Multi-gene NGS assay for targeted therapy selection
- Tissue-based (FFPE) sample: Actionable mutations for 12 cancers types. Drugs recommendation & drugs resistance mechanism based on FDA guidelines.
- ctDNA blood sample: Apply only for Lung (NSCLC), Breast, Colorectal, Ovarian & Gastric cancers. (Contact us for technical specification variations) (*)
(*) (Tran, Le Son, et al. 'Ultra-deep massively parallel sequencing with unique molecular identifier tagging achieves comparable performance to droplet digital PCR for detection and quantification of circulating tumor DNA from lung cancer patients.' PLoS One 14.12 (2019): e0226193.)
High Accuracy for Reliable Results
| FFPE Sample | Sensitivity | Specificity | LOD (%VAF) |
|---|---|---|---|
| SNVs/INDELs | 94.6% | >99.0% | 1% |
| Fusions | 94.0% | >99.0% | 1% |
| Amplifications | 95.0% | 97% | — |
| Blood Sample | Sensitivity | Specificity | LOD (%VAF) |
|---|---|---|---|
| SNVs/INDELs | 91.2% | >99.0% | 0.1% |
| Fusions | >99.0% | >99.0% | 1% |
| For fusions with VAF 0.01-1%, sensitivity may decrease to -66% | |||
LOD = limit of detection; VAF = variant allele frequency
1. Tran LS, Pham HAT, Tran VU, et al. Ultra-deep massively parallel sequencing with unique molecular identifier tagging achieves comparable performance to droplet digital PCR for detection and quantification of circulating tumor DNA from lung cancer patients. PLoS ONE. 2019;14(12):e0226193. doi:10.1371/journal.pone.0226193.
2. Hoang TPN, Nguyen TA, Tran NHB, et al. Analytical validation and clinical utilization of K-4CARETM: a comprehensive genomic profiling assay with personalized MRD detection. Frontiers in Molecular Biosciences. 2024;11. doi:10.3389/fmolb.2024.1334808
Scope of the test
Testing candidates
Lung
cancer patient
Formalin fixed paraffin embedded (FFPE) tissue/blood/pleural fluid
Breast/Ovarian
cancer patient
Formalin fixed paraffin embedded (FFPE) tissue/blood
Colorectal/Gastric
cancer patient
Formalin fixed paraffin embedded (FFPE) tissue/blood
GIST
cancer patient
Formalin fixed paraffin embedded (FFPE) tissue
Thyroid gland
cancer patient
Formalin fixed paraffin embedded (FFPE) tissue
Pancreas/Prostate
cancer patient
Formalin fixed paraffin embedded (FFPE) tissue
Solid tumor/Melanoma
cancer patient
Formalin fixed paraffin embedded (FFPE) tissue
Erdheim-Chester, Langerhans cell, Rosai-Dorfman histiocytosis
cancer patient
Formalin fixed paraffin embedded (FFPE) tissue
Testing process
Complete the Consent Form and collect FFPE (Formalin-Fixed Paraffin-Embedded) samples or blood samples or pleural fluid samples.
Multi-gene sequence explanation (insertion-deletion mutations, gene fusion, gene amplification).
Identify mutations and drug resistance based on approvals from the U.S. Food and Drug Administration (FDA) and recommendations from the National Comprehensive Cancer Network (NCCN).
