Guardant Health Files Lawsuit Against Natera for Misleading Oncologists

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today filed a lawsuit against Natera, Inc. for false advertising, unfair competition, and unlawful trade practices, relating to misleading statements Natera has made about its own products and the performance of Guardant Health’s new oncology test, Guardant Reveal™.

Guardant Health asked the federal court in San Francisco, California for an injunction preventing Natera from continuing to make these false or misleading statements and requiring Natera to take corrective actions.

Guardant Health’s recent introduction of Guardant Reveal™, the first blood-only liquid biopsy test to detect residual and recurrent disease in early-stage cancer survivors, represents an important medical breakthrough for the 1.5 million early-stage colorectal cancer survivors in the U.S.¹ Colorectal cancer is the second leading cause of cancer death in the U.S.² The Guardant Reveal™ test detects circulating tumor DNA (ctDNA) from a simple blood draw and is performed after surgery to identify patients with residual disease who may benefit most from adjuvant therapy and surveillance. The test can also detect recurrence months earlier than current standard-of-care methods, such as carcinoembryonic antigen tests or imaging.^3-8 Guardant Health’s method for ctDNA detection is vastly different from Natera’s Signatera assay, which requires a tissue-biopsy.⁹

The complaint alleges that Natera is misleading healthcare providers about the performance of the Guardant Reveal™ test by suggesting the test is inaccurate and/or insensitive, and inferior to Signatera™. As a direct result, colorectal cancer patients are missing opportunities for minimal residual disease (MRD) detection and recurrence monitoring, and the attendant benefits of guided treatment decisions.

“Guardant Health believes it is vital that clinicians receive accurate and truthful information, as this impacts potentially life-saving patient treatment decisions. We also believe that companies in the cancer diagnostics business must have patient care as their central mission and should not misrepresent medical science. When they do, we believe that immediate corrective action is required,” said John Saia, Senior Vice President, General Counsel and Corporate Secretary at Guardant Health.

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 Reveal^™ test 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.

The company’s flagship product, Guardant360, when introduced in 2014, was the first blood test that could comprehensively detect genomic mutations in patients with late-stage disease to see if they were eligible for a potentially life-extending personalized medicine. Since then, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers. The Guardant360 CDx is FDA- approved. The Guardant Reveal™ test leverages Guardant Health’s extensive blood-based testing experience and represents the company’s first product introduction to serve patients with early-stage cancer.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, such as statements related to the potential outcome of the ongoing litigation that is the subject of this press release and related matters. These statements are based on current expectations and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. Additional risks and uncertainties that could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the caption “Risk Factors” in Guardant Health’s 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. 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. 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 May 27, 2021.
2. Centers for Disease Control and Prevention. https://www.cdc.gov/cancer/dcpc/research/update-on-cancer-deaths/index.htm#:~:text=What%20were%20the%20leading%20causes,intrahepatic%20bile%20duct%20(5%25). Accessed online May 27, 2021.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Natera company website. www.natera.com/oncology/signatera-advanced-cancer-detection/ Accessed online May 27, 2021

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