Methodology
Molecular
Test Description and clinical significance
Genes
HOTSPOT GENES (57)
ACVR1, ATP1A1, BCR, BMP5 BTK CACNA1D CD79B CSF1R CTNNB1
CUL1 CYSLTR2 DGCR8 DROSHA E2F1 EPAS1 FGF7 FOXL2 FOXO1
GLI1 GNA11 GNAQ HIF1A HIST1H2BD HIST1H3B HRAS IDH1 IL6ST
IRF4 IRS4 KLF4 KNSTRN MAP2K2 MED12 MYOD1 NSD2 NT5C2
NTRK2 NUP93 PAX5 PIK3CD PIK3CG PTPRD RGS7 RHOA RPL10
SIX1 SIX2 SNCAIP SOS1 SOX2 SRSF2 STAT5B TAF1 TGFBR1
TRRAP TSHR WAS
CNV GAIN GENES (19)
ABCB1 CTNND2 DDR1 EMSY FGF19 FGF23 FGF3 FGF4 FGF9
FYN GLI3 IGF1R MCL1 MDM2 MYCL RPS6KB1 RPTOR YAP1
YES1
CNV AND HOTSPOT GENES (108)
ABL1 ABL2 AKT1 AKT2 AKT3 ALK AR ARAF AURKA
AURKC AXL BCL2 BCL2L12 BCL6 BRAF CARD11 CBL CCND1
CCND2 CCND3 CCNE1 CDK4 CDK6 CHD4 DDR2 EGFR EIF1AX
ERBB2 ERBB3 ERBB4 ESR1 EZH2 FAM135B FGFR1 FGFR2 FGFR3
FGFR4 FLT3 FLT4 FOXA1 GATA2 GNAS H3F3A H3F3B IDH2
IKBKB IL7R KDR KIT KLF5 KRAS MAGOH MAP2K1 MAPK1
MAX MDM4 MECOM MEF2B MET MITF MPL MTOR MYC
MYCN MYD88 NFE2L2 NRAS NTRK1 NTRK3 PCBP1 PDGFRA PDGFRB
PIK3C2B PIK3CA PIK3CB PIK3R2 PIM1 PLCG1 PPP2R1A PPP6C PRKACA
PTPN11 PXDNL RAC1 RAF1 RARA RET RHEB RICTOR RIT1
ROS1 SETBP1 SF3B1 SLCO1B3 SMC1A SMO SPOP SRC STAT3
STAT6 TERT TOP1 TPMT U2AF1 USP8 XPO1 ZNF217 ZNF429
CNV LOSS AND CDS GENES (205)
ABRAXAS1* ACVR1B ACVR2A ADAMTS12 ADAMTS2 AMER1 APC ARHGAP35 ARID1A
ARID1B ARID2 ARID5B ASXL1 ASXL2 ATM* ATR* ATRX AXIN1
AXIN2 B2M BAP1* BARD1* BCOR BLM* BMPR2 BRCA1* BRCA2*
BRIP1* CASP8 CBFB CD274 CD276 CDC73 CDH1 CDH10 CDK12*
CDKN1A CDKN1B CDKN2A CDKN2B CDKN2C CHEK1* CHEK2* CIC CREBBP
CSMD3 CTCF CTLA4 CUL3 CUL4A CUL4B CYLD CYP2C9 DAXX
DDX3X DICER1 DNMT3A DOCK3 DPYD DSC1 DSC3 ELF3 ENO1
EP300 EPCAM EPHA2 ERAP1 ERCC2 ERCC4 ERRFI1 ETV6 FANCA*
FANCC* FANCD2* FANCE* FANCF* FANCG* FANCI* FANCL* FANCM* FAT1
FBXW7 FUBP1 GATA3 GNA13 GPS2 HDAC2 HDAC9 HLA-A HLA-B
HNF1A INPP4B JAK1 JAK2 JAK3 KDM5C KDM6A KEAP1 KMT2A
KMT2B KMT2C KMT2D LARP4B LATS1 LATS2 MAP2K4 MAP2K7 MAP3K1
MAP3K4 MAPK8 MEN1 MGA MLH1 MLH3 MRE11* MSH2 MSH3
MSH6 MTAP MUTYH NBN* NCOR1 NF1 NF2 NOTCH1 NOTCH2
NOTCH3 NOTCH4 PALB2* PARP1* PARP2* PARP3* PARP4 PBRM1 PDCD1
PDCD1LG2 PDIA3 PGD PHF6 PIK3R1 PMS1 PMS2 POLD1* POLE*
POT1 PPM1D PPP2R2A* PRDM1 PRDM9 PRKAR1A PTCH1 PTEN* PTPRT
RAD50* RAD51* RAD51B* RAD51C* RAD51D* RAD52* RAD54L* RASA1 RASA2
RB1 RBM10 RECQL4 RNASEH2A* RNASEH2B* RNF43 RPA1* RUNX1 SDHA
SDHB SDHD SETD2 SLX4* SMAD2 SMAD4 SMARCA4 SMARCB1 SOX9
SPEN STAG2 STK11 SUFU TAP1 TAP2 TBX3 TCF7L2 TET2
TGFBR2 TNFAIP3 TNFRSF14 TP53 TP63 TPP2 TSC1 TSC2 USP9X
VHL WT1 XRCC2* XRCC3* ZFHX3 ZMYM3 ZRSR2
* Homologous recombination repair genes
CDS ONLY GENES (22)
CALR CIITA CYP2D6 ERAP2 ERCC5 FAS ID3 KLHL13 MTUS2
PSMB10 PSMB8 PSMB9 RNASEH2C* RPL22 RPL5 RUNX1T1 SDHC SOCS1
STAT1 TMEM132D UGT1A1 ZBTB20
GENE FUSIONS
FUSION DRIVER GENES (23)
ABL1 AKT3 ALK AXL BRAF EGFR ERBB2 ERG ETV1
ETV4 ETV5 FGFR1 FGFR2 FGFR3 MET NTRK1 NTRK2 NTRK3
PDGFRA PPARG RAF1 RET ROS1
Disease:
Solid tumors
An OncoSwift® Prelim Report (50 genes) +TMB, MSI, and LOH, in case genomic
alterations of strong clinical evidence were detected with a reflex to OncoSwift® Final Report (500 genes)
Specimen Requirements
Collection:
FFPE sections, 5-10 sections are recommended at 4 to 10 micron. A minimum of 20 ?L of each DNA with a concentration of at least 5 ng/?L and an OD260/280 ratio of 1.7-1.9, obtained on a spectrophotometer is required.
Stability:
FFPE blocks- Indefinitely/ FFPE Slides-4 weeks
Unacceptable Conditions:
Specimen submitted is in the incorrect fixative. Insufficient specimen (less than 10% of tumor). Unlabeled or improperly labeled specimens. Decalcified specimens. Improperly stored DNA.
Storage & Transport
Store FFPE blocks and slides at room temperature. Slides may be stored at ambient temperature for up to 4 weeks prior to DNA extraction. Genomic DNA must be stored at 2–8°C for several weeks post extraction, then at –15 to –25°C for long term.
CPT(s)
81455, 81459 (including MSI and TMB), G0452(26), 88381
New York Approved
Conditional approval
TAT
OncoSwift® Prelim Report (50 genes): ? 4-5 Days
OncoSwift® Final Report (500 genes): ? 7-10 Days
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
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