Guardant Health announces reimbursement approval of Guardant360® CDx liquid biopsy test in Japan

Rhea-AI Summary

Guardant Health has received national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare for its Guardant360 CDx liquid biopsy test for comprehensive genomic profiling. The test analyzes circulating tumor DNA to provide genomic profiling for all solid tumor cancers. This approval represents a significant milestone for the company as Japan is the first country in the Asia-Pacific region to reimburse the use of the test.

Positive

• Guardant Health has received national reimbursement approval in Japan for its Guardant360 CDx test, expanding access to comprehensive genomic profiling for advanced cancer patients. This approval opens up new market opportunities for the company and could positively impact its stock price.

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Reimbursement supports expanded access to blood-based comprehensive genomic profiling with Guardant360 CDx for patients with advanced solid tumor cancers and their care teams across Japan

PALO ALTO, Calif.--(BUSINESS WIRE)-- 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.

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 GuardantINFINITY™ tests for advanced-stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.

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, 2023. https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf

View source version on businesswire.com: https://www.businesswire.com/news/home/20230705875197/en/

Investor Contact:

Alex Kleban

investors@guardanthealth.com

+1 657-254-5417

Media Contact:

Breen Weir

press@guardanthealth.com

+1 843-384-0095

Source: Guardant Health, Inc.

FAQ

What is the Guardant360 CDx test?

The Guardant360 CDx test is a liquid biopsy test that analyzes circulating tumor DNA to provide comprehensive genomic profiling for all solid tumor cancers.

What is the significance of the national reimbursement approval in Japan?

The national reimbursement approval in Japan allows for expanded access to the Guardant360 CDx test, which could lead to increased adoption and market opportunities for Guardant Health.

How many tests have been ordered to date?

Over 400,000 tests have been ordered to date for the Guardant360 CDx test.

What are the most prevalent cancer types in Japan?

The most prevalent cancer types in Japan are lung, stomach, prostate, colon, and breast cancers.

What other regulatory approvals has the Guardant360 CDx test received?

The Guardant360 CDx test has received regulatory approvals as a companion diagnostic for identifying patients with microsatellite instability-high (MSI-High) solid tumors, metastatic non-small cell lung cancer (NSCLC), and advanced colorectal cancer (CRC).