Guardant360® Tissue Receives MOHW LDTS approval in Taiwan

Approval paves the way for possible reimbursement coverage in future

TAIPEI, Nov. 11, 2026 /PRNewswire/ -- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that the Guardant360^® Tissue test has received Laboratory Developed Tests and Services (LDTS) approval from the Ministry of Health and Welfare (MOHW). With this approval, the test has a pathway to reimbursement coverage, and copayment of the test will be made available progressively across major hospitals in Taiwan.

"Taiwan's LDTS approval for Guardant360 Tissue expands patient access to comprehensive tumor profiling as part of an evolving precision oncology strategy. The approval complements the Guardant360 test, which received LDTS approval from MOHW in 2024. Guardant360 Tissue is the first approved test in Taiwan that includes both genomic and epigenomic insights. This gives clinicians a complete picture of cancer and more flexible testing options for improved clinical decision-making and patient care outcomes," said Simranjit Singh, Chief Executive Officer, Guardant Health AMEA.

Guardant360 Tissue analyzes 740+ DNA genes and 367 RNA genes, plus tumor mutational burden, microsatellite instability status and methylation-based features. It provides comprehensive genomic profiling for patients with advanced solid tumors, making it a guideline-complete panel across all advanced solid tumors^‡.

Guardant360 Tissue requires 40% fewer slides^#, 92% less tissue surface area^§ and 75% less tumor cellularity^¶ – the lowest sample requirements in the industry, allowing oncologists to test more patients with less tissue. The test enables insights beyond what can typically be found using tests that do not incorporate comprehensive analysis of epigenetics. These insights can apply to important classes of therapeutics, such as PARP-inhibitors and immunotherapies.

Guardant360 Tissue also enables classification and subtyping of each individual tumor at a much higher resolution and is powered by InfinityAI – Guardant's proprietary platform that harnesses a large real-world data set^†† to generate actionable AI-powered insights across the continuum of care.

Cancer is the leading cause of death in Taiwan, accounting for over 25% of all deaths in 2023^[1]. Lung, colorectal and breast cancers recorded the highest incidence, driven by population aging and lifestyle changes.

 

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health Forward-Looking Statements

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, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. 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.

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SOURCE Guardant Health, Inc.