NEW YORK – A jury for a case heard in the US District Court for the Northern District of California on Monday awarded Guardant Health $292.5 million in damages related to a false advertising lawsuit that the firm brought against Natera in 2021.
In its suit, Guardant alleged that Natera engaged in false advertising, unfair competition, and unlawful trade practices relating to what it argued were misleading statements about a study of the performance of Guardant's Reveal minimal residual disease (MRD) assay. Guardant had claimed that Natera made false and misleading statements disparaging Reveal, asserting superiority of Natera's MRD assay Signatera in terms of sensitivity, failure rate, negative predictive value, and hazard ratio, among other categories. Guardant had also claimed that Natera cherry-picked data that elevates its own test while ignoring or mischaracterizing data that supports Guardant's.
Natera later countersued Guardant, claiming that the latter misled customers and the public with respect to its Guardant Reveal MRD assay. In particular, Natera alleged that Guardant had misrepresented the results of a study that have since served as the primary reference for promotional material related to Reveal.
"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," Guardant Health Chief Legal Officer John Saia said, adding, "we strongly believe it is vital that clinicians receive accurate, complete, and truthful information to inform their decisions about potentially life-saving patient treatments."
"We disagree with this decision and will ask the Court to overturn it," Natera said in a statement.
Natera also said in its statement that the case does not touch upon the validity or utility of Signatera and pointed out that "certain key pieces of evidence" supporting the Austin, Texas-based company's case were not included in the trial.
"Signatera has become the most widely used MRD test in the US," Natera stated, "extensively validated with published evidence in more than 100 peer-reviewed papers across multiple cancer types and indications."