EpicGenetics’ False and Misleading Claims

According to CSPI's 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. 

The Complaint also alleged that EpicGenetics 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. 

Laboratory-Developed Tests

CSPI's lawsuit also called 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 May 6, 2024, FDA released a final rule to better regulate LDTs. The rule clarifies that LDTs are medical devices, giving FDA the right to regulatory oversight.

Successful Settlement of the Lawsuit

The lawsuit was resolved through a significant settlement, providing national relief. Among the relief provided under this settlement, the Defendant EpicGenetics, its founder and Chief Executive Officer Dr. Bruce Gillis, and three other related companies formed and controlled by Dr. Gillis (Bruce S. Gillis, M.D., M.P.H., Inc., Center For Immunology Science, LLC, and Immunology Diagnostics, LLC) agreed to the following:

  1. Cessation of the marketing and selling of the FM/a Test and 100Sure Test LDTs, including in the future;
  2. Limits on the claims they could make concerning a remaining LDT that they market and sell, the BSURE Test, for five years from the effective date of the Agreement;
  3. Limits on the claims that they could make about any future experimental treatment trials; and
  4. Limits on the claims that they could make about a dietary supplement that they offer for sale, called IMBXX, which they claim provides immunity support.