OncoAlly® Solid Tumor Analysis

OA001

OncoAlly® Solid Tumor Analysis is a cancer treatment optimization test designed to provide FDA-approved and investigational therapy recommendations using comprehensive genomic profiling.

Test Description

OncoAlly® Solid Tumor Analysis is a pan-cancer test for solid tumors that uses a whole genome, whole exome and whole RNA transcriptome platform to detect clinically relevant-genomic variants and biomarkers from tumor and matched normal tissue samples. This targeted test focuses on 432 cancer-associated genes and 9 onco-pharmacogenomic genes.

OncoAlly® Solid Tumor Analysis provides a concise, patient-centric report designed to put actionable information in the hands of the tumor board. An interactive digital Report includes a personalized summary with prioritized therapy options focusing on combination therapies, cancer type-specific and advanced trials.

When to Order

Order this test when molecular tumor profiling is needed to guide treatment selection for a solid neoplasm including:

  • Following the diagnosis of any primary or metastatic solid tumor at any stage.
  • Following the diagnosis of primary recurrent or metastatic disease with or without known resistance factors.
  • When genomic tumor profiling is needed to determine appropriate FDA-approved therapies for a solid neoplasm.
  • After standard-of-care treatments have been ineffective in controlling tumor progression.
  • To identify eligibility for clinical trials based on genomic tumor profiling and patient health history.

Included Genes

Cancer-associated genes
ABL2, ABRAXAS1, ACVR1, AJUBA, AKT1, AKT2, AKT3, ALK, AMER1, APC, AR, ARAF, ARID1A, ARID2, ASXL1, ATM, ATR, ATRX, AURKA, AURKB, AURKC, AXIN2, AXL, B2M, BAP1, BARD1, BCL2, BCL2A1, BCL2L1, BCL2L11, BCL3, BCL6, BCL10, BCL11A, BCOR, BCORL1, BIRC2, BIRC3, BLM, BMPR1A, BRAF, BRCA1, BRCA2, BRD1, BRD2, BRD4, BRIP1, BTG1, BTG2, BTK, CAD, CALR, CARD11, CBFB, CBL, CCDC6, CCND1, CCND2, CCND3, CCNE1, CD274, CDC73, CDH1, CDK2, CDK4, CDK6, CDK7, CDK8, CDK9, CDK12, CDKN1A, CDKN1B, CDKN2A, CDKN2B, CDKN2C, CEBPA, CHD2, CHEK1, CHEK2, CIC, CIITA, CREBBP, CRKL, CSF1R, CSF3R, CTCF, CTLA4, CTNNA1, CTNNB1, CUL3, CXCR4, CYLD, DAXX, DDIT3, DDR1, DDR2, DDX41, DICER1, DNMT3A, DRD2, EBF1, ECT2, ECT2L, EED, EGFR, EIF1AX, ELF3, ELOC (TCEB1), EML4, EMSY, EP300, EPCAM, EPHA2, ERBB2, ERBB3, ERBB4, ERCC2, ERCC3, ERCC4, ERCC5, ERG, ERRFI1, ESR1, ETV1, ETV4, ETV5, ETV6, EWSR1, EZH2, FANCA, FANCC, FANCD2, FAS, FAT1, FBXO11, FBXW7, FGF3, FGF4, FGF6, FGF10, FGF19, FGF23, FGFR1, FGFR2, FGFR3, FGFR4, FH, FLCN, FLT1, FLT3, FLT4, FOLR1, FOXA1, FOXA2, FOXL2, FOXO1, FOXP1, FRS2, FUBP1, GALNT12, GATA1, GATA2, GATA3, GATA4, GATA6, GLI1, GNA11, GNA13, GNAQ, GNAS, GRIN2A, GSK3B, H3F3A, H3F3B, HDAC1, HDAC2, HDAC3, HDAC6, HIF1A, HIST1H3B, HIST1H3C, HNF1A, HOXB13, HRAS, ID3, IDH1, IDH2, IGF1R, IGF2, IKBKE, IKZF1, IKZF2, IKZF3, IL7R, INPP4B, INSR, IRF1, IRF4, IRS2, ITK, JAK1, JAK2, JAK3, JARID2, JUN, KDM5A, KDM5C, KDM6A, KDR, KEAP1, KIT, KLF5, KLHL6, KMT2A, KMT2B, KMT2C, KMT2D, KRAS, LCK, LMO1, LYN, LZTR1, MALT1, MAML2, MAP2K1, MAP2K2, MAP2K4, MAP3K1, MAP3K7, MAP3K14, MAPK1, MAPK3, MAPK4, MAPK7, MAX, MCL1, MDM2, MDM4, MECOM, MED12, MEF2B, MEF2C, MEN1, MERTK, MET, MGMT, MITF, MLH1, MLLT3, MPL, MRE11, MSH2, MSH3, MSH6, MST1R, MTAP, MTOR, MUTYH, MYC, MYCL, MYCN, MYD88, NBN, NCOA1, NCOA2, NCOR1, NF1, NF2, NFE2L2, NFKBIA, NOTCH1, NOTCH2, NOTCH3, NRAS, NSD1, NT5C2, NTHL1, NTRK1, NTRK2, NTRK3, NUP98, NUP214, P2RY8, PALB2, PAX3, PAX7, PBRM1, PDCD1, PDGFRA, PDGFRB, PHF1, PHF6, PHOX2B, PIK3CA, PIK3CB, PIK3CD, PIK3CG, PIK3R1, PIK3R2, PIM1, PLAG1, PLCG1, PLCG2, PLK1, PMS2, POLD1, POLE, POT1, PPARG, PPP2R1A, PRKAR1A, PRKDC, PRKG1, PTCH1, PTEN, PTK2, PTK6, PTPN6, PTPN11, PTPRD, PTPRO, PTPRT, RAC1, RAD21, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RAF1, RARA, RASGEF1A, RB1, RBM10, RECQL4, REL, RELN, RET, RHOA, RICTOR, RIT1, RNF43, ROS1, RPL5, RPS6KB2, RPTOR, RUNX1, RUNX1T1, SDHA, SDHAF2, SDHB, SDHC, SDHD, SEC23B, SETBP1, SETD2, SF3B1, SGK1, SH2B3, SH2D1A, SIK1, SIN3A, SLAMF7, SLX4, SMAD2, SMAD3, SMAD4, SMARCA1, SMARCA4, SMARCB1, SMC3, SMO, SOCS1, SOX2, SOX9, SPEN, SPOP, SPRED1, SRC, SRSF2, STAG2, STAT3, STAT5A, STAT5B, STAT6, STK11, SUFU, SUZ12, SYK, TAF1, TBL1XR1, TCF3, TEK, TENT5C, TERT, TET1, TET2, TGFBR2, TLR4, TMEM30A, TMEM127, TMPRSS2, TNFAIP3, TNFRSF14, TNFRSF17, TNFSF11, TOP1, TP53, TP53BP1, TP63, TRAF3, TRAF7, TSC1, TSC2, TSHR, TYRO3, U2AF1, U2AF2, USP9X, VEZF1, VHL, WEE1, WRN, WT1, XBP1, XPO1, ZNF217, ZNF423, ZNF521, ZNF703, ZRSR2

