CSPI’s lawsuit alleges that EpicGenetics makes false and misleading claims about its laboratory-developed tests intended to diagnose fibromyalgia and “Immune Deficiency Disease.”
In October 2023, CSPI’s Litigation Department and its co-counsel filed a lawsuit on behalf of CSPI against EpicGenetics alleging that its claims about its laboratory-developed tests (LDTs) for fibromyalgia and a condition the company calls “Immune Deficiency Disease” are false and misleading.
EpicGenetics’ False and Misleading Claims
According to the Complaint, 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 30 percent of the time for individuals with rheumatoid arthritis or lupus.
EpicGenetics also allegedly falsely markets an identical but differently named product, the 100Sure Test, as “100% accurate” in diagnosing “Immune Deficiency Disease” (IDD). Noting that IDD is not a medically recognized disease (e.g., it is not listed in the ICD-10, a medical classification list managed by the World Health Organization), the Complaint asserts that IDD is a term created by EpicGenetics to fit the results its test generates.
And for years, EpicGenetics has marketed its 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.
This year, EpicGenetics 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 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.”
CSPI filed its lawsuit in the Superior Court of the District of Columbia as the plaintiff under the DC Consumer Protection Procedures Act, acting in a private attorney general capacity on behalf of DC consumers. The lawsuit argues that, based on EpicGenetics’ false and misleading claims, consumers paid more for the Tests than they are worth. Each of the Tests cost $1,080. The suit seeks to enjoin EpicGenetics from continuing its unlawful trade practices and ensure that future patients will receive truthful information about the Tests’ accuracy.
The lawsuit also draws attention to the lack of oversight over LDTs, such as the FM/a and 100Sure Tests. The FDA has historically not exercised its authority to regulate LDTs, 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 September 29, 2023, FDA released a proposed rule to better regulate LDTs. The proposal clarifies that LDTs are medical devices, meaning FDA will ensure they are safe and effective before they are sold to consumers.