On May 28, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company,reported that 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 (Press release, Guardant Health, MAY 28, 2021, View Source [SID1234583276]).
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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.