Interpretation
Reported variants are clinically significant with respect to tumour type and therapeutic/diagnostic/prognostic interpretations (Tier 1 – PMID: 27993330) and have a frequency greater than 2.5%.
Clinical significance of variants is based on current medical and scientific knowledge and may change with future findings.
NOTE: This method does not distinguish between germline and somatic variants. If a germline variant is suspected, testing of the variant on a peripheral blood sample is recommended.
Reference Intervals
Genes/regions included in the Tumor-15 test
| Gene |
Region covered |
Cancers associated |
| AKT1 |
Exon 3 (partial) |
Breast |
| BRAF |
Exon 15 (partial) |
Melanoma, colon, lung |
| EGFR |
Focal amplification, exons 12 (partial), 18, 19, 20, 21 (partial) |
Lung |
| ERBB2 (HER2) |
Focal amplification, exons 14 (partial), 17, 18, 19, 20 (partial), 21 (partial), 24, 26 |
Breast, lung |
| FOXL2 |
Exon 1 (partial) |
Ovary |
| GNA11 |
Exon 5 (partial) |
Melanoma |
| GNAQ |
Exon 5 (partial) |
Melanoma |
| KIT |
Exons 8, 9, 10, 11, 13, 14, 17, 18 |
Gastric, melanoma |
| KRAS |
Exons 2 (partial), 3 (partial), 4 |
Colon, gastric, lung |
| MET |
Focal amplification |
Lung, colon, gastric |
| NRAS |
Exons 2 (partial), 3 (partial), 4 |
Colon |
| PDGFRA |
Exons 12, 14, 18 |
Gastric, melanoma |
| PIK3CA |
Exons 10, 21 |
Lung, breast, prostate |
| RET |
Exon 16 |
Lung |
| TP53 |
All coding exons |
Lung, melanoma, ovary, colon |
Test Method
DNA extracted from FFPE tissue or blood/bone marrow is analysed using the Illumina TruSight Tumor-15 assay (TS15). This assay uses next-generation sequencing (NGS) technology to provide a comprehensive assessment of 15 genes that are commonly mutated in solid tumors. This test can also be used for KIT gene variant detection in AML patients, BRAF gene variant detection in HCL patients and TP53 gene variant detection in CLL patients. Details of the genes and regions covered by the TS15 assay are shown above.
