The Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumour 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 tumours 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.

"We are delighted to receive regulatory approval in Japan for the Guardant360 CDx test. We strongly believe that our liquid biopsy test will help to enhance the quality of cancer management in Japan by offering tumour mutation profiling and companion diagnostics for therapies in patients whose tumours have KRAS G12C or MSI-High status. One of the key benefits of our liquid biopsy test is that it enables physicians to match patients to appropriate treatment quickly without the complications and delays of a tissue biopsy," said Simranjit Singh, Chief Executive Officer of Guardant Health AMEA and Representative Director of Guardant Health Japan.

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