Lawsuit claims “99 percent accurate” test generates 30 percent false positivity rate among some patients
A manufacturer of diagnostic tests is facing a lawsuit over its claims that its tests for fibromyalgia and a condition the company calls “Immune Deficiency Disease” are false and misleading.
According to a complaint filed today by the nonprofit Center for Science in the Public Interest, the company, EpicGenetics, falsely claims its FM/a Test for fibromyalgia is “99 percent accurate” when the company’s own study indicates it generates false negative test results 7 percent of the time, and false positives nearly one-third of the time for individuals with rheumatoid arthritis or lupus.
EpicGenetics also allegedly markets an identical but differently named product, the 100Sure Test, as “100% accurate” in diagnosing “Immune Deficiency Disease,” or IDD. However, according to the complaint, that is not a medically recognized disease but rather a term created by EpicGenetics to fit the results its tests generate.
“That is, EpicGenetics, having failed to create a test that accurately diagnoses FM (the FM/a Test), has now created a disease (the so-called IDD) that fits that test’s results, and released a rebranded version of the underlying test (the 100Sure Test) as a diagnosis for this manufactured disease,” in the words of the complaint.
And for years, even after a 2021 exposé by Eric Boodman in STAT, EpicGenetics has marketed its $1,080 FM/a Test with false claims that those who test positive might be able to enroll in experimental treatment trials that could potentially cure their fibromyalgia.
Although the company funded and the FDA approved a 2017 fibromyalgia treatment trial at Massachusetts General Hospital, EpicGenetics founder Dr. Bruce Gillis pulled the funding for the study in 2018. Despite knowing the treatment trial would not go forward, EpicGenetics continued to falsely claim that people with positive FM/a Tests could volunteer for it, according to the complaint.
EpicGenetics recently announced another trial that will be conducted by a company that Gillis recently founded. But, based on EpicGenetics’ prior conduct and CSPI’s inability to find such a study registered on clinicaltrials.gov, the complaint alleges that this trial, if it is occurring at all, is unlikely to meet EpicGenetics’ promises of an “FDA-approved” trial “designed to eliminate the symptoms of fibromyalgia without the negative side effects of current treatments.”
In 2021, according to the lawsuit, the Centers for Medicaid and Medicare Services (CMS) suspended Medicare payments for the FM/a Test based on what it called “credible allegations of fraud,” in part because the test’s inaccuracy renders it medically unnecessary. The current status of that suspension is unknown because such CMS investigations are not public.
“It’s no secret that patients have had a hard time getting their doctors to take fibromyalgia and the pain it causes seriously, and EpicGenetics has exploited that frustration with false promises of being the world’s first objective and highly accurate fibromyalgia test,” said CSPI President Dr. Peter G. Lurie.
While serving as an associate commissioner at the FDA in 2015, Lurie authored a case study on 20 problematic LDTs that might cause harm to patients, including the FM/a Test.
“The concern with tests such as this, as with other laboratory-developed tests, is that false results cause people to seek treatment for diseases they don’t have, or not to get treatment for diseases they do,” said Lurie.
“It’s bad enough that EpicGenetics is making demonstrably false claims about the accuracy of its diagnostic tests,” said CSPI Litigation Director Lisa S. Mankofsky. “Based on their past conduct canceling promised treatment trials, we’re also very concerned that they are taking advantage of vulnerable patients by dangling the prospect of enrolling in a clinical treatment trial to encourage sales of their tests. We look forward to presenting evidence in court about EpicGenetics’ false claims.”
The CSPI lawsuit also draws attention to the lack of oversight over laboratory-developed tests, such as the FM/a Test. The FDA has historically not exercised its authority to regulate these tests, leading to the proliferation of inaccurate diagnostic tests that have caused significant harm to patients. CSPI has called on Congress and FDA to strengthen the regulation of LDTs.
On Friday, the FDA released a proposed rule to better regulate lab-developed tests. The proposal clarifies that LDTs are medical devices, meaning FDA will ensure they are safe and effective before they are sold to consumers.
The case is filed in Superior Court of the District of Columbia under the District’s Consumer Protection Procedures Act. Aside from Mankofsky, CSPI is represented by CSPI Litigator Matthew B. Simon, and Michael R. Reese and Charles D. Moore of the law firm Reese LLP.
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