Cancer pharmacogenomic genes
CYP2C8, CYP2D6, CYP3A5, DPYD, GSTP1, NUDT15, SLCO1B1, TPMT, UGT1A1

Included Analyses

  • Sequence analysis of cancer-associated genes including: single nucleotide variants, deletions, insertions, and splicing variants.
  • Structural variants analysis of cancer-associated genes including: copy number alterations (CNA), fusions and other rearrangements.
  • Immunotherapy marker analysis including: MS status (MSI/MSS), TMB, PD-L1 (available add-on).
  • Pharmacogenomic star allele analysis including: 26 alleles (9 genes) relevant to oncology drugs.
  • Analysis of germline variants with FDA-approved therapies.
  • HPV status
  • MGMT promoter methylation (available add-on for malignant glioma).

Optionally includes:


Turnaround Time

A report will be issued within 14 days from receipt of required samples.

Sample Types

Tumor tissues:

  • FFPE
    • 10-20 unstained slides* (positively charged and unbaked), 5-10 micron thick + one terminal H&E (preferred)
    • Scroll, 3 x 20 micron OR 1 x 50 micron thick + 1 H&E
    • ≥30% tumor optimal; 20% tumor minimum
    • Tissue size: 25mm-2 optimal, minimum 5mm-2 (biopsy)

Normal tissue:

  • Blood

    5ml

* For PD-L1: Five additional unstained slides (positively charged and unbaked) are required.

* For MGMT promoter methylation: Five additional unstained slides (positively charged and unbaked) are required.

CPT Codes

81455

The CPT codes provided 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.

Methods and Limitations

OncoAlly® Solid Tumor Analysis uses a PCR-free whole genome sequencing (WGS), whole exome sequencing (WES) and whole transcriptome RNA sequencing platform paired with our ClaudIA for Genomics™ precision oncology software.

Minimum average on-target read depth coverages are:

  • Tumor FFPE by whole genome sequencing, 20X.
  • Matched normal blood whole genome sequencing, 20X.
  • Tumor FFPE by whole exome sequencing, 200X.
  • Matched normal blood whole exome sequencing, 80X.
  • Tumor FFPE RNA sequencing, 50X.

This test is only appropriate for solid malignancies.