Clinical laboratory validation of the MCL35 assay for molecular risk stratification of mantle cell lymphoma

Colleen A. Ramsower, Alanna Maguire, Ryan S Robetorye, Andrew L. Feldman, Sergei I. Syrbu, Allison C. Rosenthal, Lisa M. Rimsza

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)231-238
Number of pages8
JournalJournal of Hematopathology
Volume13
Issue number4
DOIs
StatePublished - Dec 2020

Keywords

  • Gene expression profiling
  • Ki67
  • Mantle cell lymphoma
  • Prognosis

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Histology
  • Hematology

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