Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360^® CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers. This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022

There were over one million new cancer cases in Japan in 2020 with lung, stomach, prostate, colon and breast being the most prevalent cancer types.¹ The Guardant360 CDx test analyzes circulating tumor DNA (ctDNA) to provide comprehensive genomic profiling, or tumor mutation profiling, for all solid tumor cancers. It is used by healthcare professionals to detect actionable biomarkers in a patient’s blood that may help inform their therapy selection.

Currently, Guardant360 CDx is approved by the MHLW 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). The MHLW also 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 decision of the MHLW to provide reimbursement for Guardant360 CDx represents a significant milestone for the company as Japan is the first country in the Asia-Pacific region to reimburse the use of our test to support advanced cancer patients,” said Helmy Eltoukhy, co-CEO of Guardant Health. “We are encouraged by the strong support we have received from oncologists in Japan, and we look forward to furthering these partnerships as we continue our commitment to democratize access to precision oncology and bring blood-based comprehensive genomic profiling to patients and care teams across the region.”

The Guardant360 CDx test has achieved U.S. FDA Approval and is CE-Marked for comprehensive genomic profiling across all solid tumor cancers and has become widely accepted for blood-based CGP worldwide. With more than 350 peer-reviewed publications, the test has been trusted by more than 12,000 oncologists with over 400,000 tests ordered to date.