A multianalyte algorithm PCR-based blood test outperforms single analyte ELISA-based blood tests for neuroendocrine tumor detection
Poster Mar 26, 2014
Mark Kidd, Irvin M Modlin, Daniele Alaimo, Stephen Callahan, Nancy Teixiera, Lisa Bodei, Ignat Drozdov
A key issue in management of neuroendocrine tumors (NETs) is specific and sensitive biomarkers. Measurements of single analytes in blood are widely utilized but have significant limitations. We developed a 51 transcript blood NET signature and compared it with standard approaches.
Methods: The multigene signature was evaluated in prospectively collected NETs (n=41, 61% small intestinal, 50% metastatic, 44% under treatment). These were age (NETs: mean 56.9 years, range: 31-76; controls: mean 56.4, range: 33-75) and sex-matched (M:F 10:31) with controls (1:1). Samples were analyzed by 2-step PCR protocol and ELISAs: (DAKO-CgA), pancreastatin (CusaBio-PST) and neurokinin A (RayBiotech-NKA). Sensitivity comparisons included chi-square, non-parametric measurements and ROC analyses.
Results: The NETest identified thirty eight of 41 NETs with equivalent performance metrics: sensitivity/specificity 93% and an AUC of 0.96. For the single analyte ELISA assays, metrics ranged from 31-93% and AUCs from 0.55-0.67. The multigene transcript NETest significantly outperformed single analyte tests (Z-statistic=4.85-6.58, p<0.0001).
Conclusions: A 51 panel multigene blood transcript analysis is significantly more sensitive and efficient (>93%) than any single analyte assay (CgA, PST or NKA) for NET detection. Our data indicate that a blood-based multigene analytic measurement will provide increased sensitivity and specificity in minimally invasive disease detection.
Despite the developments in conventional PCR, the complexity of multiplex Real Time PCR is still limited due to the lack of sufficient detection channels. To achieve high-end multiplexing capacity on standard Real Time PCR machines, Anapa Biotech has developed the MeltPlex® technology (see box on right).READ MORE