AmoyDx wins Chinese approval for Liquid Biopsy
The China Food and Drug Administration (CFDA) has approved Amoy Diagnostics’ SuperARMS EGFR mutation analysis test as a companion diagnostic for EGFR TKI-based non-small cell lung cancer drugs. China-based AmoyDx, the real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples from patients with advanced or metastatic NSCLC. The development of liquid biopsy-based diagnostics in non-small cell lung cancer is intended to transform the diagnostic workup of advanced-stage patients. The ability to both isolate and genetically interrogate tumor DNA from a simple, minimally invasive test that can subsequently inform treatment decisions will benefit boththe physician and patient. In 2016, AmoyDx partnered with Merck KGaA to develop a SuperARMS-based liquid biopsy test for metastatic colorectal cancer for the Chinese market.