Roche Diagnostic New Generation Cobas EGFR mutation Detection is approved for listing in China

  • 2018-09-19
Recently, Roche Diagnostics, a global leader in in vitro diagnostics, announced that its new generation of cobas EGFR Mutation Test v2 has been officially commercialized in China. The test has been approved by the China Food and Drug Administration for the detection of epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer (NSCLC) tumor tissue samples, and the indications for plasma samples are under registration.
Cobas EGFR Mutation Test v2 is the first and only current tumor test approved by the Food and Drug Administration (FDA) to be adopted in both tissue and plasma as a sample. The technology brings new hope to patients who cannot provide tumor samples for EGFR testing. The test has been adopted and validated by several large international multi-center registered clinical studies (e.g. ENSURE, AURA2, AURA3, FLAURA, etc.) and non-registered clinical studies (e.g. FASTACT2, Aarhus Study, ASPIRATION, AURA, etc.). Cobas EGFR Mutation Test v2 is a real-time PCR assay that allows tissue or plasma sample testing to be performed only with one single kit.
EGFR mutation detection can assist in screening patients with NSCLC who are eligible for TKI therapy. Cobas EGFR Mutation Test v2 can detect 42 gene mutations in exon 18-21, including L858R, exon 19 deletion, L861Q and other TKI-sensitive mutations, and TKI resistance mutations including T790M, which is superior to any other in vitro diagnostic tests in the market. Its unique detection site scan help identify more patients who can benefit from targeted therapy. In April and August of this year, cobas EGFR Mutation Test v2 has been approved by FDA for use in the first-line accompanying diagnosis of the targeted drugs TAGRISSO and IRESSA.