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BCR-ABL1 P210 IVD Quantitative qPCR Test


To inform all physicians and clinics that UCI Health’s Department of Pathology and Laboratory Medicine will begin implementing a new FDA-cleared quantitative assay for monitoring BCR-ABL Major (p210) transcript levels. This test will replace our current quantitative BCR-ABL assay. The BCR-ABL1 translocation [t(9;22)(q34;q11)] is present in chronic myelogenous leukemia (CML), 20-30% of adult acute lymphoblastic leukemia (ALL) and a subset of pediatric (ALL). The vast majority of BCR and ABL1 gene rearrangements in CML results in either the e13a2 or e14a2 fusion transcript that gives rise to the p210 fusion protein. Molecular assessment of BCR-ABL1 transcript levels has become the standard of care in monitoring CML and translocation positive ALL patients undergoing Tyrosine Kinase Inhibitor (TKI) therapy.


This assay is FDA approved and is designed to quantitatively measure e13a2 and/or e14a2 fusion transcripts (p210 fusion protein) in total RNA from whole blood. Please note that this assay is not FDA approved for bone marrow samples, and it will not detect the e1a2 fusion transcript that encodes the p190 fusion protein. For p190 testing, please order “BCR-ABL1 Minor Breakpoint Quantitative Test (BCRMIN).” To determine the type of BCR-ABL1 translocation (p210 vs. p190), please order BCR-ABL Qualitative Test (BAQUAL). Expression levels for p210 fusion transcript are reported directly on the International Scale (IS) but will not include copy numbers in the reports. The reportable range of this test is 50%IS/MR0.3 at the upper limit, and 0.002% IS/MR4.7 (4.7 log molecular reduction from 100% IS) at the lower limit of detection.



Specimen: Two (2) 4.0 mL whole blood in EDTA (lavender) top tubes or
one (1) 10 mL whole blood in K2 EDTA (lavender) top tube.
Bone marrow is NOT acceptable. Collect separate tube(s) dedicated for use on this test only.

Test Methodology: Real time quantitative PCR

Test Code: BCR210

Turnaround Time (TAT):
Routine: 5 - 7 days
Set-up days: 1 to 2 times a week depending on the number of samples batched

Ambient: Up to 2 hours from collection time
Refrigerated: 24 - 72 hours (must be received by Molecular Pathology lab within 72 hours of collection)
Frozen: Unacceptable

Rejection Criteria: Bone marrow specimens, gross hemolysis and incorrect collection tubes

A summary of all tests offered by our Laboratory Services can be found here:


Jeff Chan, MD, PhD
Director, Diagnostic Molecular Pathology Laboratory

Edwin S. Monuki, MD, PhD
Chair, Department of Pathology & Laboratory Medicine