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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.

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.

Results from the CheckMate-227 trial provided evidence for the use of nivolumab and ipilimumab in combination, while the FLAURA study focused on osimertinib.

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.

Instead of trying to tackle resistance by targeting rare mutations, researchers are looking to antibody based therapies that are more broadly active in lung cancer patients.

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).

The study combined large-scale protein post-translational modification datasets with protein-protein interaction data to profile cell signaling in lung cancer.

The Institute for Clinical and Economic Review is seeking public comment on its plan to evaluate the cost-effectiveness of EGFR inhibitors and immunotherapies.

Non-small cell lung cancer patients with EGFR mutations now have three treatment choices, and AstraZeneca is working on newer personalized treatment options.

The test was approved for use with Iressa to determine those patients who would benefit by being treated with the drug.