Roche Diagnostics' cobas EGFR Mutation Test v2 Plasma Assay Receives NMPA Approval in China

Jul 03, 2019 12:35 CST Updated 12:35

Roche

Oncology Drug Research, Development, and Manufacturing

Recently, Roche Diagnostics, a global leader in in vitro diagnostics, announced that its next-generation cobas^®EGFR Mutation Testing (cobas^®EGFR Mutation Test v2) The indication for plasma samples has also been officially approved in China.

cobas^®EGFR Mutation Test v2 is the first and currently the only tumor genetic test approved by the U.S. Food and Drug Administration (FDA) for use with both tissue and plasma samples. The approval of the plasma-based assay offers new hope for patients who are unable to provide tumor tissue samples for EGFR mutation testing.

01	Broadest Site Coverage:Covers 42 gene mutations in exons 18–21, including exon 19 deletions, L858R, L861Q, and T790M mutations.
02	Clear Companion Diagnostics:The only NMPA-approved targeted drug, Tarceva^®（Tarceva^®), Tagrisso^®（TAGRISSO^®) and Iressa^®（IRESSA^®) first-line companion diagnostics
03	Objective Efficacy Assessment:Included in multiple large-scale international multicenter clinical studies, such as ENSURE, AURA, AURA2, AURA3, FLAURA, FASTACT-2, Aarhus, and ASPIRATIONAdopted and validated by et al.
04	Semi-quantitative Monitoring Only:The only one approved for measuring changes in target mutant cfDNA in patients over a period of time
05	Plasma and Tissue Highly Correlated:The concordance rates for the detection of exon 19 deletions, L858R, and T790M were 93.7%, 92.6%, and 65.9%, respectively.