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

Journal of Hematopathology
Colleen A RamsowerLisa M Rimsza

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.

References

Oct 27, 2007·Blood·Eva HosterUNKNOWN European Mantle Cell Lymphoma Network
Aug 12, 2009·Journal of Hematopathology·Wolfram KlapperUNKNOWN European MCL Network
Apr 2, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eva HosterMichael Unterhalt
Mar 16, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David W ScottUNKNOWN Lymphoma/Leukemia Molecular Profiling Project
Aug 11, 2018·British Journal of Haematology·Hilka Rauert-WunderlichAndreas Rosenwald
Jan 25, 2020·Virchows Archiv : an International Journal of Pathology·Giorgio A CrociWolfram Klapper
Aug 3, 2020·Critical Reviews in Oncology/hematology·Sergio CortelazzoMartin Dreyling

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