oncoReveal® CDx
Pan-Cancer Solid Tumor IVD
FDA Approved
oncoReveal™ CDx is an FDA PMA-approved, NGS-based companion diagnostic (CDx) kit providing comprehensive genomic results, covering 22 clinically relevant genes. oncoReveal CDx has a single-tube workflow that can be performed by any clinical laboratory, providing sample-to-clinical report in less than 48 hours.
oncoReveal CDx has been clinically and analytically validated across all major solid tumors. The assay kit is designed to provide clinically actionable information — both to consider appropriate CDx therapies in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), and to aid in the identification of other clinically significant genomic alterations for patients with solid tumors.
Table 1: Approved Companion Diagnostic and Tumor-Profiling Indications
| TUMOR TYPES | BIOMARKERS | FDA APPROVED TARGETED THERAPY |
|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | EGFR Exon 19 in Frame Deletions and Exon 21 L858R Substitution Mutations | All EGFR Tyrosine Kinase Inhibitors approved by FDA |
| Colorectal Cancer (CRC) | KRAS wild-type (absence of mutations in codons 12 and 13) | Erbitux® (cetuximab), or Vectibix® (panitumumab) |
| Pan-Cancer Solid Tumor (NSCLC, CRC, Breast, Melanoma, Ovarian, Endometrial, Renal, Liver, Bladder, Thyroid, Pancreatic, Brain, other) | General tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms. | |
Table 2: oncoReveal® CDx gene list*
| AKT1 | ALK | BRAF | CTNNB1 | DDR2 | EGFR | ERBB2 | ERBB4 |
| FBXW7 | FGFR1 | FGFR2 | FGFR3 | KRAS | MAP2K1 | MET | NOTCH1 |
| NRAS | PIK3CA | PTEN | SMAD4 | STK11 | TP53 |
| AKT1 | BRAF | DDR2 | ERBB2 |
| FBXW7 | FGFR2 | KRAS | MET |
| NRAS | PTEN | STK11 | ERBB4 |
| ALK | CTNNB1 | EGFR | NOTCH1 |
| FGFR1 | FGFR3 | MAP2K1 | |
| PIK3CA | SMAD4 | TP53 |
*Genes with CDx claims noted in green
Simple NGS Library Prep Workflow
Maintain control of samples and results with single-tube, tiled amplification that can be performed in-house by any NGS labSensitive and Robust Chemistry
Achieve variant detection as low as 1% VAF* even with limited DNA input or poor sample qualityReduced Fully-Loaded Lab Costs
Improve lab efficiency and reduce “no calls”, repeat testing, and difficult interpretation decisions*VAF, variant allele frequency
For Research Use Only. Not for use in diagnostic procedures..
oncoReveal CDx Technical Specifications
| Enrichment chemistry | Multiplex PCR using tiled amplicons |
| Number of pools | 1 pool |
| Number of genes/amplicons | 22/103 |
| Number of targets | >1800 hotspots covering >3600 DNA variants |
| Variant types | SNVs/Indels |
| Recommended DNA input | 30 – 80 ng |
| % Tumor Nuclei Required | ≥ 30% tumor nuclei |
| Sample type | DNA from FFPE |
| Validated NGS platform | Illumina MiSeq™Dx |
Ordering Information
| ITEM | PART NUMBER |
|---|---|
| oncoReveal® CDx 48 reaction kit | HDA-LC-2001-48 |
| Cyber secure oncoReveal® CDx PiVAT® workstation | SFW-2012 |
| Pillar MiSeq™Dx LRM Module | SFW-2008 |