CFDA approves EGFR TKI companion diagnostic

Amoy Diagnostics Co. Ltd. (SZSE:300685) said China FDA approved the Super-ARMS EGFR Mutation Test as a companion diagnostic for EGFR tyrosine kinase inhibitor (TKI) therapies, including Iressa gefitinib and Tagrisso osimertinib from AstraZeneca plc (LSE:AZN; NYSE:AZN); Tarceva erlotinib from Astellas Pharma Inc. (Tokyo:4503); and Gilotrif afatinib from Boehringer Ingelheim GmbH (Ingelheim, Germany). The company says it is the first companion diagnostic approved by the CFDA to detect EGFR gene mutations in circulating tumor DNA derived from plasma...