Table 2.
Phase 1a Results
| Phase 1a Samples | Mutation | Mutant Allelic Frequency, % | 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 | EGFR T790M | 0.05 | None detected | None detected | None detected | None detected | None detected |
| Sample 2 | EGFR T790M | 0.50 | T790M | T790M | T790M | T790M | T790M |
| Sample 3 | EGFR T790M | 5 | T790M | T790M | T790M | T790M | T790M |
| Sample 4 | EGFR L858R | 0.05 | L858R | L858R | None detected | None detected | None detected |
| Sample 5 | EGFR L858R | 0.50 | L858R | L858R | L858R | L858R | L858R |
| Sample 6 | EGFR L858R | 5 | L858R | L858R | L858R | ΔE746-A750+L858R | ΔE746-A750+L858R |
| Sample 7 | EGFR ΔE746-A750 | 0.05 | None detected | None detected | None detected | ΔE746-A750 | ΔE746-A750 |
| Sample 8 | EGFR ΔE746-A750 | 0.50 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 |
| Sample 9 | EGFR ΔE746-A750 | 5 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 |
| Sample 10 | EGFR T790M/L858R | 0.05 | L858R | T790M | None detected | None detected | None detected |
| Sample 11 | EGFR T790M/L858R | 0.50 | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M |
| Sample 12 | EGFR T790M/L858R | 5 | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M |
| Sample 13 | EGFR Wild-type | 0 | None detected | None detected | None detected | None detected | None detected |
| Phase 1a Samples | Mutation | Mutant Allelic Frequency, % | 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) | |
| Sample 1 | EGFR T790M | 0.05 | None detected | None detected | T790M | None detected | |
| Sample 2 | EGFR T790M | 0.50 | T790M | T790M | T790M | T790M | |
| Sample 3 | EGFR T790M | 5 | T790M | T790M | T790M | T790M | |
| Sample 4 | EGFR L858R | 0.05 | L858R | None detected | None detected | None detected | |
| Sample 5 | EGFR L858R | 0.50 | L585R | L858R | L858R | L858R | |
| Sample 6 | EGFR L858R | 5 | L5858R | L858R | ΔE746-A750+L858R | L858R | |
| Sample 7 | EGFR ΔE746-A750 | 0.05 | None detected | None detected | ΔE746-A750 | None detected | |
| Sample 8 | EGFR ΔE746-A750 | 0.50 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 | |
| Sample 9 | EGFR ΔE746-A750 | 5 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 | ΔE746-A750 | |
| Sample 10 | EGFR T790M/L858R | 0.05 | L858R+T790M | None detected | None detected | None detected | |
| Sample 11 | EGFR T790M/L858R | 0.50 | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M | |
| Sample 12 | EGFR T790M/L858R | 5 | L858R+T790M | L858R+T790M | L858R+T790M | L858R+T790M | |
| Sample 13 | EGFR Wild-type | 0 | 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.