A summary of the results from the validation of Idylla against Ion Torrent (Ion) NGS and IHC for BRAF, KRAS and NRAS
| BRAF | |||
|---|---|---|---|
| Ion NGS BRAF mutant | Ion NGS BRAF wild type | Total | |
| Idylla BRAF+ | 8 | 0 | 8 |
| Idylla BRAF− | 0 | 9 | 9 |
| Total | 8 | 9 | 17 |
| VE1 IHC BRAF mutant | VE1 IHC BRAF wild type | Total | |
| Idylla BRAF+ | 10 | 0 | 10 |
| Idylla BRAF− | 2* | 8 | 10 |
| Total | 12 | 8 | 20 |
| Idylla concordance with IHC: 90% (95% CI 70% to 97%) | |||
| Idylla concordance with Ion NGS: 100% (95% CI 82% to 100%) | |||
| Idylla sensitivity (vs Ion NGS): 100% (95% CI 68% to 100%) | |||
| Idylla specificity (vs Ion NGS): 100% (95% CI 70% to 100%) | |||
| KRAS | |||
| Ion NGS KRAS mutant | Ion NGS KRAS wild type | Total | |
| Idylla KRAS+ | 9 | 0 | 9 |
| Idylla KRAS− | 0 | 9 | 9 |
| Total | 9 | 9 | 18 |
| Idylla concordance: 100% (95% CI 82% to 100%) | |||
| Idylla sensitivity: 100% (95% CI 70% to 100%) | |||
| Idylla specificity: 100% (95% CI 70% to 100%) | |||
| NRAS | |||
| Ion NGS NRAS mutant | Ion NGS NRAS wild type | Total | |
| Idylla NRAS+ | 5 | 1† | 6 |
| Idylla NRAS− | 0 | 11 | 11 |
| Total | 5 | 12 | 17 |
| Idylla concordance with Ion NGS: 94% (95% CI 73% to 99%) Idylla sensitivity: 100% (95% CI 57% to 100%) Idylla specificity: 92% (95% CI 65% to 99%) | |||
| All targets | |||
| Ion NGS/ddPCR mutant | Ion NGS wild type | Total | |
| Idylla+ | 24 | 0 | 24 |
| Idylla− | 0 | 28 | 28 |
| Total | 24 | 28 | 52 |
| Idylla concordance with Ion NGS/ddPCR: 100% (95% CI 93% to 99%) Idylla sensitivity: 100% (95% CI 86% to 100%) Idylla specificity: 100% (95% CI 88% to 99%) | |||
*Found to be wild type by Cobas PCR.
†Found to be positive for a mutation by ddPCR.
ddPCR, droplet digital polymerase chain reaction; IHC, immunohistochemistry; NGS, next-generation sequencing.