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EndLymphoma Mutation Assay is a NGS-based mutation profiling assay targeting mutations in 162 genes shown to be mutated in hematologic malignancies, particularly in lymphoid malignancies including 8-cell non-Hodgkin lymphoma (diffuse large 8-cell lymphoma, follicular lymphoma, lymphoplasmacytic lymphoma/Walderstrom macroglobulinemia, marginal zone lymphoma, mantle cell lymphoma), T-cell lymphoma (ALK-negative anaplastic large cell lymphoma, cutaneous T-cell lymphoma, intestinal T-cell lymphoma, peripheral T-cell lymphoma) and plasma cell neoplasms.

Genomic DNA from peripheral blood, bone marrow, Fine Needle aspirate and FFPE is fragmented, end-repaired, and tailed with adenosines to facilitate ligation of unique molecular barcoded adapters to native dsDNA. The molecular-barcoded dsDNA is PCR amplified to build a whole-genome library (WGL) that is hybridized/ captured to cRNA targeting 272 kb genomic loci to enrich for clinically relevant lymphoma biomarkers, and finally batch sequenced within a NextSeq instrument.

Clinical specimens were reviewed for the markers listed in the following table.

10 days for Routine and STAT

• 10¨C30 ml peripheral blood (PB) in purple-top (lavender top) tube (EDTA Vacutainer), sent on wet ice
• 2¨C5 ml of bone marrow aspirate (BM), sent on wet ice
• 2¨C6 ml of Fine Needle Aspirates (FNA) in a sterile 15ml screw cap tube (e.g., lymph node, etc.) containing RPMI and store at 2¨C8¡ãC until delivery to the molecular laboratory
• 5¨C10 unstained paraffin sections and H&E slide with % of tumor and normal areas circled and delivered to the lab with requisition for solid tumor molecular testing
• cDNA, genomic DNA and/or RNA submitted directly for testing is accepted only if extraction or isolation was performed in a CLIA-certified laboratory

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The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.