- Lung cancer causes more than 1.7 million deaths worldwide each year, with NSCLC accounting for about 85 percent of all cases
- The cobas EGFR Mutation Test v2 is FDA approved as a companion diagnostic for the detection of EGFR mutations in NSCLC for both tissue and plasma samples, with results available in less than eight hours
- The new FDA approval allows the test to be used as a companion diagnostic for a broad group of EGFR TKI therapies
PLEASANTON, California, Oct. 29, 2020 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of expanded claims for the cobas® EGFR Mutation Test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of non-small cell lung cancer (NSCLC). This claim expansion allows the test to be used as a CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordance with the approved therapeutic product labeling. The group claim will also enable the test to be used as a CDx for any future approved EGFR TKI therapies targeting the same mutations, without the need to conduct individual clinical studies with the test for each new therapy.
"Clinicians can now have greater confidence in the robustness, reliability and proven clinical utility of the cobas EGFR Mutation Test v2 when evaluating lung cancer patients who may benefit from targeted EGFR TKI therapies," said Neil Gunn, Head of Roche Sequencing Solutions. "By approving a single test for a broad group of therapies, this new and innovative approach by the FDA can pave the way for future EGFR TKI therapies to utilise the cobas EGFR Mutation Test v2 to help identify patients for personalised medicine."
About the cobas EGFR Mutation Test v2
The cobas EGFR Mutation Test v2 is a real-time polymerase chain reaction (PCR) test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating tumour DNA (ctDNA) from plasma derived from ethylenediamine tetraacetic acid (EDTA) anti-coagulated peripheral whole blood.
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- WHO IARC Globocan in 2018 Cancer Facts & Figures, 2018
- cobas EGFR Mutation Test v2 package insert
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-labeling-vitro-companion-diagnostic-devices-specific-group-oncology-therapeutic 10 August 2020
Roche Molecular Solutions Media Relations