• COSMOS study shows Guardant Reveal™ blood test highly predictive for disease recurrence in patients with early-stage colon cancer without need for tissue specimen

PALO ALTO, Calif. / Jan 17, 2024 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, will present interim data from the COSMOS study supporting the use of Guardant Reveal to predict disease recurrence in patients with early-stage colon cancer at the ASCO 2024 Gastrointestinal Cancers Symposium, January 18-20 in San Francisco.

Guardant Reveal analyzes comprehensive molecular signals in the blood to detect and quantify minimal residual disease (MRD). The COSMOS study evaluated the use of the newest version of the test, built on the Guardant Infinity™ smart liquid biopsy platform, to identify MRD and predict disease recurrence in 130 patients with early-stage (II and III) colon cancer. Interim data to be shared at ASCO GI suggest the test is both highly specific (low false positives) and predictive for recurrence, without dependence on a tissue sample.

“Studies have established the presence of residual disease after surgery is associated with a higher probability of recurrence in early-stage colon cancer,” said Craig Eagle, M.D., Guardant Health chief medical officer. “The interim COSMOS data are very promising and support the use of Guardant Reveal to predict disease recurrence and help inform adjuvant therapy decisions for patients with Stage II or III colon cancer.”

Guardant and its research partners will also present multiple posters at the symposium highlighting the application of Guardant technology in blood-based screening and in identifying potentially targetable mutations in GI cancers, including predictive markers for treatment resistance.

Guardant Health 2024 ASCO GI Poster Presentations

Guardant Reveal

• Multiomic Analysis for Minimal Residual Disease Detection: Addressing Challenges in Stage II-III Colon Cancer from COSMOS-CRC-01 (Abstract 180 | Poster Bd L8)
• Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer (ACT3) (Abstract 148 | Poster Bd J14)
• Phase II results of Circulating tumOr DNA as a predictive BiomaRker in Adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) Phase II/III Study (Oral Abstract Session; Abstract 5)

Guardant360®

• The genomic landscape of advanced colorectal adenocarcinoma patients with PIK3CA mutations using comprehensive cell free tumor DNA next generation sequencing (Abstract 181 | Poster Bd L9)
• Association of candidate alterations with primary resistance to KRAS G12D targeting in colorectal cancer (Abstract 170 | Poster Bd K18)

GuardantINFORM™

• Clinical utility of serial circulating tumor DNA (ctDNA) to identify acquired resistance to anti-EGFR antibodies in metastatic colorectal cancer (mCRC) (Abstract 158 | Poster Bd K6)
• Real-world testing and treatment patterns and outcomes following liquid biopsy in advanced cholangiocarcinoma (Abstract 455 | Poster Bd A20)
• Assessment of circulating tumor DNA (ctDNA) burden and association with outcomes in metastatic gastric cancer (mGC) patients using real-world data (RWD) (Abstract 276 | Poster Bd C14)

Shield™

• Enhanced blood-based colorectal cancer screening with improved performance in detection of early stage disease (Abstract 68 | Poster Bd E11)
• Circulating tumor DNA (ctDNA) positivity and its association with clinicopathological characteristics by novel blood-based test for colorectal cancer (CRC) screening from a multi-center large cohort: COSMOS-CRC-01 (Abstract 69 | Poster Bd E12)
• Prospective study of a multi-modal blood-based test for colorectal cancer screening (Abstract 70 | Poster Bd E13)

The full abstracts are available on the official ASCO 2024 GI Cancers Symposium website.

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 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 helping doctors select the best treatment 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, 2022, 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.