Clinical laboratory validation of the MCL35 assay for molecular risk stratification of mantle cell lymphoma.
Gene expression profiling
Ki67
Mantle cell lymphoma
Prognosis
Journal
Journal of hematopathology
ISSN: 1868-9256
Titre abrégé: J Hematop
Pays: Germany
ID NLM: 101491976
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
24
08
2020
accepted:
29
09
2020
entrez:
16
11
2020
pubmed:
17
11
2020
medline:
17
11
2020
Statut:
epublish
Résumé
Mantle cell lymphoma (MCL) is a clinically heterogeneous B cell malignancy for which a variety of prognostic factors have been proposed. Previously, a digital gene expression profiling "proliferation signature" capable of risk stratifying MCL was identified and subsequently developed into a multi-analyte prognostic assay, known as the "MCL35" assay. In this study, we sought to explore the performance characteristics of the MCL35 assay in a clinical laboratory and compare results with the Ki67 proliferation marker. The results describe the clinical validation of the MCL35 assay for molecular risk stratification of MCL including accuracy, sensitivity, specificity, use in acid-decalcified bone marrow core biopsies, fixatives, lower limit of RNA input, quality metrics, and other laboratory parameters. The resulting data indicate that this is a robust technique with outstanding reproducibility. Overall, the data support the concept of molecular signatures, as assessed with digital gene expression profiling, for improved standardization and reproducibility for proliferation assessment in MCL.
Identifiants
pubmed: 33193905
doi: 10.1007/s12308-020-00418-4
pii: 418
pmc: PMC7661397
doi:
Types de publication
Journal Article
Langues
eng
Pagination
231-238Subventions
Organisme : NCI NIH HHS
ID : UH3 CA217847
Pays : United States
Informations de copyright
© The Author(s) 2020.
Déclaration de conflit d'intérêts
Conflict of interestDr. Rimsza is a one of several co-inventors of a patent of the MCL35 assay used in this project.
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