Guardant360 CDx submitted for regulatory approval in Japan

A comprehensive genomic profiling test utilizing blood samples from patients with advanced solid tumors

TOKYO, Feb. 3, 2021 /PRNewswire/ -- Guardant Health Japan, an affiliate of Guardant Health Asia, Middle East & Africa (AMEA) has announced that it has submitted its application to the Ministry of Health, Labour and Welfare (MHLW) for regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling (CGP) in patients with advanced solid cancerous tumors.

"I am delighted to announce that we have submitted the regulatory application for Guardant360 CDx liquid biopsy test for approval by MHLW. Several clinical studies1,2 have shown that compared to invasive tissue-based testing, Guardant360 has a quicker turnaround time for reporting comprehensive genomic test results. For the patient, this means a shorter waiting time to get the most appropriate treatment while avoiding safety risks related to tissue biopsies. We are excited to make this a possibility in clinical practice for cancer patients in Japan," said Simranjit Singh, Chief Executive Officer of Guardant Health AMEA & Representative Director of Guardant Health Japan.

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. In addition to the submission of Guardant360 CDx for tumor mutation profiling, Guardant Health Japan has simultaneously filed for a Companion Diagnostic (CDx) approval. On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360®CDx 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.

Guardant Health Japan aims to contribute to precision oncology in Japan by supporting research and development efforts and drive broad clinical adoption of Guardant Health's products.

About Guardant Health Japan

Guardant Health Japan is an affiliate of Guardant Health AMEA, Inc., a joint venture between SoftBank and Guardant Health, Inc., a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.


1. Leighl NB, Page RD, Raymond, VM, et al. Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer, Clin Cancer Res. doi: 10.1158/1078-0432.CCR-19-0624.

2. Nakamura, Y., Taniguchi, H., Ikeda, M. et al. Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies. Nat Medicine (2020).