gefitinib
Roche EGFR Mutation Test Approved by FDA as Companion Diagnostic for NSCLC
Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
Foundation Medicine Liquid Biopsy Gets FDA Approval for Multiple Companion Diagnostic Indications
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
China's NMPA Extends Approval for Roche Cobas EGFR Mutation Test v2 to Plasma Samples
Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.
FDA Approves Roche Cobas EGFR Mutation Test as CDx for Iressa
The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).