Table 3.
Phase 1b Results
| Phase 1b Samples | Variant Allelic Frequency. % | Mutation | Laboratory 1 (ddPCR) | Laboratory 2 (NGS - ThermoFisher Oncomine) | Laboratory 3 (NGS - Illumina TST15) | Laboratory 4 (Cobas EGFR Mutation Test v2) | Laboratory 5 (Cobas EGFR Mutation Test v2) |
|---|---|---|---|---|---|---|---|
| Sample 1 | 0.50 | EGFR T790M | T790M | T790M | T790M | T790M | T790M |
| Sample 2 | 5 | EGFR T790M | T790M | T790M | T790M | T790M | T790M |
| Sample 3 | 0.50 | EGFR T790M/L858R | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M |
| Sample 4 | 5 | EGFR T790M/L858R | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M |
| Sample 5 | 0 | EGFR Wild-type | None detected | None detected | None detected | None detected | None detected |
| Phase 1b Samples | Variant Allelic Frequency, % | Mutation | Laboratory 6 (Entrogen ctEGFR Mutation Detection kit) | Laboratory 7 (Entrogen ctEGFR Mutation Detection kit) | Laboratory 8 (Cobas EGFR Mutation Test v2) | Laboratory 9 (UltraSEEK Lung Panel) | Reference Center |
| Sample 1 | 0.50 | EGFR T790M | T790M | T790M | T790M | T790M | T790M |
| Sample 2 | 5 | EGFR T790M | T790M | T790M | T790M | T790M | T790M |
| Sample 3 | 0.50 | EGFR T790M/L858R | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M |
| Sample 4 | 5 | EGFR T790M/L858R | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M |
| Sample 5 | 0 | EGFR Wild-type | None detected | None detected | None detected | None detected | None detected |
ctEGFR, circulating tumor EGFR; ddPCR, droplet digital polymerase chain reaction; NGS, next-generation sequencing; TST15, TruSight Tumor 15.