OncoAlly™ Solid Tumor Analysis
Test Code – OA001
Test Description
OncoAlly™ Solid Tumor Analysis is a pan-cancer treatment optimization test designed to provide FDA-approved and investigational therapy recommendations using comprehensive genomic profiling. It uses a whole genome, whole exome and whole RNA transcriptome platform to detect clinically relevant genetic variants and biomarkers from tumor and matched normal tissue samples.
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 Analyses
- Sequence analysis of cancer-associated genes including: single nucleotide variants, deletions, insertions, and splicing variants
- Structural variant analysis of cancer-associated genes including: copy number alterations (CNA), rearrangements, fusions
- Immunotherapy marker analysis including: MS status (MSI/MSS), TMB, PD-L1 (available add-on)
- Pharmacogenomic allele analysis including: 26 alleles (9 genes) relevant to oncology drugs
- Analysis of germline variants with FDA-approved therapies
- Cancer-type specific biomarkers including: HPV status and MGMT promoter methylation
Optionally Includes:
- OncoAlly™ Cancer Predisposition for broader analysis of germline variants
- Genomic Unity® Pharmacogenomics Analysis for broader analysis of pharmacogenomic variants
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
Included Tumor Profiling Genes
Included Onco-Pharmacogenomic Genes and Star Alleles
| 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)
*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.
Normal Tissue
Streck Cell-Free DNA BCT tube (tiger top),
10 mL (*send sample within 2 days; do not freeze)
EDTA (purple top), 4mL
Or
Blood, 5ml
Turn Around Time
A report will be issued within 14 days from receipt of required samples.
