b'MRD TestsTest Name region is used for PCR amplification. Next-generation IGH FR1 MRD Clonality Assaysequencing of the PCR products is used to identify IGH FR2 MRD Clonality AssayDNA sequences specific to previously identified clonal IGH FR3 MRD Clonality Assayrearrangements detected at diagnosis. Bioinformaticstools facilitate the detection of these specific sequences IGHV Leader MRD Somatic Hypermutation Clonality Assay present at MRD levels up to 1 x 10 -6with sufficient DNA input. Assay Type The assay typically requires a sample taken at diagnosis as well as the post-treatment follow-up samples. If the patient Next-Generation Sequencing (NGS)has previously been tested by LabPMM for IGH clonality,For Research Use Only no diagnostic sample is needed. This test is performed by using the LymphoTrack Assay from Invivoscribe. Data is analyzed using the LymphoTrackIndications for TestingMRD Software (RUO). Identify tumor-specific markers for post-treatment monitoring Method Description Monitor and evaluate disease recurrenceTo track and identify previously detected IGH clonal sequences in post-treatment follow-up samples, a multiplex master mix targeting the conserved framework region 1, framework region 2, or framework region 3, and the joining Interpretation TurnaroundSpecimenShippingSpecimen Time Requirements Conditions StabilityAn interpretive5 to 14 1-3 mL of peripheral Ambient or Cool; 2-8 C up report will bebusiness daysblood in EDTA do not freezeto 7 days priorissued indicating0.25-1 mL of bone marrow (peripheral blood orto testingwhether IGH MRDbone marrow) was detected in EDTAAmbient or frozen on 700-3500 ng of previously isolated DNA dependingdry ice (isolated DNA) on level of sensitivity requiredLabPMM Services Catalog 2021|41'