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Amoy Diagnostics, Amgen Partner on Lung Cancer CDx Development for Lumakras in Japan

NEW YORK – Amoy Diagnostics and Amgen on Thursday said that they have entered a strategic partnership to develop a companion diagnostic for the Japanese market to identify non-small cell lung cancer patients for Amgen's KRAS G12C inhibitor, sotorasib (Lumakras).

Specifically, Xiamen, China-based AmoyDx will develop its PCR-based test to screen NSCLC patients for sotorasib eligibility. The test, dubbed AmoyDx Pan Lung Cancer PCR Panel, or AmoyDx PLC Panel, received approval from Japanese regulators in June, at which time it was cleared for CDx use evaluating four lung cancer driver genes associated with nine targeted therapies.

In total, AmoyDx's test is capable of screening patients for mutations in 11 driver genes — EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3. Since 2019, the test has also been used as a tool for screening patients for targeted therapy clinical trials in Japan as part of the Lung Cancer Genomic Screening Project for Individualized Medicine, or LC-SCRUM.

In the US, Amgen's sotorasib received US Food and Drug Administration approval in May, at which time the agency also approved two companion diagnostics to identify patients with the KRAS G12C mutation: Qiagen's Therascreen KRAS RGQ PCR kit and Guardant Health's Guardant360 CDx.