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Guardant Health Sues Foundation Medicine for False Advertising

NEW YORK (GenomeWeb) – Guardant Health has filed a lawsuit against Foundation Medicine alleging that its competitor has engaged in false advertising and unfair competition practices.

Guardant's complaint asserts that Foundation's advertising for its own liquid and tissue tests have harmed both Guardant Health and cancer patients by misleading oncologists about the relative accuracy and sensitivity of the competing genomic tests.

Guardant initiated the suit today in the US District Court for the Northern District of California under the Langham Act. Section 43(a) of the act provides that a "person who, or in connection with any goods or services . . . uses in commerce any . . . false or misleading description of fact or misleading representation of fact, which . . . in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services, or commercial activities, shall be liable to a civil action by any person who believes that he or she is likely to be damaged by such act."

Guardant and Foundation became rivals in the liquid biopsy space when Foundation launched and began marketing its blood-based FoundationACT last year.

More recently, Foundation sued Guardant, alleging infringement of US Patent No. 9,340,830, which covers methods for analyzing a cancer patient's tissue or blood sample to detect multiple classes of genomic alterations.

In its own suit, Guardant is arguing that Foundation's recently launched blood test FoundationACT "cannot compete on the merits with Guardant360 in the fast-growing market for cell-free DNA cancer assays." As a result, Foundation has instead undertaken a "campaign of misinformation" to convince doctors to avoid Guardant360 in favor of Foundation Medicine's own liquid and tissue-based assays.

Foundation has asserted in its marketing materials that its test is "the only commercially available molecular information platform that comprehensively assesses cancer simultaneously for all four classes of genomic alterations . . . across all cancer-related genes with the sensitivity and specificity required for routine medical practice." These claims of superiority and market-leading performance lack merit, Guardant wrote, when Foundation Medicine's blood-based test interrogates fewer genes and has less validation data backing it up than Guardant's does.

According to Guardant, Foundation has not only falsely stated in its marketing that its test is the "best in class" with "unparalleled" sensitivity and more reliable results than Guardant's, but has also stated falsely that Guardant360 has a higher rate of false negative and false positive results.

These marketing claims are based on "cherry picked, outdated, and methodologically flawed data that exaggerate the purported accuracy" of Foundation's approach and "artificially denigrate" Guardant360, the company added.

For example, Guardant wrote in its filing, Foundation has claimed in its marketing that clinical data show Guardant360 detects cancer-related genomic alterations in only 58 percent of patients, while Foundation's tissue test FoundationOne detects cancer-related genomic alterations in up to 98 percent of patients tested. The marketing materials also state that Guardant's test only detects actionable genomic alterations in 39 percent of patients, while FoundationOne detects actionable alterations in up to 90 percent of cancer patients.

In both cases, Guardant says that the data on Guardant360 are derived from outdated information from a single study on a version of the test that has not been used since 2014.

"Purporting to characterize an eighth-generation product based on its first iteration is inherently deceptive," Guardant wrote. "More importantly, at the time FMI made those claims, published data showed that the clinical sensitivity of even the early version of Guardant360 was, in fact, 85 percent," the firm added.

Meanwhile, Guardant highlighted data that it argued has demonstrated that Foundation's offerings are actually less sensitive and specific than Guardant360. For example, the company said that Guardant360 showed 85 percent clinical sensitivity in a recent study, while tissue tests from Foundation reached only 62 percent, primarily due to a high rate of untestable samples.

Guardant also claims that Foundation has misled customers as to Guardant360's potential for false positives by suggesting that since the liquid biopsy test picks greater frequencies of certain mutations, that these must be false-positives. Specifically, Foundation cited a study in which Guardant's test picked up c-MET alterations in 15 percent of breast cancer patients. Foundation compared that with a 1 percent rate for these mutations in data from The Cancer Genome Atlas, and less than one percent in results from its own FoundationOne tissue test.

However, Guardant calls this a "sleight of hand," based on an incorrect comparison of data across breast cancer patients, because Guardant's results were from a cohort of only advanced, heavily pre-treated cancer patients in which increased c-MET would be expected.

"FMI did not re-test the same advanced breast cancer patients tested in the Guardant360 study, and has no other reliable evidence that the Guardant360 results are wrong," Guardant argued. "FMI fails to disclose the differences in the patient groups used in its comparison, and its claim that Guardant360 will misidentify patients as having a c-MET alteration 14 times out of 15 positive tests is unsupported and literally false."

In another example, Guardant highlights marketing by Foundation that references a letter published in the Journal of Thoracic Oncology this February. In the letter, Foundation researchers reported a single case study in which Guardant360 returned a negative result, but Foundation's testing uncovered a potentially treatable ROS1 fusion.

Foundation's advertising warns of "profound clinical impact" from this purported difference. However, Guardant wrote, the finding is the result of a "rigged test."

Guardant's testing of the patient was performed prior to chemotherapy, while the sample analyzed by Foundation was taken after treatment had started. Either the simple passage of time or chemotherapy treatment could have increased the levels of ctDNA in the patient's blood.

Moreover, Guardant asserts that Foundation knew that this case study was "fundamentally flawed" before launching its advertising campaign. Guardant researchers analyzed a replicate blood sample taken from the same patient at the same time and found the same mutations that Foundation did. Though the company notified Foundation of this finding six months prior to publication of the letter, the authors omitted these results.

"FoundationACT did not 'uncover what [Guardant360] missed' and FMI's warnings of 'profound clinical impacts' based on this untrue claim are false and misleading," Guardant argued.

After citing these examples, Guardant states that what it argues has been false advertising on Foundation's part has had a material effect on its own business, misleading oncologists, healthcare institutions, and other potential customers, and "causing these customers to purchase the FMI assays rather than Guardant360."

Further, Guardant alleged, "False statements regarding Guardant360 have injured the reputation of this product and the reputation of Guardant itself, costing Guardant customer good will and causing the loss of future sales." Moreover, "patients have missed the opportunity to benefit from liquid biopsies using Guardant’s superior product," the firm added.

Guardant has asked the court to enjoin Foundation from continuing to disseminate false or misleading statements about the performance of its own assays as well as the performance of Guardant's test, and to require Foundation to retract, remove, and correct these advertising claims.