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A multianalyte algorithm PCR-based blood test outperforms single analyte ELISA-based blood tests for neuroendocrine tumor detection
EP21698
Poster Title: A multianalyte algorithm PCR-based blood test outperforms single analyte ELISA-based blood tests for neuroendocrine tumor detection
Submitted on 26 Mar 2014
Author(s): Mark Kidd, Irvin M Modlin, Daniele Alaimo, Stephen Callahan, Nancy Teixiera, Lisa Bodei, Ignat Drozdov
Affiliations: Wren Laboratories, 35 NE Industrial Road, Branford CT 06405
Poster Views: 3,315
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Poster Information
Abstract: 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.
Summary: In a prospective study, in age-/sex- and ethnicity-matched patients and controls (n=82), a 51 panel multigene blood transcript test (NETest) was identified to be significantly more sensitive and accurate (>93%) than any single analyte assay (Chromogranin A, Pancreastatin or Neurokinin A) for neuroendocrine tumor detection. References: 1. Modlin IM, Drozdov I, Kidd M. The Identification of gut neuroendocrine tumor disease by multiple synchronous transcript analysis in blood. PlosOne 2013; e63364
2. Modlin I, Drozdov I, Kidd M: Gut neuroendocrine tumor blood qpcr fingerprint assay: Characteristics and reproducibility. Clinical Chemistry 2014;52:419-429.
3. Modlin IM, Oberg K, Chung DC, et al. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol 2008; 9: 61-72
4. Kanakis G, Kaltsas G: Biochemical markers for g
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