosis. If a diagnostic screen for BCR::ABL1 transcripts is desired, order BADX / BCR/ABL1, Qualitative, Diagnostic Assay, Varies, which is designed to detect all reported common and rare BCR::ABL1 mRNA fusion variants.
Shipping Instructions
Specimen must arrive within 72 hours of collection. Collect and package specimen as close to shipping time as possible. Specimens greater than 3 days old at the time of receipt will be considered unacceptable.
Necessary Information
The following information is required:
1. Pertinent clinical history including if the patient has a diagnosis of chronic myeloid leukemia or other BCR::ABL1-positive neoplasm
2. Date of collection
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Container/Tube:
Preferred: Lavender top (EDTA)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix bone marrow.
2. Send specimen in original tube. Do not aliquot.
3. Label specimen as bone marrow
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
1 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Bone Marrow | Refrigerated (preferred) | 72 hours | PURPLE TOP/EDTA |
| Ambient | 72 hours | PURPLE TOP/EDTA |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Monitoring response to therapy in patients with chronic myeloid leukemia who are known to have the e13a2 or e14a2 BCR::ABL1 fusion transcript forms
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Chronic myeloid leukemia (CML) is a hematopoietic stem cell neoplasm included in the broader diagnostic category of myeloproliferative neoplasms. CML is consistently associated with fusion of the breakpoint cluster region gene (BCR) at chromosome 22q11 to the Abelson gene (ABL1) at chromosome 9q23. This fusion is designated BCR::ABL1 and may be seen on routine karyotype as the Philadelphia chromosome.
Although various breakpoints within the BCR and ABL1 genes have been described, more than 95% of CML cases contain a consistent messenger RNA (mRNA) transcript in which either the BCR exon 13 (e13) or BCR exon 14 (e14) is fused to the ABL1 exon 2 (a2), yielding fusion forms e13a2 and e14a2, respectively. The e13a2 and e14a2 fusion forms produce a 210-kDa protein (p210). The p210 fusion protein is an abnormal tyrosine kinase known to be critical for the clinical and pathologic features of CML, and agents that block the tyrosine kinase activity (ie, tyrosine kinase inhibitors [TKI], such as imatinib mesylate) have been used successfully for treatment. Monitoring the level of BCR::ABL1 mRNA in patients with CML during their treatment is helpful for both prognosis and management of therapy.(1-3) Rising BCR::ABL1 mRNA levels following attainment of critical therapeutic milestones can be indicative of acquired resistance variants involving the ABL1 portion of the BCR::ABL1 fusion gene.
Quantitative reverse-transcription polymerase chain reaction is the most sensitive method for monitoring BCR::ABL1 levels during treatment. This test detects the BCR::ABL1 mRNA fusion forms found in CML (e13a2 and e14a2).
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
An interpretive report will be provided.
Interpretation
Provides information to assist in interpretation of the test results
When BCR::ABL1 messenger RNA (mRNA) is present, quantitative results are reported on the international scale (IS), established from data originally reported in the IRIS (International Randomized Study of Interferon versus STI571) trial involving newly diagnosed chronic myeloid leukemia patients. Using the IS, a result of less than 0.1% BCR::ABL1 (p210):ABL1 is equivalent to a major molecular response. This value is also designated on a log scale (molecular response [MR]) as MR3. For additional discussion of the international scale, see Clinical References.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The precision of this assay at low BCR::ABL1 levels is more variable, such that interassay variation can be as high as + or - 0.5 log. Only level changes above 0.5 log should be considered clinically significant. For example, if a result is given as 0.1% BCR::ABL1:ABL1, then any result between 0.05% and 0.5% should be considered essentially equivalent. If the results are being used to make major therapeutic decisions, significant changes during monitoring should be verified with a subsequent specimen.
In general, the results of this assay cannot be directly compared with results generated from other polymerase chain reaction (PCR) assays, including identical assays performed in other laboratories. Monitoring should be performed using the same method and laboratory for each subsequent specimen.
The results of this assay cannot be directly compared with BCR::ABL1 results obtained using fluorescence in situ hybridization (FISH) technology. FISH measures DNA alleles and reverse transcription PCR-based assays measure messenger RNA (mRNA) transcripts. Because a single fusion DNA allele can produce many mRNA transcripts, the values are not directly comparable, and FISH results are not applicable to the international scale or to disease monitoring.
Blood is the specimen of choice for monitoring patients with chronic myeloid leukemia (CML). The majority of patients with CML show similar BCR::ABL1 mRNA levels in blood and bone marrow collected at the same time. Although occasionally, patients may exhibit a difference in concurrent blood and marrow levels for technical or biological reasons, requiring follow-up testing to resolve.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Hughes TP, Kaeda J, Branford S, et al. Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia. N Engl J Med. 2003;349(15):1423-1432
2. Baccarini M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013;122(6):872-884. doi:10.1182/blood-2013-05-501569
3. Press RD, Kamel-Reid S, Ang D. BCR-ABL1 RT-qPCR for monitoring the molecular response to tyrosine kinase inhibitors in chronic myeloid leukemia. J Mol Diagn. 2013;15(5):565-576. doi:10.1016/j.jmoldx.2013.04.007
4. Cross NC, White HE, Muller MC, Saglio G, Hochhaus A. Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia. 2012;26(10):2172-2175. doi:10.1038/leu.2012.104
5. National Comprehensive Cancer Network Practice Guidelines in Oncology: Chronic Myeloid Leukemia 2015. Accessed July 18, 2025. Available at https://www.nccn.org
Method Description
Describes how the test is performed and provides a method-specific reference
The assay is performed using an automated platform, GeneXpert (Cepheid). Bone marrow is processed, added to an individual sample cartridge, and loaded onto the GeneXpert machine. All subsequent reactions are performed within the cartridge and the results are processed and calculated by the instrument. Within the cartridge, RNA is extracted and converted to complementary DNA (cDNA). Quantitative, reverse transcription polymerase chain reaction (PCR) is performed with a nested PCR reaction containing primers designed to amplify cDNA from the e13a2 and e14a2 BCR::ABL1 fusion products. A fragment of ABL1 cDNA is also amplified as a control for RNA degradation and for normalization of BCR::ABL1 results. The ratio of BCR::ABL1 (p210) to ABL1 is calculated from the difference in the crossing thresholds of BCR::ABL1 (p210) and ABL1 products in relation to a lot-specific standard curve, referenced to the international scale (IS). Lot-to-lot variation in the cartridges is corrected using a calibration calculation to reference standard curve data to the IS provided by the manufacturer.(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
81206-BCR/ABL1 (t[9;22]) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, qualitative or quantitative
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| P210M | BCR/ABL1 p210, Quant, Monitor, BM | 55135-8 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| 623207 | Indication for Testing | 42349-1 |
| 623208 | Specimen | 31208-2 |
| 623278 | Source | 31208-2 |
| 623209 | Sample ID | 80398-1 |
| 623210 | Result | 82939-0 |
| 621762 | Interpretation | 59465-5 |
| 623211 | Method Summary | 85069-3 |
| 623212 | Disclaimer | 62364-5 |
| 621763 | Signing Pathologist | 19139-5 |