Table 1. Limit of detection (LoD) for CLv2 and OLcfDNA panel determined with reference standard DNA extracted from synthetic plasma samples.
| AF Reference cfDNA | LoD | ||
|---|---|---|---|
| CLv2 | OLcfDNA | ||
| All 8 hotspot mutations | 5% | 16/16 | 16/16 |
| (100%) | (100%) | ||
| 1% | 14/16 | 16/16 | |
| (88%) | (100%) | ||
| 0.1% | 8/16 | 14/16 | |
| (50%) | (88%) | ||
| Point mutations | 5% | 12/12 | 12/12 |
| (100%) | (100%) | ||
| 1% | 12/12 | 12/12 | |
| (100%) | (100%) | ||
| 0.1% | 8/12 | 11/12 | |
| (67%) | (92%) | ||
| Insertions/Deletions | 5% | 4/4 | 4/4 |
| (100%) | (100%) | ||
| 1% | 3/4 | 4/4 | |
| (75%) | (100%) | ||
| 0.1% | 0/4 | 3/4 | |
| (0%) | (75%) | ||
| EGFR T790M | 5% | 2/2 | 2/2 |
| (100%) | (100%) | ||
| 1% | 2/2 | 2/2 | |
| (100%) | (100%) | ||
| 0.1% | 2/2 | 2/2 | |
| (100%) | (100%) | ||
AF: Allele Frequency; LoD: Limit of Detection.