Sentosa® SQ Non-Small Cell Lung Cancer Panel
Detect sequence variants in NSCLC samples
The Sentosa SQ NSCLC 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 non-small cell lung cancer (NSCLC). 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 NSCLC 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 | 10 | 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 |
| System Control | 1 | NA | NA |
| Total | 28 | 113 |
Supporting Clinical Decision-Making:
- Minimal sample input of 5 ng DNA per library
- Automated and user-friendly result interpretation with Sentosa SQ Reporter
Providing Laboratory Efficiency:
- From clinical sample to result in two days
- 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 | 113 |
| Mean Coverage / Target | > 1,000 x |
| Analytical Sensitivity | ≥ 5 ng DNA input; 5% variant allele frequency for mutation detection |
| Clinical Sensitivitiy | 100% (95% CI: 95% to 100%) |
| Clinical Specificity | 100% (95% CI: 97.63% to 100%) |
| Reproducibility | ≥ 99.99% (95% CI: 99.96% to 100%) |
PRODUCT FLYERS
| Product | Pack Size | Item Number |
|---|---|---|
| Sentosa SQ NSCLC Panel Reagents (4x8) CE-IVD | 4x8 | 300356 |
| Sentosa SQ NSCLC Panel Reagents (4x8) RUO | 4x8 | 300357 |
| 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.
