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:
- OncoAlly™ Cancer Predisposition for hereditary cancer
- Genomic Unity® Pharmacogenomics Analysis for general pharmacogenomics.
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 |
| GSTP1 | *B |
| 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
