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BCR/ABL Quantitative by PCR
|Utilization Guidelines||Tests with long turn-around times (ie. Molecular based tests and Microarrays) should only be requested on an inpatient if the result is going to affect the inpatient management.
If the patient will likely be discharged before the result will be available, the test should be requested after discharge. (NOTE: UCSF Medical Center is not reimbursed for inpatient testing).
An exception to the above may be appropriate if there is a possibility the patient will not survive to be discharged and the information is important for diagnosis and/or family decisions/management (ie. recurrence risk).
|Performed by||Medical Genomics - Molecular Diagnostics|
|In House Availability||Run 2x per week, Monday & Wednesday, day shift only|
|Collection Instructions||Do not collect sample in heparin. Keep sample refrigerated for overnight or longer storage.
For UCSF Samples (from remote sites) Click here for sample collection instructions
For NON-UCSF Samples Click here for Requisition form & Account set-up instructions. Note we only do institutional billing.
|Container type||Lavender top|
|Amount to Collect||5 mL blood|
|Sample type||EDTA whole blood, Marrow|
|UCSF Rejection Criteria||Heparinized samples|
|Processing notes||Do not centrifuge. Refrigerate sample, DO NOT freeze.|
|Units||Ratio bcr:abl/abl (%)|
|Normal range||No bcr:abl transcripts (0%)|
|Synonyms||PCR; CML; Chronic mylogenous leukemia; Philadelphia chromosome; PH1 chromosome; Breakpoint cluster region; Tyrosine kinase; Translocation 9:22; t(9:22); Ph' chromosome; Philadelphia chromosome; ALL; PH1 chromosome|
|Stability||Refrigerated 3 days.|
|Turn around times||7-10 days|
|Additional information||An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.
Translocation between chromosomes 9 and 22 results in the Philadelphia chromosome, which causes several types of leukemia. The oncogenic culprit of the Philadelphia chromosome stems from the fusion of two genes abl and bcr, normally located on chromosomes 9 and 22, respectively. The resulting bcr-abl fusion gene produces an abnormal protein with increased tyrosine kinase activity that activates multiple intracellular signaling pathways culminating in excessive growth of hematopoeitic cells.
Two variants of the bcr-abl fusion gene result in proteins of 210 kDa and 190 kDa, termed respectively p210 and p190. Virtually all patients with chronic myelogenous leukemia (CML) have the p210 translocation, whereas the p190 is present in approximately 20% of patients with acute lymphoblastic leukemia (ALL).
Treatment of patients with CML and ALL is aimed at the eradication of tumor cells with the bcr-abl translocation. Detection of the bcr-abl translocation is performed for the initial diagnosis of CML/ALL and for monitoring its expression levels in patients treated with Gleevec or other drugs.
This PCR based test will detect and quantitate the p210 and the p190 bcr-abl translocations in 1 in 100,000 K562 cells. The result of this highly sensitive test is expressed as a percent ratio of bcr-abl to abl cells. Results of minimal residual disease are best interpreted in light of previous results obtained from the same testing laboratory only. Inter-laboratory comparison of percent ratios is not reliable and uninformative.
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 coding||81206, 81207|
|LDT or Mod FDA?||Yes|
|Last Updated||1/22/2014 8:59:39 AM|