b'Minimal Residual Disease TestsMinimal Residual Diseases (MRD) testing has showndesign-controlled bioinformatics software. Due to the strong potential for the optimization of therapeuticread depth of this non-biased patient agnostic testing management of lymphoproliferative diseases. Currently,approach, ultra deep sequencing overcomes virtually all MRD tests complement and leverage the informationof the shortcomings of other MRD technologies, providing obtained at diagnosis. Due to their increased sensitivity,internationally harmonized MRD testing for virtually any these measurements are most useful at time points wheretargeted biomarker.they are compared and contrasted with more traditional methods. An example of this is before transplant, whenLabPMMs MRD tests are NGS-based assays that can be MRD levels have been shown to be predictive used to detect clonal gene rearrangements identified at of transplantation success. diagnosis within virtually all of the antigen receptor loci (B- and T-cells). Once a specific rearrangement sequence Several patient-specific PCR-based (e.g. ASO-PCR) and(the clonotype) has been identified in a primary sample, flow cytometric technologies have been developed bybioinformatics tools allow for easy tracking of clonal regional test centers in order to routinely assess MRDpopulations at greater sensitivity, provided sufficient DNA levels during the course of therapy. However, ASO-PCRis tested. Sensitivity (limit of detection) is determined by the requires patient- and tumor-specific primer and probenumber of cell equivalents of DNA that are interrogated sets, making it cost prohibitive and impossible to offerand the number of sequencing reads generated per as a standardized method. Flow cytometryeven moresample. sensitive multiparameter flow cytometry protocolsare difficult to standardize between testing centers. Both ofLabPMM also offers FLT3 ITD and NPM1 MRD assays, these methods do not generate results that meet thewhich are used for the detection of targeted mutations.internationally recognized criteria for harmonization for These sensitive NGS-enabled assays reliably detect a quantitative measure of residual disease, and neithersequences present at 5 x 10 -5 .meet the standards required to take them through the regulatory agencies. Next-Generation Sequencing (NGS) methods have recently been developed for the detection and monitoring of MRD. These forefront technologies use regulatory-compliant chemistries, run on regulatory-compliant instruments, and can be interpreted using regulatory compliant, and 36 LabPMM Services Catalog 2020|37'