Analytical validation of the Oncotype DX prostate cancer assay – a clinical RT-PCR assay optimized for prostate needle biopsies

Table 7 Performance of the RT-PCR positive control

Gene Assay	Mean	Median	SD
ARF1	22.7	22.7	0.20
ATP5E	24.3	24.2	0.33
AZGP1	24.6	24.6	0.23
BGN	23.7	23.7	0.22
CLTC	24.0	24.0	0.19
COL1A1	22.4	22.5	0.25
FAM13C1	25.8	25.8	0.23
FLNC	25.3	25.3	0.24
GPS1	25.3	25.3	0.20
GSN	25.9	25.9	0.29
GSTM2	26.7	26.7	0.21
KLK2	19.4	19.4	0.20
PGK1	26.3	26.3	0.22
SFRP4	26.7	26.7	0.23
SRD5A2	28.1	28.0	0.32
TPM2	22.6	22.6	0.21
TPX2	29.6	29.6	0.25

Summary statistics, including standard deviations for the RT-PCR positive control performance during analytical and clinical validation were calculated on the non-normalized scale. The plates were assembled using multiple PCR and liquid handling robots and by multiple operators, using multiple lots of critical reagents spanning a period of 20 weeks (N=54 individual Cp measurements).

ISSN: 1471-2164