Interpretation Turn-around Time Specimen Requirements Shipping Conditions Storage Conditions  An interpretive report will be issued indicating whether evidence of clonality was detected. The report further provides a summary of the top 5 merged sequences, including the % total reads, the rearrangement class and the sequence. 5 to 10 business days •  3 mL of peripheral blood in Heparin, EDTA or ACD •  1 mL of bone marrow in Heparin, EDTA or ACD •  500 ng of previously isolated DNA • FFPE tissue samples Ambient or Cool; Do not freeze • Room Temp up to 72 hours •  2-8 °C up to 7 days Test Name IGK clonality assay Assay Type Next-Generation Sequencing (NGS) This test is performed by using the LymphoTrack® Assay from Invivoscribe. Method Description For detection of the vast majority of IGK gene rearrangements, a multiplex master mix targeting the conserved Vƙ, Jƙ, Cƙ ,and kappa deleting element (Kde) regions is used for PCR amplification. Next-generation sequencing of the PCR products is used to identify DNA sequences specific to clonal gene rearrangements. Bioinformatics tools facilitate the characterization of sequences present at greater than 5% of the population. These sequences can be used to track specific clonal populations. Indications for Testing •  Identify clonality in atypical lymphoproliferative disorders •  Support a differential diagnosis between reactive lesions and hematologic malignancies •  Assign presumptive lineage in mature monoclonal lymphoproliferative disorders • Monitor and evaluate disease recurrence Clonaltiy Tests LabPMM Services Catalog 2019 | 35 Clinical Information During development of lymphoid cells, antigen receptor genes undergo somatic gene rearrangements1 . The human immunoglobulin kappa (IGK) locus on chromosome 2 (2p11.2) includes 7 variable (Vƙ) region gene segments and 5 joining (Jƙ) gene segments upstream of the constante (Cƙ) region. The kappa deleting element (Kde), approximately 24 kb downstream of the Jƙ-Cƙ region, can also rearrange with Vƙ gene segments and the isolated recombination signal sequence in the Jƙ-Cƙ intronic region2 . Specifically during B-cell development, genes encoding IGK molecules are assembled from multiple polymorphic gene segments that undergo rearrangements generating gene receptors unique in both length and sequence. Since leukemias and lymphomas originate from the malignant transformation of individual lymphoid cells, which means that all leukemias and lymphomas generally share one or more cell-specific or “clonal” antigen receptor gene rearrangements. Therefore, tests that detect IGK clonal rearrangements can be useful in the study of B- and T-cell malignancies. IGK Clonality Assay References 1.  Tonegawa S (1983) Somatic Generation of Antibody Diversity. Nature 302:575-581. 2. JE Miller et al., Molecular Genetic Pathology (2013, 2nd ed.) Springer Science & Business Media 302.2.7.13 and 30.2.7.18. 34