A federal court jury has sided with Guardant Health, which had claimed that rival cancer test developer Natera went too far in advertisements for its competing assay to monitor patients for the return of their colorectal tumors.
The jury awarded Guardant $292.5 million, including $175.5 million in punitive damages, which the company described as one of the largest false advertising verdicts in history. The jury also rejected Natera’s counterclaims.
The lawsuit, first filed in May 2021, centers on Guardant’s Reveal liquid biopsy test, which probes for fragments of tumor DNA circulating in the bloodstream to detect residual or recurrent colorectal cancer, following surgery and other therapies.
In its original complaint, lodged in the Northern California federal court covering San Francisco and Silicon Valley, Guardant said Natera made false claims when comparing Reveal to its own Signatera blood test for minimal residual disease—including representations of the tests’ sensitivities and predictive values.
Amid Reveal’s commercial launch in February 2021, Guardant said Natera sent advertisements to oncologists and other potential customers stating a “concern about other laboratories rushing into the clinical MRD market and making potentially misleading claims with no peer-reviewed evidence, which may be detrimental to patients,” without mentioning the Reveal test by name.
Natera also characterized Guardant’s approach as “tumor-naive,” as opposed to “tumor-informed.” Signatera, by comparison, begins with a sample of an individual patient’s own colorectal cancer tissue and uses it to build a personalized assay that seeks out their specific mutations. After that, a patient’s plasma is screened about once every three months to see if the tumor has returned. Reveal, meanwhile, is designed to rely only on blood plasma.
In addition, Guardant had claimed that Natera misrepresented Reveal’s accuracy in white papers and investor materials and that it drew comparisons based on separate studies of each test using different patient populations and methods.
“Today's unanimous verdict holding Natera responsible for engaging in illegal and anticompetitive conduct represents a major victory for CRC patients who could benefit from our groundbreaking Reveal test, and we thank the jury and the court for their careful consideration of our claims,” Guardant’s chief legal officer, John Saia, said in a statement.
“Every company in the cancer diagnostics space has a duty to prioritize patients above all else. In keeping with our mission to help cancer patients lead longer and healthier lives, we strongly believe it is vital that clinicians receive accurate, complete, and truthful information to inform their decisions about potentially life-saving patient treatments,” Saia added.
Natera said that it disagreed with the jury’s decision and plans to ask the court to overturn it.
“The jury was asked to evaluate comparative advertisements that ran for a brief period in 2021 related to the performance of Guardant’s Reveal test. This case had nothing to do with the validity or utility of Signatera, and certain key pieces of evidence supporting Natera’s case were not included in this trial,” the company said in its own statement.