Test Name MyAML - NGS gene panel assay Assay Type Next-Generation Sequencing (NGS) CLIA validated assay Method Description Using proprietary design, the coding regions and potential genomic breakpoints within known somatic gene fusions are sequenced to an average depth of coverage of 1000x. By utilizing long read lengths, the assay accurately detects and characterizes the breakpoints of structural variants and gene fusions, often with single base pair precision. In addition, these long reads enhance the ability to identify both the insertion site and DNA content of large internal tandem duplications. Coupling comprehensive gene coverage with enhanced depth of coverage, long read lengths, and the power of our robust annotation software and bioinformatics database, MyAML identifies the underlying somatic mutations that are present in as low as 5% allelic frequency. The data and report include single base resolution of the genomic breakpoint and sequences of mutations, facilitating both minimal residual disease testing and temporal and longitudinal studies. A completed patient consent form must be submitted for each sample sent to LabPMM. Indications for Testing • At initial diagnosis of AML • Stratifying risk for AML • Recurrence of leukemia Interpretation Turn-around Time Specimen Requirements Shipping Conditions Storage Conditions An interpretive report will be issued indicating the SNVs, indels, inversions and translocations identified 7 to 14 business days •  3 mL of peripheral blood in Heparin, EDTA or ACD •  1 mL of bone marrow in Heparin, EDTA or ACD •  Cell Pellets in cell culture media or buffered solutions without fixatives •  1 µg of purified, high quality genomic DNA Ambient or Cool; Do not freeze • Room Temp up to 72 hours •  2-8 °C up to 7 days NGS Cancer Panels LabPMM Services Catalog 2019 | 57 Clinical Information Understanding clonal architecture of AML patients is vital for successful treatments1 . Many different mutations, epigenetic aberrations, or downstream abnormalities can likely generate the same clinical picture. However, these differences are responsible for the variable responses observed with therapy, which is a major feature in patients with AML2 . Therefore, since varied somatic mutations affect patient outcomes, conventional genotyping is no longer the most suitable method for screening patients. The MyAML is a CLIA validated assay that identifies clinically actionable, pathogenic, and potentially pathogenic mutations in 194 genes associated with AML. Using the latest version in Next-Generation Sequencing chemistry, MyAML identifies all somatic mutations, large and small insertions/deletion, and translocations under NCCN/ELN guidelines, as well as novel somatic variants that may have prognostic significance for AML. Screening with MyAML allows for treatment decisions to be made once all the relevant mutations are known, both in the prevalent clones, as well as the 'secondary' or 'tertiary' clones, which could become the new prominent clones leading to remission. MyAML® References 1.  Döhner K et al. (2014) Intermediate-risk acute myeloid leukemia therapy: current and future. Hematology Am Soc Hematol Educ Program 1,34-43. 2.  Estey EH (2014) Acute myeloid leukemia: 2014 update on risk-stratification and management. Am J Hematol 89:1063-1081. List of Genes on the MyAML Panel Structural Rearrangements Inv(16) t(16;16) t(8;21) t(15;17) +8 t(9;11) -5 5q- -7 7q- 11q23 inv(3) t(3;3) t(6;9) t(9;22) Genes CEBPA DNMT3A FLT3 IDH1 IDH2 KIT NPM1 Other Fusions and Gene Rearrangements ABL1 ADGRG7 AFF1 BCR CBFB CREBBP DEK EIF4E2 ELL ETV6 GAS6 GAS7 KAT6A KAT6B KMT2A MECOM MKL1 MLLT10 MLLT1 MLLT3 MLLT4 MYH11 NSD1 NUP214 NUP98 PICALM PML RARA RBM15 RPN1 RUNX1 RUNX1T1 SEPT5 SET TFG TMEM255B Other Genes ABCC1 ACVR2B ADRBK1 AKAP13 ANKRD24 ARID2 ARID4B ASXL1 ASXL2 ASXL3 BCOR BCORL1 BRINP3 BRPF1 BUB1 CACNA1E CBL CBX5 CBX7 CDC73 CEP164 CPNE3 CSF1R CSTF2T CTCF CYLD DCLK1 DDX1 DDX23 DHX32 DIS3 DNAH9 DNMT1 DNMT3B DYRK4 EED EGFR EP300 EPHA2 EPHA3 ETV3 EZH2 FANCC GATA1 GATA2 GFI1 GLI1 HDAC2 HDAC3 HNRNPK HRAS IKZF1 JAK1 JAK2 JAK3 JMJD1C KDM2B KDM3B KDM6A KDM6B KMT2B KMT2C KRAS MAPK1 METTL3 MST1R MTA2 MTOR MXRA5 MYB MYC MYLK2 MYO3A NF1 NOTCH1 NOTCH2 NRAS NRK OBSCN PAPD5 PAX5 PDGFRA PDGFRB PDS5B PDSS2 PHF6 PKD1L2 PLRG1 POLR2A PRDM16 PRDM9 PRKCG PRPF3 PRPF40B PRPF8 PTEN PTPN11 PTPN14 PTPRT RAD21 RBBP4 RBMX RPS6KA6 SAP130 SCML2 SETBP1 SETD2 SF1 SF3A1 SF3B1 SMC1A SMC3 SMC5 SMG1 SNRNP200 SOS1 SPEN SRRM2 SRSF2 SRSF6 STAG2 STK32A STK33 STK36 SUDS3 SUMO2 SUPT5H SUZ12 TCF4 TET1 TET2 THRB TP53 TRA2B TRIO TTBK1 TYK2 TYW1 U2AF1 U2AF1L4 U2AF2 UBA3 WAC WAPAL WEE1 WNK3 WNK4 WT1 ZBTB33 ZBTB7B ZRSR2 56