CAT #: 13090020
BCL2/JH Translocation Assay - Gel Detection
BCL2/JH Translocation Assays are useful for the study of:
- Monitoring and evaluation of follicular lymphomas and other B cell lymphomas
- Distinguishing lymphoma from benign lymphoid hyperplasia
- Distinguishing follicular lymphoma from other B cell lymphomas that may have a similar appearance
- Monitoring and evaluation of disease recurrence
- Detection and assessment of residual disease
- Evaluation of new research and methods in malignancy studies
- Summary of Explanation of the Test
Invivoscribe’s Gene Rearrangement and Translocation Assays represent a new approach to PCR-based clonality testing. These standardized assays were carefully optimized testing positive and negative control samples using multiplex master mixes.
BCL2 translocations are reciprocal chromosome exchanges that place the bcl-2 proto-oncogene, located on chromosome 18, under aberrant transcriptional control of the immunoglobulin heavy chain gene, located on chromosome 14. The bcl-2 protein is an antagonist to apoptosis (programmed cell death), a normal process designed to eliminate unneeded and damaged cells during hematopoiesis. Increased expression of the bcl-2 protein leads to an increase in the levels of B cells in the body. BCL2 t(14;18) translocations are present in 70-90% of follicular non-Hodgkin B cell lymphomas, 50% of undifferentiated B cell lymphomas, and 20-30% of large cell diffuse B cell lymphomas. They are not seen in other lymphomas; therefore, this test is useful for the differential findings of B cell malignancies. Further, presence of the bcl-2 translocation is an indicator of poor prognosis in large cell diffuse B cell lymphomas.
This BCL2 t(14;18) Translocation Assay contains four master mixes. Three of the master mixes target the joining region of the immunoglobulin heavy chain gene, and distinct regions of the BCL2 gene. These master mixes are used to detect major breakpoint region (Mbr) and minor cluster region (mcr) of the BCL2 t(14;18) translocations. The fourth master mix, the Specimen Control Size Ladder, targets multiple genes and generates a series of amplicons of 100, 200, 300, 400, and 600 base pairs to ensure that the quality and quantity of input DNA is adequate to yield a valid result. Positive and negative control DNAs and also included. This assay is used both to identify and monitor BCL2 translocations involving the major breakpoint region (Mbr) and the minor cluster region (mcr). The assay can also be used to detect disease recurrence.
- Specimen Requirements
This assay tests genomic DNA
- 5cc of peripheral blood, bone marrow biopsy, or bone marrow aspirate anti-coagulated with heparin or EDTA. Ship at ambient temperature; OR
- Minimum 5mm cube of tissue shipped frozen; or at room temperature or on ice in RPMI 1640; OR
- 2µg of genomic DNA; OR
- Formalin-fixed paraffin embedded tissue or slides.
Warranty and Liability
Invivoscribe, Inc. (Invivoscribe®) is committed to providing the highest quality products. Invivoscribe® warrants that the products meet or exceed the performance standards described in the Instructions For Use, as to products with such an insert. If a product is covered by product specifications and does not perform as specified, our policy is to replace the product or credit the full purchase price. No other warranties of any kind, expressed or implied, are provided by Invivoscribe®. Invivoscribe® liability shall not exceed the purchase price of the product. Invivoscribe shall have no liability for direct, indirect, consequential or incidental damages arising from the use, results of use, or inability to use its products; product efficacy under purchaser controlled conditions in purchaser’s laboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited to testing of positive, negative, and blank controls every time a sample is tested. Ordering, acceptance, and use of product constitutes purchaser acceptance of sole responsibility for assuring product efficacy and purchaser agreement to the limitation of liability set forth in this paragraph.
This product is for Research Use Only; not for use in diagnostic procedures.
This product is covered by one or more of the following: European Patent Number 1549764, European Patent Number 2418287, European Patent Number 2460889, Japanese Patent Number 4708029, United States Patent 8859748, United States Patent 10280462, and related pending and future applications. All of these patents and applications are licensed exclusively to Invivoscribe®. Additional patents licensed to Invivoscribe covering some of these products apply elsewhere. Many of these products require nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). No license under these patents to use amplification processes or enzymes is conveyed expressly or by implication to the purchaser by the purchase of this product.
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