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AmoyDx Pan Lung Cancer PCR Panel Approved as Companion Diagnostic for Repotrectinib in Advanced NSCLC

NextEdge Admin

25 Sep 2024

1 min 27 sec

Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd. (AmoyDx), and Precision Medicine Asia Co., Ltd. (PREMIA) have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel as a companion diagnostic (CDx) for AUGTYRO® (repotrectinib). This approval is for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) harboring the ROS1 fusion gene. AUGTYRO®, developed by Bristol-Myers Squibb K.K., will be available in a 40 mg capsule.

The AmoyDx PLC Panel utilizes advanced PCR technology to detect alterations in 11 key driver genes and identifies actionable mutations in seven genes, enabling tailored treatment options for NSCLC. This approval marks a significant advancement in precision oncology, enhancing treatment selection and improving outcomes for patients. "The AmoyDx PLC Panel expands therapeutic options for advanced NSCLC patients with ROS1 fusion," said Kenji Iwakabe, CEO of Riken Genesis.