oncoReveal™ CDx
Companion Diagnostic
oncoReveal™ CDx is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
This assay is an FDA-approved next generation sequencing test designed to detect single nucleotide variants (SNVs), insertions, and deletions in 22 genes associated with solid tumor malignancies. The test covers a comprehensive set of genes including AKT1, ALK, BRAF, CTNNB1, DDR2, EGFR, ERBB2, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, KRAS, MAP2K1, MET, NOTCH1, NRAS, PIK3CA, PTEN, SMAD4, STK11, and TP53, which are relevant for tumor diagnosis and treatment strategy development.
Special Instructions
- FFPE block preferred; unbaked slides acceptable. - Include a surgical pathology report with the sample to ensure complete and accurate results.
Limitations
The test is designed for detection of specified SNVs, insertions, and deletions only. It may not detect all mutations in the genes listed or mutations in genes not included in the panel. Insufficient tumor content or poor quality samples may also affect test performance and result accuracy. Analytical constraints are subject to biopharma protocol specifications.
FDA ApprovedCompanion Diagnostic
Methodology
NGS (Targeted)
Biomarkers
Result Turnaround Time
14 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
5 slides or scrolls (minimum 5-10 μM)
Container
10% NBF Fixed
Storage Instructions
Ambient temperature
Causes for Rejection
Improper specimen labeling; Insufficient tissue; Insufficient tumor burden; Insufficient DNA isolated
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinite at ambient temperature (15-25°C) |