- More than 15,000 new cases of follicular lymphoma are diagnosed each year in the US, and about 20 percent of patients will relapse within two years1, with few treatment options
- The new cobas test is a companion diagnostic that detects mutations in the EZH2 gene in follicular lymphoma patients who may be eligible for targeted treatment
- Test results can be available in less than a day, aiding clinicians in making timely decisions for effective treatment options that have the potential to prolong patient lives
Roche announces U.S. Food and Drug Administration (FDA) approval of the cobas® EZH2 Mutation Test as a companion diagnostic for TAZVERIK™ (tazemetostat), developed by Epizyme, Inc. This molecular test detects abnormalities in the EZH2, or Enhancer of Zeste Homolog 2 gene, in patients with follicular lymphoma (FL), a type of non-Hodgkin lymphoma patients who may be eligible for treatment with TAZVERIK, a cancer drug that acts as a selective EZH2 gene inhibitor.
In a clinical trial, patients diagnosed with relapsed/refractory FL who tested positive for defined mutations of the EZH2 gene, treatment with TAZVERIK showed significant benefit2.
The approval of the cobas EZH2 Mutation Test underscores Roche’s personalised healthcare strategy to provide innovative diagnostic tools for physicians and their patients,
said John Palma, Chief Medical Officer of Roche Sequencing Solutions.
There have been few treatment options for patients with relapsed follicular lymphoma, and we are pleased to provide clinicians and their patients rapid and reliable results to help determine the best treatment options.
Test samples are processed using the cobas® DNA Sample Preparation Kit for DNA extraction from formalin-fixed paraffin-embedded (FFPE) human FL tumour tissue and the cobas z 480 Analyzer for automated amplification and detection. Results can be available in less than a day.