The reimbursement expands access to blood-based comprehensive genomic profiling with Guardant360 CDx for patients with advanced solid tumor cancers and their care teams across Japan.

TOKYO, August 3, 2023 – Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announces it has recently received national reimbursement approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the Guardant360^® CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumors. This approval is effective July 24, 2023, and follows the regulatory approval of the Guardant360 CDx test for CGP by the MHLW in March 2022.

SRL Corporation, which offers clinical laboratory testing, has begun accepting orders for the test.

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 tumors. It is used by healthcare professionals to detect actionable biomarkers from the tumors that are released in the patients’ 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).

“We are very pleased that we can start providing our CGP test Guardant360^® CDx. The test provides meaningful information that can help inform treatment for patients with advanced cancer, particularly when it is difficult to perform tests on solid tumor samples”, said Guardant’s CEO Asia, Middle East and Africa, Mr. Simranjit Singh.

“Our mission is to conquer cancer by making full use of data, and we will do our utmost to make a positive impact on patients and their families as we aim to further advance personalized medicine in cancer treatment through the use of CGP.”

The test offers oncologists and healthcare specialists the opportunity to move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment, informing treatment decisions in patients with advanced-stage disease.

The Guardant360 CDx test was the first blood test to be approved by the U.S. Food and Drug Administration (FDA) for comprehensive genomic profiling for all solid tumors, and it is now FDA approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. Guardant360 CDx is also CE-Marked and approved by Singapore’s HSA for comprehensive genomic profiling for all solid tumors. Since being introduced as a laboratory developed test (LDT), the Guardant360 liquid biopsy has become widely accepted for blood-based CGP with more than 400 peer-reviewed publications.

The approval for reimbursement with the Japanese healthcare system represents a positive step for innovation and precision oncology by the MHLW and will lead to improved treatment and diagnosis for patients.

About Guardant Health Japan
Guardant Health Japan is part of Guardant Health AMEA, a wholly owned subsidiary of 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. 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. For more information, please visit https://www.guardanthealthjapan.com.

About SRL
Since the establishment in 1970, SRL, Inc., a member of H.U. Group Holdings, Inc., Japan-based leading healthcare group, has been providing comprehensive testing services as the largest commercial clinical laboratory in Japan. SRL carries out nearly 400,000,000 tests per year, covering a wide range of testing services including general/emergency testing, esoteric/research testing, companion diagnostics tests, genomic analysis, and etc. For more information, please visit https://www.srl-group.co.jp/english/.

Forward-Looking Statement
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2022, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

References:

1. International Agency for Research on Cancer. Japan. Globocan 2020. Accessed online June 29, 2022. https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf

Media Contact:
Jasmeet (Jasmine) Kaur
Head of Government and Corporate Affairs AMEA
Email: jaskaur@guardanthealth.com
Contact number: +65.9124.9021