• Largest study to date evaluating MRD detection using tissue-free approach demonstrates 81% longitudinal sensitivity for recurrence in stage II or higher colon cancer
• Data demonstrate potential clinical utility of ctDNA as tool to improve management of stage II and higher CRC that allows for rapid evaluation without complexity of prior tissue analysis

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced Clinical Cancer Research, a journal of the American Association for Cancer Research, will publish results today from the COSMOS study confirming the high sensitivity and specificity of the Guardant Reveal blood test in predicting recurrence of colorectal cancer (CRC).

The COSMOS (COnquer Solid Malignancies by blOod Screening) study is the largest study to date evaluating minimal residual disease (MRD) detection using a tissue-free epigenomic approach with the Guardant Reveal test.¹ The study assessed more than 1,900 longitudinal surveillance samples from 342 patients with clinical stage I-III resected CRC.² The study results demonstrated that detection of MRD using the Guardant Reveal test was associated with statistically significant and clinically relevant recurrence prediction at each post-surgical timepoint evaluated for patients with stage II or higher CRC.

“In the COSMOS study, we observed sensitive and specific detection of minimal residual disease in resected colorectal cancer using the Guardant Reveal tissue-agnostic epigenomic-based ctDNA assay,” said Yoshiaki Nakamura, M.D., Ph.D., chief, International Research Promotion Office, Department of Gastroenterology and Gastrointestinal Oncology at National Cancer Hospital East in Chiba, Japan, and a co-lead author of the study. “The use of a tissue-free assay offers healthcare systems significant logistical advantages by reducing the burden of tissue handling, as well as a shorter initial turnaround time for the result during the adjuvant decision-making window, while maintaining overall longitudinal performance comparable to previously reported tissue-informed approaches.”

Key study findings include:

• 100% of patients were able to undergo evaluation without the need for tissue testing
• 98% specificity in samples from patients without recurrence
• 81% longitudinal sensitivity for recurrence in stage II or higher colon cancer
• 5.3-month median lead time from ctDNA detection to recurrence

“Studies have established an association between the presence of residual disease after surgery and a higher probability of recurrence in early-stage colon cancer,” said Craig Eagle, M.D., Guardant Health chief medical officer. “The COSMOS study provides strong support for the use of the Guardant Reveal test to help inform adjuvant therapy decisions for patients with stage II or III colon cancer and, in post-treatment surveillance, to detect recurrence earlier than standard of care.”

The study will be published at 10:00 am EDT on August 7 in Clinical Cancer Research.

About Guardant Reveal

The first tissue-free test for minimal residual disease (MRD) detection in colorectal cancer, Guardant Reveal is also available for breast and lung cancers. Requiring only a simple blood draw, the test interrogates thousands of epigenomic signals to precisely quantify tumor fraction, offering sensitive and specific MRD results in under 10 days to inform timely clinical decisions in the post-surgery and surveillance settings in early-stage cancer. Guardant Reveal is a Laboratory Developed Test (LDT) with performance characteristics determined by the Guardant Health clinical laboratory in Redwood City, California, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. This test has not been reviewed or approved by the U.S. Food and Drug Administration (FDA).

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.

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, 2023, and any current and periodic 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. Nakamura Y, Tsukada Y, Matsuhashi N, et al. Colorectal cancer recurrence prediction using a tissue-free epigenomic minimal residual disease assay. Clin Cancer Res 2024. doi: 10.1158/1078-0432.CCR-24-1651. In press.

2. Samples were collected at day 28 and every 3 to 6 months post-operatively for up to five years or until clinical recurrence.

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