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April, 01, 2021

Guardant Health Receives New York State CLEP Approval for Guardant Reveal Blood Test to Detect and Monitor Residual Disease in Patients with Early-Stage Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH) announced that the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has approved the Guardant Reveal™ liquid biopsy test for the detection and monitoring of minimal residual disease (MRD) in patients with early-stage cancer (stage II and III). Guardant Reveal is the first blood-only test able to detect, with 7-day turnaround time, a patient’s status for residual disease, without the need for a tissue biopsy.

The Guardant Reveal blood test was introduced earlier this year and is Guardant Health’s first commercially available liquid biopsy for clinical use in the management of early-stage cancer. The test is focused first on one indication where the unmet medical need exists, early-stage colorectal cancer (CRC), with additional cancer types to follow. The Guardant Reveal blood test improves the management of CRC 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 test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic and epigenomic alterations. 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. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect residual disease in early-stage cancers including CRC.

“Securing New York State CLEP approval for Guardant Reveal means that oncologists in New York can now use the test to identify high-risk patients with colorectal cancer, our first indication, who may benefit from adjuvant therapy after surgery, and to detect recurrence earlier as part of regular surveillance,” said, Helmy Eltoukhy, Guardant Health CEO. “This approval is consistent with our commitment to improving care for all cancer patients by expanding access to our tests by complying with appropriate clinical laboratory regulations.”

There are over 1.5 million colorectal cancer survivors today in the U.S. and an estimated 10 percent to 30 percent of early-stage patients recur.8 An unmet medical need exists to offer new tests that can overcome the limitations of current tools.

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 Revealtest 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 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 scope, impact or benefit of Guardant Health liquid biopsies 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 as well as in its other reports filed with the Securities and Exchange Commission, including, when filed, 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.


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: Accessed online Feb 4, 2021.

Source: Guardant Health, Inc.

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Media Contact:
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Julie Johnson

Source: Guardant Health, Inc.

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