Guardant Health Receives Regulatory Approval for Guardant360 CDx in Japan

TOKYO,March 14,2022 -- The 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 (CGP),in patients with advanced solid cancers. The Guardant360 CDx test was also granted approval 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). This regulatory approval has taken on an added significance as CRC is the most commonly diagnosed cancer in Japan1. Guardant360 CDx is offered by Guardant Health Japan,a precision oncology company based in Tokyo which is a wholly owned subsidiary of Guardant Health Asia,Middle East & Africa (AMEA).

Additionally,in December 2021,MHLW granted regulatory approval of the Guardant360 CDx liquid biopsy test as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from treatment with LUMAKRAS™ (sotorasib),a KRAS G12C inhibitor developed and manufactured by Amgen.

"We are delighted to receive regulatory approval in Japan for the Guardant360 CDx test. 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. One of the key benefits of our liquid biopsy test is that it enables physicians to match patients to appropriate treatment quickly without the complications and delays of a tissue biopsy," said Simranjit Singh,Chief Executive Officer of Guardant Health AMEA and Representative Director of Guardant Health Japan.

"Guardant Health Japan is dedicated to bringing innovative and comprehensive liquid biopsy tests such as Guardant360 CDx to Japan so that patients with advanced stage cancer can benefit from genomic profiling information. This regulatory approval has been made possible because of the collaborations we have with leading cancer experts in Japan. We are strongly committed to serving Japanese patients and physicians,and this is the first of many products in the Guardant portfolio which we plan to roll out in the near future," said Gen Asano,General Manager of Guardant Health Japan.

With just a simple blood draw from the patient,the Guardant360 CDx test helps guide treatment decisions for patients with advanced stage cancer. Having secured this regulatory approval,Guardant Health Japan aims to drive clinical adoption of liquid biopsy testing in Japan and enable more patients to receive potentially life-changing precision medicines.

About Guardant Health Japan

Guardant Health Japan is a wholly owned subsidiary of Guardant Health AMEA,Inc.,a joint venture between SoftBank and Guardant Health,a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests,vast data sets and advanced analytics. The Guardant Health oncology platform is designed to leverage its capabilities in technology,clinical development,regulatory and reimbursement to drive commercial adoption,improve patient clinical outcomes and lower healthcare costs. Visit us online at https://guardanthealthjapan.com.

About Guardant360® CDx

Guardant360® CDx is Guardant Health's comprehensive liquid biopsy test which helps guide treatment decisions for patients with advanced stage cancer. It is a leading next generation sequencing test in the U.S. that analyzes circulating tumor DNA (ctDNA). ctDNA is produced when tumors shed small pieces of their genetic material into the bloodstream. Traces of this ctDNA can be detected in the blood using digital sequencing technology. Guardant360 CDx was the first liquid biopsy to receive approval from the U.S. Food and Drug Administration (FDA) in August 2020 for comprehensive tumor mutation profiling across all solid cancers.Reference1. GLOBOCAN 2020 statistics available at https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdfaccessed on 17 February 2022