Guardant Health filed suit against Foundation Medicine in a U.S. District Court in California for false advertising and unfair competition.
Guardant alleged in its complaint (PDF) that Foundation Medicine (FMI) made false and misleading statements in its advertising about the accuracy of Guardant360, Guardant’s liquid biopsy for cancer, as well as that of its own tests, which include tissue biopsy and a liquid biopsy, FoundationACT, which launched last year.
“These claims are based on cherry-picked, outdated and methodologically flawed data that exaggerate the purported accuracy of FMI’s assays while artificially denigrating Guardant360,” Guardant wrote in the complaint.
FMI touted its FoundationACT test as “best in class” with “unparalleled accuracy”—claims that Guardant alleged are false. For example, Guardant wrote that the sensitivity and specificity of FMI's FoundationACT is far lower than the 99% that FMI claims, according to data FMI presented at the American Society of Clinical Oncology’s annual meeting.
FMI also said in its advertising that the Guardant360 test is inaccurate and has a high rate of false positive results. But Guardant said this assertion is based on an inappropriate comparison of data—according to FMI, Guardant360 detects c-MET alterations, a mutation common in cancers that have developed drug resistance, in 15% of breast cancer patients vs. the 1% of patients in other studies found to have the mutation.
In making this comparison, FMI assumed the rate of c-MET alterations is the same for all breast cancer patients, Guardant said. In reality, the 15% figure comes from a study of patients with advanced cancer who had already undergone cancer treatment. Their tumors were therefore more likely to have developed resistance.
Guardant has asked the court to require FMI to “retract, remove and correct” its false and misleading claims and to instruct FMI to stop making or disseminating false and misleading statements about its own tests and Guardant360.
"We welcome competition because accelerating advances in oncology will benefit millions of patients," said Guardant CEO Helmy Eltoukhy, in a statement. "But it is vital that clinicians receive accurate and truthful information, because this affects patient safety. We believe that companies in the cancer diagnostics business—companies that must have patient care as their central mission—should not misrepresent science for commercial gain. When they do, we believe that appropriate corrective action must be taken."
FMI did not respond to a request for comment.
This isn’t the first time the pair has tussled. In May last year, FMI sued Guardant for patent infringement, alleging that Guardant violated its patent covering methods for analyzing a patient’s blood or tissue sample for genomic mutations.