cobas® EZH2 Mutation Test

product box for cobas EZH2

A companion diagnostic for patients with follicular lymphoma

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, Y646H, Y646F, Y646S, Y646C, A682G, A692V. Additionally, the test detects a target mutation in 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.

Features and benefits2

  • Single 5 µm tissue section (total DNA input of 150 ng)
  • High concordance with NGS in clinical trial (N=341): >98% (PPA) and >98% (NPA)
  • Reproducibility: 100% agreement in 2,690 valid tests 
  • Analytical sensitivity 1-5% mutation (variant-dependent) 
  • Time to results <8 hours
  • Throughput 1 – 30* samples per run

*>24 samples will require 2 kits

Intended use

Intended use

The cobas® EZH2 Mutation Test is a real-time allele-specific PCR test for qualitative detection of single nucleotide mutations for Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 gene in DNA extracted from formalin fixed paraffin embedded (FFPE) human follicular lymphoma tumor tissue specimens. The cobas® EZH2 Mutation Test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK™ (tazemetostat), in accordance with the approved therapeutic product labeling.

Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 Analyzer for automated amplification and detection.

Registration status

US-IVD

References
 
  1. cobas® DNA Sample Preparation Kit package insert
  2. cobas® EZH2 Mutation Test package insert