Table 1.

Limit of blank and limit of detection of the ddEGFR test for mutant calls.

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 (%) = mean_{low concentration sample} + 1.645 (SD_{low 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.