b'Gel & Capillary | CE-IVD Assays IGL Gene Clonality AssaysGel and CapillaryAssaysIGL Gene Clonality AssaysAssay Description Performance Characteristics The IdentiClone IGL Gene Clonality Assays are in vitro diagnosticData from two independent studies that tested more than 300 products intended for PCR-based detection of clonal immunoglobulinpatient samples of varying types suggests the diagnostic accuracylambda light chain gene rearrangements in patients with suspectof selected IdentiClone tests to be 96%. In both peer-reviewed lymphoproliferations. studies, there were no clear false-positive results generated using the IdentiClone tests, and there was a high level of precision. 2Specifically, the IdentiClone IGL Gene Clonality Assays can be used to: The clinico-histopathological diagnosis correlated well with PCR results in a higher number of patients when compared withIdentify clonality in atypical lymphoproliferative disorders Southern Blot (SB) results, as seen below:PCR/SB concordance: 1Support a differential diagnosis between reactive lesions and hematologic malignancies IGH:93% sensitivity / 92% specificityAssign presumptive lineage in mature monoclonal IGK: 90% sensitivity / 90% specificity lymphoproliferative disorders IGL: 86% sensitivity / 92% specificity Identify tumor-specific markers (IGL gene rearrangements) forTRB: 86% sensitivity / 98% specificity post-treatment monitoring TRG: 89% sensitivity / 94% specificity Monitor and evaluate disease recurrence TRD: 83% sensitivity / 95% specificityPCR vs. SB analysis relative to histopathology and final diagnosis:Summary and Explanation of the Test2PCR/SB concordance:PCR sensitivity: SB sensitivity: The Invivoscribe CE-marked IdentiClone Assays represent a uniqueIGH + IGK: 85% 98% 39% approach to PCR-based clonality testing. These standardizedTRB: 85% 96% 35%assays were carefully optimized testing positive and negative control samples using multiplex master mixes. Assay development was followed by extensive validation including the testing of more thanReference400 clinical samples using Revised European/American Lymphoma1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003). (REAL) Classification. Testing was done at more than thirty prominent independent testing centers throughout Europe in a collaborative study2.Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).known as the BIOMED-2 Concerted Action. Results from this BIOMED-2 study appear in Leukemia, a leading peer-reviewed journal. 1These test kits include twomaster mixes. The IGL Tube master mix targets the variable (V )region and the joining (J )region of the immunoglobulin lambda light chain gene locus (IGL). The Specimen Control Size Ladder targets multiple genes and generates a series of amplicons of approximately 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. A single thermal cycler program and similar detection methodologies are used with all of our gene clonality assays. ThisFigure Legend: Schematic diagram of the immunoglobulin lambda light chain improves consistency and facilitates cross-training. gene complex on chromosome 22q11.2. Shown are the relative positions and orientations for the V and J primers, which are included in the IGL master mix tube. The two V primers only target V1, 2, and 3 because these three V families cover approximately 70% of rearrangeable V gene segments, and approximately 90% of all IGL gene rearrangements involve these three families. Similarly, the single J primer only targets J1, 2, and 3 because these three J segments are involved in 98% of all IGL gene rearrangements.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.64'