The cobas® EZH2 Mutation Test is a real-time, allele-specific polymerase chain reaction (PCR) test for the qualitative detection of single nucleotide mutations of the Enhancer of zeste homolog 2 (EZH2) gene in DNA extracted from formalin-fixed paraffin embedded (FFPE) human follicular lymphoma (FL) tumor tissue. It is intended for the identification of FL patients with an EZH2 mutation for treatment with TAZVERIK™ (tazemetostat), an EZH2 inhibitor.
The test uses primers that define specific base-pair sequences designed to detect the following mutations in Exons 16 and 18: Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V. Additionally, the test uses a wild type region of Exon 11 for robust internal control. Specimens are processed using the cobas® DNA Sample Preparation Kit1 to extract DNA from FFPE tissue. Mutation detection is achieved through PCR analysis with the cobas z 480 Analyzer for automated amplification and detection.
*>24 samples will require 2 kits