Guardant Health Initiates ORACLE Study to Evaluate Performance of Guardant Reveal™ Blood Test to Predict Recurrence Across Early-Stage Cancers

1,000-patient prospective study in 11 solid tumors will monitor ctDNA levels up to five years

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, has initiated the Observation of ResiduAl Cancer with Liquid biopsy Evaluation (ORACLE) study, a 1,000-patient prospective, observational, multi-center study designed to evaluate the performance of its Guardant Reveal™ liquid biopsy test to predict cancer recurrence after curative intent treatment, across 11 solid tumor types.

“For oncologists managing patients with early-stage cancer, there is a need for additional tools to help make informed decisions regarding risk for recurrence and benefit of adjuvant therapies, and avoid under- or over-treatment,” said Craig Eagle, MD, Guardant Health Chief Medical Officer. “This study is exciting because it will evaluate the first blood-only minimal residual disease (MRD) assay in additional tumor types, and set the stage to identify opportunities for this technology to improve patient care.”

The study will analyze circulating tumor (ctDNA) status from blood samples of patients with early-stage cancer, using the Guardant Reveal test after the end of treatment, and during routine follow-up. Participants will be followed until distant recurrence, or up to five years. The ORACLE study adds to currently underway clinical studies (COBRA, ACT-3, PEGASUS) evaluating the performance of the Guardant Reveal blood test in patients with early-stage cancer.

“Initiating this study adds to the growing body of evidence that will support the expansion of the Guardant Reveal blood test from its first indication of early-stage colorectal cancer to multiple cancer types. We believe our blood-only test can be a powerful and streamlined decision-making tool for oncologists managing patients with early-stage cancers,” said Helmy Eltoukhy, Guardant Health Co-CEO. “The ORACLE study exemplifies our commitment to further demonstrating the utility of our blood tests to improve long-term clinical outcomes.”

The Guardant Reveal test is the first blood-only liquid biopsy test that detects residual and recurrent disease from a simple blood draw. The test detects ctDNA in blood after surgery, to identify patients with residual disease who may benefit most from adjuvant therapy, and to detect recurrence months earlier than current standard-of-care methods.^1-6 The commercially available test achieves high sensitivity (91%)⁷ for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. The first indication of the test is colorectal cancer, with additional cancer types to follow.

More details about the ORACLE study can be found at NCT05059444.

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 GuardantOMNI^® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

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, 2020 and in its other reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended March 31, 2021. 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. Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncology. 2019; 5 (8): 1125-1131.
2. Tie J, Wang Y, Tomasetti C, Li L, Springer S, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Science Translational Medicine. 2016; 8 (346): 346ra92.
3. Tie J, Cohen J, Wang Y, et al. Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer. JAMA Oncology. 2019; 5(12): 1710-1717.
4. Peng J, Li Y, Mo S, Ma X, Hu X, Zhang L, et al. Prognostic value of circulating tumor DNA (ctDNA) detection during adjuvant chemotherapy in patients with stage III colorectal cancer: The interim report of a prospective, observational study. Journal of Clinical Oncology. 2020; 38, no.4_suppl.
5. Tarazona N, Gimeno-Valiente F, Gambardella V, et al. Targeted next-generation sequencing of circulating-tumor DNA for tracking minimal residual disease in localized colon cancer. Annals of Oncology. 2019; 30 (11): 1804-1812.
6. Reece M, Saluja H, Hollington P, Karapetis C, et al. The Use of Circulating Tumor DNA to Monitor and Predict Response to Treatment in Colorectal Cancer. Frontiers in Genetics. 2019; 10: 1118.
7. Parikh A, Van Seventer E, Siravegna G, Hartwig A, et al. Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients. Clinical Cancer Research. April, 2021; 10.1158/1078-0432.CCR-21-0410

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