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NETest is superior to chromogranin A in neuroendocrine neoplasia: a prospective ENETS CoE analysis

INTRODUCTION: The absence of a reliable, universal biomarker is a significant limitation in neuroendocrine neoplasia (NEN) management. We prospectively evaluated two CgA assays, (NEOLISA, EuroDiagnostica) and (CgA ELISA, Demeditec Diagnostics (DD)) and compared the results to the NETest. METHODS: NE...

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Autores principales: Malczewska, Anna, Oberg, Kjell, Kos-Kudla, Beata
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Bioscientifica Ltd 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923057/
https://www.ncbi.nlm.nih.gov/pubmed/33289691
http://dx.doi.org/10.1530/EC-20-0417
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author Malczewska, Anna
Oberg, Kjell
Kos-Kudla, Beata
author_facet Malczewska, Anna
Oberg, Kjell
Kos-Kudla, Beata
author_sort Malczewska, Anna
collection PubMed
description INTRODUCTION: The absence of a reliable, universal biomarker is a significant limitation in neuroendocrine neoplasia (NEN) management. We prospectively evaluated two CgA assays, (NEOLISA, EuroDiagnostica) and (CgA ELISA, Demeditec Diagnostics (DD)) and compared the results to the NETest. METHODS: NEN cohort (n = 258): pancreatic, n = 67; small intestine, n = 40; appendiceal, n = 10; rectal, n = 45; duodenal, n = 9; gastric, n = 44; lung, n = 43. Image-positive disease (IPD) (n = 123), image & histology- negative (IND) (n = 106), and image-negative and histology positive (n = 29). CgA metrics: NEOLISA, ULN: 108 ng/mL, DD: ULN: 99 ng/mL. Data mean ± s.e.m. NETest: qRT-PCR – multianalyte analyses, ULN: 20. All samples de-identified and assessed blinded. Statistics: Mann–Whitney U-test, Pearson correlation and McNemar-test. RESULTS: CgA positive in 53/258 (NEOLISA), 32 (DD) and NETest-positive in 157/258. In image- positive disease (IPD, n = 123), NEOLISA-positive: 33% and DD: 19%. NETest-positive: 122/123 (99%; McNemar’s Chi2= 79–97, P < 0.0001). NEOLISA was more accurate than DD (P = 0.0003). In image- negative disease (IND), CgA was NEOLISA-positive (11%), DD (8%), P = NS, and NETest (33%). CgA assays could not distinguish progressive (PD) from stable disease (SD) or localized from metastatic disease (MD). NETest was significantly higher in PD (47 ± 5) than SD (29 ± 1, P = 0.0009). NETest levels in MD (35 ± 2) were elevated vs localized disease (24 ± 1.3, P = 0.008). CONCLUSIONS: NETest, a multigenomic mRNA biomarker, was ~99% accurate in the identification of NEN disease. The CgA assays detected NEN disease in 19–33%. Multigenomic blood analysis using NETest is more accurate than CgA and should be considered the biomarker standard of care.
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spelling pubmed-79230572021-03-05 NETest is superior to chromogranin A in neuroendocrine neoplasia: a prospective ENETS CoE analysis Malczewska, Anna Oberg, Kjell Kos-Kudla, Beata Endocr Connect Research INTRODUCTION: The absence of a reliable, universal biomarker is a significant limitation in neuroendocrine neoplasia (NEN) management. We prospectively evaluated two CgA assays, (NEOLISA, EuroDiagnostica) and (CgA ELISA, Demeditec Diagnostics (DD)) and compared the results to the NETest. METHODS: NEN cohort (n = 258): pancreatic, n = 67; small intestine, n = 40; appendiceal, n = 10; rectal, n = 45; duodenal, n = 9; gastric, n = 44; lung, n = 43. Image-positive disease (IPD) (n = 123), image & histology- negative (IND) (n = 106), and image-negative and histology positive (n = 29). CgA metrics: NEOLISA, ULN: 108 ng/mL, DD: ULN: 99 ng/mL. Data mean ± s.e.m. NETest: qRT-PCR – multianalyte analyses, ULN: 20. All samples de-identified and assessed blinded. Statistics: Mann–Whitney U-test, Pearson correlation and McNemar-test. RESULTS: CgA positive in 53/258 (NEOLISA), 32 (DD) and NETest-positive in 157/258. In image- positive disease (IPD, n = 123), NEOLISA-positive: 33% and DD: 19%. NETest-positive: 122/123 (99%; McNemar’s Chi2= 79–97, P < 0.0001). NEOLISA was more accurate than DD (P = 0.0003). In image- negative disease (IND), CgA was NEOLISA-positive (11%), DD (8%), P = NS, and NETest (33%). CgA assays could not distinguish progressive (PD) from stable disease (SD) or localized from metastatic disease (MD). NETest was significantly higher in PD (47 ± 5) than SD (29 ± 1, P = 0.0009). NETest levels in MD (35 ± 2) were elevated vs localized disease (24 ± 1.3, P = 0.008). CONCLUSIONS: NETest, a multigenomic mRNA biomarker, was ~99% accurate in the identification of NEN disease. The CgA assays detected NEN disease in 19–33%. Multigenomic blood analysis using NETest is more accurate than CgA and should be considered the biomarker standard of care. Bioscientifica Ltd 2020-12-03 /pmc/articles/PMC7923057/ /pubmed/33289691 http://dx.doi.org/10.1530/EC-20-0417 Text en © 2021 The authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/) .
spellingShingle Research
Malczewska, Anna
Oberg, Kjell
Kos-Kudla, Beata
NETest is superior to chromogranin A in neuroendocrine neoplasia: a prospective ENETS CoE analysis
title NETest is superior to chromogranin A in neuroendocrine neoplasia: a prospective ENETS CoE analysis
title_full NETest is superior to chromogranin A in neuroendocrine neoplasia: a prospective ENETS CoE analysis
title_fullStr NETest is superior to chromogranin A in neuroendocrine neoplasia: a prospective ENETS CoE analysis
title_full_unstemmed NETest is superior to chromogranin A in neuroendocrine neoplasia: a prospective ENETS CoE analysis
title_short NETest is superior to chromogranin A in neuroendocrine neoplasia: a prospective ENETS CoE analysis
title_sort netest is superior to chromogranin a in neuroendocrine neoplasia: a prospective enets coe analysis
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923057/
https://www.ncbi.nlm.nih.gov/pubmed/33289691
http://dx.doi.org/10.1530/EC-20-0417
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