BioCentury
ARTICLE | Clinical News

Cobas EGFR Mutation Test v2 regulatory update

November 16, 2015 8:00 AM UTC

FDA approved a PMA from Roche for cobas EGFR Mutation Test v2 as a companion diagnostic for Tagrisso osimertinib from AstraZeneca to treat EGFR T790M mutation-positive, metastatic non-small cell lung cancer (NSCLC). Roche and AZ co-developed the in vitro diagnostic test that detects 42 mutations across the EGFR gene, including T790M, under a 2014 deal (see BioCentury Aug. 4, 2014). ...