Guardant Health has received three new approvals from the Japanese Ministry of Health, Labor, and Welfare (MHLW) for its Guardant360 CDx liquid biopsy test.
The MHLW has cleared Guardant360 CDx for mutation profiling in patients with advanced solid tumors. In addition, it approved Guardant360 CDx as a companion diagnostic for identifying patients with microsatellite instability-high solid tumors who may benefit from pembrolizumab (Keytruda). What's more, Guardant360 CDx has also been approved for patients with MSI-High advanced colorectal cancer who may benefit from nivolumab (Opdivo).
The new approvals follow the MHLW's December 2021 clearance of Guardant360 CDx as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer who may benefit from being treated with sotorasib (Lumakras).