NEW YORK (GenomeWeb) – The China Food and Drug Administration has approved Amoy Diagnostics' SuperARMS EGFR mutation analysis test as a companion diagnostic for EGFR TKI-based non-small cell lung cancer drugs, the company said today.
According to Xiamen, 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 test was CE-IVD marked in April.
"The development of liquid biopsy-based diagnostics in non-small cell lung cancer will transform the diagnostic workup of advanced-stage patients," Guangdong General Hospital Vice President Yi-long Wu said in a statement. "The ability to both isolate and genetically interrogate tumor DNA from a simple, minimally invasive test that can subsequently inform treatment decisions will benefit [both] ... 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.