Sentosa® SQ Colorectal Cancer Panel
Detect sequence variants in colorectal cancer samples
The Sentosa SQ CRC Panel is a next-generation sequencing (NGS)-based in vitro diagnostic test that simultaneously detects hot spot mutations in 11 genes from formalin-fixed paraffin-embedded (FFPE) samples that have previously demonstrated clinical relevance in the management of patients with colorectal cancer (CRC). This panel is intended to be used on the Sentosa SX101 with the Sentosa SX FFPE II gDNA Kit in conjunction with the Sentosa ST401 and Sentosa SQ301 instruments.
The Sentosa SQ CRC Panel is intended to be used as a test to aid the oncologist in clinical decision-making. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test or disease monitoring.
| Target Genes | Number of Amplicons | Number of Target Mutations | Amplicon Locations in Exon(s) |
|---|---|---|---|
| NRAS | 3 | 19 | 2, 3, 4 |
| CTNNB1 | 1 | 5 | 3 |
| PIK3CA | 2 | 14 | 11, 22 |
| FGFR3 | 3 | 9 | 7, 9, 14 |
| KIT | 3 | 8 | 11, 13, 17 |
| EGFR | 4 | 9 | 18, 19, 20, 21 |
| BRAF | 2 | 15 | 11, 15 |
| RET | 1 | 1 | 16 |
| PTEN | 3 | 3 | 5, 7 |
| KRAS | 3 | 22 | 2, 3, 4 |
| TP53 | 3 | 7 | 4, 6, 7 |
| Total | 28 | 112 |
Supporting Clinical Decision-Making
- Minimal sample input - 10μm section of FFPE tissue or 5 ng DNA per library
- Automated and user-friendly data analysis and results reporting with Sentosa SQ Reporter
Providing Laboratory Efficiency
- From clinical sample to result in two days
- Reproducibility of 99.89% with detection of up to 5% variant frequency
- Seamless sample traceability and IT connectivity
| Attribute | Value |
|---|---|
| Sample Input | 10 μm section of FFPE tissue (on glass slide or scroll) |
| Target Amplicons | 28 targets and 1 control |
| Target Mutations | 112 |
| Min. Coverage / Target Mutation | > 1,000 x |
| Analytical Sensitivity | ≥ 5 ng DNA input; 5% variant frequency for mutation detection |
| Clinical Sensitivity | 100% (95% CI: 95.31% to 100%) |
| Clinical Specificity | 100% (95% CI: 94.34% to 100%) |
| Reproducibility | ≥ 99.89% (95% CI: 99.82% to 99.93%) |
| Product | Pack Size | Item Number |
|---|---|---|
| Sentosa SQ CRC Panel Reagents (4x8) CE-IVD | 4x8 | 300261 |
| Sentosa SQ CRC Panel Reagents (4x8) RUO | 4x8 | 300262 |
| Sentosa SQ Oncology Solutions (4x8) CE-IVD | 4x8 | 300336 |
| Sentosa SQ Oncology Solutions (4x8) RUO | 4x8 | 300224 |
For availability in your country, please contact your Vela Diagnostics sales representative. Availability is subject to country's regulatory approval.
