NEW YORK — Guardant Health said on Monday that it has received Japanese regulatory approval for its Guardant360 CDx liquid biopsy test for tumor mutation profiling.
According to Guardant, the test was also approved by Japan's Ministry of Health, Labor, and Welfare as a companion diagnostic for patients with microsatellite instability-high, or MSI-high, solid tumors who may benefit from Merck's Keytruda (pembrolizumab) and patients with MSI-high advanced colorectal cancer who may benefit from Bristol Myers Squibb's Opdivo (nivolumab).
Redwood City, California-based Guardant noted that in December, the MHLW also granted regulatory approval for Guardant360 CDx as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer who may benefit from Amgen's KRAS G12C inhibitor Lumakras (sotorasib).
"We strongly believe that our liquid biopsy test will help to enhance the quality of cancer management in Japan by offering tumor mutation profiling and companion diagnostics for therapies in patients whose tumors have KRAS G12C or MSI-high status," Simranjit Singh, CEO of Guardant Health subsidiary Guardant Health Asia, Middle East, and Africa and representative director of the company's Japanese subsidiary Guardant Health Japan, said in a statement.
In mid-2021, the US Food and Drug Administration approved Guardant360 CDx as a companion diagnostic for Lumakras.