Clinical Performance of the Idylla MSI Test for a Rapid Assessment of the DNA Microsatellite Status in Human Colorectal Cancer.
Adolescent
Adult
Aged
Aged, 80 and over
Biomarkers, Tumor
Colorectal Neoplasms
/ diagnosis
Female
Genetic Testing
/ methods
Humans
Immunohistochemistry
Male
Microsatellite Instability
Microsatellite Repeats
Middle Aged
Necrosis
/ pathology
Neoplasm Staging
Reproducibility of Results
Sensitivity and Specificity
Young Adult
Journal
The Journal of molecular diagnostics : JMD
ISSN: 1943-7811
Titre abrégé: J Mol Diagn
Pays: United States
ID NLM: 100893612
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
05
04
2019
revised:
06
11
2019
accepted:
05
12
2019
pubmed:
28
12
2019
medline:
13
5
2021
entrez:
28
12
2019
Statut:
ppublish
Résumé
In this study, the clinical performance of the Idylla MSI test (investigational use only) was evaluated in 330 colorectal carcinoma samples (all stages). This test is fully automated, from formalin-fixed, paraffin-embedded slide to result, and gives a result in <2.5 hours. Compared with the Promega MSI Analysis System version 1.2, an overall agreement, sensitivity, and specificity of 99.7%, 98.7%, and 100%, respectively, was reached. Whereas seven samples were invalid with the Promega MSI Analysis System, only two were invalid with the Idylla MSI test. Compared with the historical immunohistochemistry (IHC) data, overall agreement, sensitivity, and specificity of 98.7%, 94.4%, and 100%, respectively, were observed. Tumor mutation burden analysis of the discordant IHC cases was in favor of the Idylla MSI test result in three of the four samples. Furthermore, for those cases where the IHC data were invalid or hard to interpret because sole loss of one DNA mismatch repair deficiency marker was observed, Idylla MSI test results were always valid and accurate. Herein, the Idylla MSI test has been shown to be an accurate, fast screening assay for the detection of microsatellite status in colorectal cancer patients, with a low number of invalid results.
Identifiants
pubmed: 31881332
pii: S1525-1578(19)30458-1
doi: 10.1016/j.jmoldx.2019.12.002
pii:
doi:
Substances chimiques
Biomarkers, Tumor
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
386-395Informations de copyright
Copyright © 2020 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.