Translating tumor biology into personalized treatment planning: analytical performance characteristics of the Oncotype DX®Colon Cancer Assay

Table 2 Linear range

Gene	Linear Range	Quadratic p-value	Cubic p-value	Maximum Absolute Deviation from Linearity (C_T)
ATP5E	2 ^-10 to 2⁵ ng	< 0.01	< 0.01	0.44
BGN	2 ^-9 to 2⁵ ng	< 0.01	< 0.01	0.17
MYC	2 ^-10 to 2⁵ ng	< 0.01	0.11	0.86
FAP	2 ^-7 to 2⁵ ng	< 0.01	< 0.01	0.74
GADD45B	2 ^-7 to 2⁵ ng	< 0.01	0.01	0.38
GPX1	2 ^-10 to 2⁵ ng	< 0.01	0.04	0.30
INHBA	2 ^-7 to 2⁵ ng	< 0.01	< 0.01	0.99
MK167	2 ^-7 to 2⁵ ng	< 0.01	< 0.01	0.17
MYBL2	2 ^-6 to 2⁵ ng	< 0.01	0.81	0.43
PGK1	2 ^-8 to 2⁵ ng	< 0.01	< 0.01	0.56
UBB	2 ^-10 to 2⁵ ng	< 0.01	0.08	0.36
VDAC2	2 ^-10 to 2⁵ ng	< 0.01	< 0.01	0.23

Using the aggregated, non-normalized C_T values from the 17-point serial dilution, the linearity of C_T value as a function of RNA concentration was evaluated for each gene. All genes demonstrated a maximum deviation from linearity less than 1 C_T over at least an 11 log₂ concentration range (2^-6 to 2⁵).

ISSN: 1471-2407