Performance of the cobas EZH2 mutation test on clinical samples from non-Hodgkin lymphoma patients.

ABSTRACT:

Objective

To present the technical verification and clinical validation of the companion diagnostic assay, cobas® EZH2 Mutation Test (cobas EZH2 Test), targeting gain-of-function EZH2 mutations in follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). The focus is on patient clinical samples proving that the test met the performance criteria required for FDA approval of a companion diagnostic test.

Design

Epizyme, Inc., Eisai Co., Ltd., and Roche Molecular Systems, Inc., collaborated to develop the cobas EZH2 Test on an RT-PCR platform. The assay design needed to detect the gain-of-function EZH2 mutations found in FL and DLBCL indications. Thus, the test was optimized for investigational purposes in a clinical trial setting. Part of its technical verification in

SUBMITTER: Shyu JY 

PROVIDER: S-EPMC10721068 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature