Clinical laboratory validation of the MCL35 assay for molecular risk stratification of mantle cell lymphoma
| Autor: | Allison C. Rosenthal, Andrew L. Feldman, Lisa M. Rimsza, Ryan S. Robetorye, Alanna Maguire, Sergei Syrbu, Colleen Ramsower |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Histology Pathology and Forensic Medicine 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Proliferation Marker B cell malignancy Hematology Mantle cell lymphoma business.industry medicine.disease Prognosis Gene expression profiling medicine.anatomical_structure 030220 oncology & carcinogenesis Risk stratification Cancer research Original Article Bone marrow business Core biopsy Ki67 030215 immunology |
| Zdroj: | Journal of Hematopathology |
| ISSN: | 1865-5785 1868-9256 |
| Popis: | 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. Electronic supplementary material The online version of this article (10.1007/s12308-020-00418-4) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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