Guardant Health Files Lawsuit Against Natera for Misleading Oncologists
May 28 2021 - 1:52AM
Business Wire
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Natera company website.
www.natera.com/oncology/signatera-advanced-cancer-detection/
Accessed online May 27, 2021
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Investor Contact: Carrie Mendivil
investors@guardanthealth.com
Media Contact: Anna Czene press@guardanthealth.com
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