Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a Chinese diagnostics company, has announced that it has received two new indication approvals in Japan for its APACE (also known as PCR-11 gene product), a multi-target rapid screening product designed for lung cancer detection. The product is now approved as a companion diagnostic (CDx) for Novartis’s Tabrecta (capmatinib) and Haihe Pharma’s glumetinib, both of which are MET-targeted tyrosine kinase inhibitors (TKIs). This approval will facilitate the precise treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor a MET exon 14 jump mutation.
APACE, the first approved tumor multi-gene joint detection PCR product in Japan, offers a streamlined approach to mandatory gene testing, providing accurate results with a high success rate and good stability. The product requires a small sample size and offers fast reporting, making it a valuable tool in the diagnostic landscape. The Japanese Ministry of Health, Labour and Welfare has approved APACE for seven targets, including EGFR, ALK, ROS1, BRAF, MET, KRAS G12C, and RET, enabling the clinical application of 16 related targeted drugs for NSCLC.- Flcube.com
