The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with advanced solid cancers.

The Guardant360 CDx test was also granted approval as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda® (pembrolizumab) and patients with MSI-High advanced colorectal cancer (CRC) who may benefit from Opdivo®  (nivolumab).

This regulatory approval has taken on an added significance as CRC is the most commonly diagnosed cancer in Japan. Guardant360 CDx is offered by Guardant Health Japan, a precision oncology company based in Tokyo which is a wholly owned subsidiary of Guardant Health Asia, Middle East & Africa (AMEA).

Additionally, in December 2021, MHLW granted regulatory approval of the Guardant360 CDx liquid biopsy test as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from treatment with LUMAKRAS™ (sotorasib), a KRAS G12C inhibitor developed and manufactured by Amgen.