OncoAlly™ Solid Tumor Analysis

Test Code – OA0001

Test Description

OncoAlly™ is a solid tumor, pan-cancer test that analyzes the DNA and RNA of the tumor together with normal tissue to provide cancer treatment optimization. OncoAlly™ uses the patient’s health information and advanced analytics for genomic tumor profiling to generate comprehensive cancer treatment strategies in a concise, patient-centric report. Using whole genome sequencing, whole exome sequencing, and RNA analysis, OncoAlly™ analyzes genetic variants in over 430 cancer-associated genes and onco-pharmacogenomics in 9 genes predicting response to cancer-related drugs. 

Optional Add-ons:

Tumor Genetic Profiling 

  • Sequence changes, insertions and deletions, copy number variants, rearrangements, and fusions
  • Driver and resistance variants 
  • Immuno-oncology biomarkers: PD-L1, TMB, MSI
  • Cancer pharmacogenomics
  • Prognostic and diagnostic variants 
  • HPV status

Optimized Therapeutic Recommendations

  • Patient-centric report based on the genomic profile and patient health information
  • Prioritized therapeutic associations: FDA, NCCN, Investigational
  • Clinical trials matching
  • Focus on combination therapies
  • Personalized summary

When to Order

Order this test when molecular tumor profiling is needed to guide treatment selection and therapeutic guidance for a solid neoplasm.

  • 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 Analyses

Order this test when molecular tumor profiling is needed to guide treatment selection and therapeutic guidance for a solid neoplasm.

  • Genomic sequence analysis including insertions and deletions
  • Structural variants and copy number alterations
  • Chromosomal rearrangements
  • Germline sequence analysis 
  • Germline copy number variants analysis

Optionally Includes:

  • OncoAlly Cancer Predisposition
    • Germline variant detection in 88 genes related to hereditary cancer
  • Genomic Unity® Pharmacogenomics Analysis 
    • Germline variant detection of 13 genes reporting on a broad range of medications

Tumor Profiling Gene List

Onco-Pharamcogenomics Gene and Star Allele List

CYP2C8 *3
CYP2D6*4, *5, *10, *17, *29, *41
CYP3A5*1, *3
DPYD *2A, HapB3, D949V
NUDT15*2, *3, *9
SLCO1B1*5, *14, *15, *37
 TPMT*2, *3A, *3B, *3C
UGT1A1*6, *28

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.

Accepted Specimens

FFPE Samples

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)
In Variantyx collection kit

Normal Tissue

Streck Cell-Free DNA BCT tube (tiger top),
10 mL (*send sample within 2 days; do not freeze)
EDTA (purple top), 4mL
In Variantyx collection kit

Turn Around Time 

14 days from receipt of all samples

Contact Us

Please contact customer service to request a kit.

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