Guardant Health Receives Regulatory Approval for Guardant360 CDx in Japan


Guardant Health, Inc., a leading precision oncology company, announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Guardant360® CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling, in patients with advanced solid tumors.

MHLW also approved Guardant360 CDx 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). In December 2021, MHLW granted regulatory approval of Guardant360 CDx as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from treatment with LUMAKRAS™ (sotorasib).

“The MHLW approval of Guardant360 CDx marks a significant milestone for Guardant Health and further reinforces the value blood-based testing brings to physicians and patients with advanced cancer. With a simple blood draw, a physician can conduct comprehensive genomic profiling of a patient’s tumor, then match that patient with the best available treatment option without the complications and delays of a tissue biopsy,” said Helmy Eltoukhy, Guardant Health co-CEO. “Today’s approval further strengthens Guardant Health’s global commitment to transform cancer care by bringing innovative blood-based tests like Guardant360 CDx to physicians and advanced cancer patients in Japan.”

About Guardant360 CDx

Guardant360 CDx is a liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from the blood samples of patients with advanced solid tumors and identifies genetic alterations that may inform treatment decisions. On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360CDx for comprehensive genomic profiling across all solid cancers and as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso® (osimertinib). This approval represented the first FDA-approved liquid biopsy test for comprehensive tumor mutation profiling across all solid cancers.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360® CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. These tests fuel development of its screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.