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February, 16, 2021

Guardant Health Launches Guardant Reveal™ Liquid Biopsy Test for Residual Disease and Recurrence Monitoring in Patients with Early-Stage Colorectal Cancer

Guardant Reveal is industry’s first blood-only test able to detect, with 7-day turnaround time, residual disease after surgery and recurrence months earlier than current standard-of-care methods

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced the availability of Guardant Reveal™, the first blood-only liquid biopsy test for the detection of residual and recurrent disease from a simple blood draw. The first-of-its-kind commercial test improves the management of early-stage colorectal cancer (CRC) patients by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.1-6

The Guardant Reveal test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. The test accurately reports genomic alterations down to allele frequencies of 0.01 percent, and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis of indeterminate potential. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect early-stage cancers including CRC. Results are obtained from a simple blood draw and returned in as little as 7 days without the need for a tissue biopsy.

“For the more than 1.5 million colorectal cancer survivors today in the U.S.8, the risk of recurrence is a serious one. Colorectal cancer is the second leading cause of cancer death in the U.S. and an estimated 10-30 percent of early-stage patients recur8—so it’s vital that oncologists have better tools to manage these patients by quickly identifying those high-risk patients who may benefit from adjuvant therapy after surgery, and by detecting recurrence earlier as part of regular surveillance,” said Helmy Eltoukhy, Guardant Health CEO. “At Guardant Health our goal is to help cancer patients across the care continuum, and with the Guardant Reveal test, we are now able to serve an earlier patient group, early-stage colorectal cancer patients, where an unmet medical need exists given the limitations of current tools.”

“The use of liquid biopsies in clinical practice represents a new frontier in improving cancer care for patients at all stages of their disease,” said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. “It’s exciting to see that Guardant Health’s liquid biopsy tests not only inform targeted therapies for advanced cancer patients, but can now detect signs of cancer in the blood after curative intent surgeries. With this test, clinicians now have an additional tool to evaluate whether a patient with early-stage colorectal cancer is at high risk for recurrence, helping to inform adjuvant treatment after surgery in certain settings, and to detect microscopic recurrence of cancer months earlier than today’s standard of care.”

The Guardant Reveal test is Guardant Health’s first commercially available liquid biopsy test for clinical use in the management of early-stage cancer. The test will focus first on one indication where the unmet medical need exists, early-stage CRC, with additional cancer types to follow.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood 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 liquid biopsy-based Guardant360®, Guardant360 CDx, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Revealfor 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 and individuals at a higher risk for developing cancer with early detection.

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, 2019, in its Quarterly Reports on Form 10-Q for the periods ended March 31, 2020, June 30, 2020, and September 30, 2020, respectively, and in its other reports filed with 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.

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. Under Review. Data on file.
8. American Cancer Society: Colorectal Cancer Facts & Figured 2020-2022. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf. Accessed online Feb 4, 2021.

Source: Guardant Health, Inc.

Investor Contact:
Carrie Mendivil
investors@guardanthealth.com

Media Contacts:
Anna Czene
press@guardanthealth.com

Courtney Carroll
courtney.carroll@uncappedcommunications.com

Source: Guardant Health, Inc.

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