Last year, AmoyDx’s EGFR diagnostic was approved for use in the EU.
January 26, 2018 -- Amoy Diagnostics of Xiamen received CFDA approval for its plasma-based EGFR test. The Super-ARMS® EGFR Mutation Test is a companion diagnostic for EGFR-based inhibitors such as Iressa and Tarceva. The test, the first plasma-based EGFR diagnostic available in China, is indicated for use when a tumor biopsy for a patient is not available. Last year, AmoyDx’s EGFR diagnostic was approved for use in the EU.