Table 1.
Exon | Mutations detected | Mutation report call | LoB copies/MI (%)* | LoD MI (%)† |
---|---|---|---|---|
18 | G719A, G719C, G719S | G719X | 5.6/0.22 | 0.77 |
19 | 30 deletions | 19del | 3.0/0.09 | 0.83 |
20 | S768I | S768I | 1.5/0.05 | 0.83 |
T790M | T790M | 6.8/0.34 | 0.78 | |
C797S§ | C797S | 1.6/0.03 | 0.75 | |
5 Insertions | E20Ins | 1.6/0.06 | 0.62 | |
21 | L858R | L858R | 1.6/0.03 | 0.71 |
L861Q | L861Q | 1.4/0.05 | 0.74 |
*LoB = mean blank + 1.645 (SD blank)36.
†LoD MI (%) = meanlow concentration sample + 1.645 (SDlow concentration sample).
§Using plasmids containing the non-predominant mutation for analytical performance.
LoB was calculated using 9.9 ng of normal FFPET-DNA. LoD was measured at 6 points (3–0.1%) serially diluted using NSCLC FFPET-DNA (19del, L858R) and reference standard FFPET-DNA (the other mutations) with wild-type FFPE-DNA. LoD was determined by the lowest amount of DNA that gave an EGFR “Mutation Detected” rate of at least 95% for the target mutation.