b'Gel & Capillary | RUO AssaysGel and CapillaryBCR/ABL t(9;22) Translocation Assays Research Use Only (RUO) AssayBCR/ABL t(9;22) Translocation AssaysAssay Use chromosome 22, with the ABL receptor independent tyrosine kinase gene on chromosome 9. 1,2BCR-ABL1 t(9;22) translocations are present BCR/ABL t(9;22) Translocation Assays are useful for studies involving: in approximately 95% of chronic myeloid leukemia (CML) patients,20-50% of adult acute lymphoblastic leukemia (ALL) patients, anddentification of chronic myeloid leukemia (CML), acute2I 2-10% of pediatric ALL patients.Although cytogenetic detection lymphoblastic leukemia (ALL) of Ph1 is a hallmark of CML, molecular detection of Ph1-positive Monitoring and evaluation of disease recurrence cells by nested reverse transcriptase PCR is faster and significantly Detection and assessment of residual disease more sensitive than cytogenetics or other methods. Nearly 50% of cytogenetically Ph1-negative CML cases are positive by reverse Evaluation of new research and methods in malignancy studies transcriptase PCR analysis. This makes reverse transcriptase PCR detection of Ph1-positive cells of value in predicting early disease recurrence and progression for CML and ALL patients that are in Summary and Explanation of the Testapparent clinical remission following bone marrow transplantation. 3The master mixes are included in these assay kits used to amplifyMolecular detection provides the opportunity for early intervention complementary DNA (cDNA) produced from specimen(s), and positiveand treatment. Thus, molecular testing for chimeric BCR-ABL1 and negative RNA controls (included). Primers target an internaltranscripts is utilized both in diagnostic evaluation and post-control transcript (Abl) and p190-, p210-, and p230-type transcriptstherapeutic monitoring of CMLs and ALLs.expressed from BCR-ABL1 translocations. The limit of detection of this assay is approximately one BCR-ABL1 positive cell in a background of one million normal cells. Amplicon products can be analyzed bySpecimen Requirementscapillary electrophoresis or standard gel electrophoresis with ethidium5 mL of peripheral blood, bone marrow biopsy, or bone marrow bromide staining. A BCR-ABL1 translocation is indicated if just one of the 2nd round master mixes (Mix 2b, Mix 2c, Mix 3b, Mix 3c, or Mixaspirate anticoagulated with heparin or EDTA; or,3d) generates product(s) of the valid size. Reagents for RNA extractionArchived cells frozen in 10% DMSO + 90% Fetal Bovine and reverse transcription are not included. This assay is compatibleSerum (FBS).with all standard RNA extraction and cDNA synthesis methods. This is a qualitative assay and has not been validated for quantitative use. ReferenceBackground1.R Kurzrock et al., Ann. Intern. Med. 138: 819-30 (2003).2. JV Melo. Blood 88: 2375-2384 (1996).The Philadelphia chromosome (Ph1) is a specific chromosomal3. JP Radich et al., Blood 85: 2632-2638 (1995).abnormality that results from reciprocal t(9;22)(q34;q11) chromosome rearrangements that fuse coding regions of the BCR gene, located on Figure Legend: This figure shows the genomic organization of the BCR and ABLBCRgenes on chromosomes 22 and 9, respectively. Boxes represent exon regions ofChromosome 22the ABL (red boxes) and BCR encoding exons (other colors). The solid black line represents intron regions, which have been left incompletely spliced to assist in demarcation of the exon segments. The location of exon regions targeted by labeled and unlabeled primers are indicated by arrows. A p210-type BCR-ABL1ABLtranslocation (b3a2 junction) is depicted in the lower portion of the figure alongChromosome 9with the control ABL transcript control.BCR/ABL t(9;22) Translocationp210 Type, b3a2 junctionABL cDNA Control124'