CSPI Sues EpicGenetics Based Upon Claims of False and Misleading Statements on Fibromyalgia Test
The Center for Science in the Public Interest (CSPI) has filed a lawsuit against diagnostic test manufacturer EpicGenetics, alleging that the company’s claims about the accuracy of its test for fibromyalgia are false and misleading. The lawsuit asserts that EpicGenetics falsely promotes its FM/a Test for fibromyalgia as “99 percent accurate,” despite its own study revealing a 7 percent false negative rate and a nearly 30 percent false positive rate for individuals with rheumatoid arthritis or lupus.
The lawsuit also raises concerns about EpicGenetics’ marketing tactics, particularly its promotion of the $1,080 FM/a Test by falsely claiming that those testing positive could participate in experimental treatment trials to potentially cure fibromyalgia. Despite the company discontinuing funding for a 2017 fibromyalgia treatment trial at Massachusetts General Hospital, it continued making false claims about trial participation. The CSPI’s complaint questions EpicGenetics’ recent announcement of another trial and its likelihood to meet the company’s promises of an “FDA-approved” trial designed to eliminate fibromyalgia symptoms without negative side effects, given the company’s past conduct.
The FM/a® Test is an immunological blood test designed to analyze white blood cells’ chemokine and cytokine protein patterns in the immune system. It aims to identify abnormal patterns of these protective proteins, with the degree of abnormality scored on a scale from 1 to 100. This test has undergone peer-reviewed studies, been published in reputable medical journals, and is approved for reimbursement by multiple health insurance plans.
To clinically validate the test Professor Daniel Wallace, a leading rheumatologist from UCLA, conducted a study involving nearly 500 patients to investigate immune system biomarkers in relation to fibromyalgia. The findings from this research were presented at the 2013 American College of Rheumatology conference and subsequently published in a peer-reviewed medical journal, accessible in Rheumatology International. The study recruited 160 fibromyalgia patients, and 307 patients with other autoimmune diseases along with healthy controls. After analyzing cytokine concentrations following cell stimulation, each patient’s profile was scored using a statistical model. In the study, patients with fibromyalgia had statistically differentiated scores from the healthy controls and patients with other autoimmune disease. The assay showed a sensitivity of 93%, specificity of 89%, and high predictive values, making it a valuable tool for differentiating between these conditions and healthy individuals.
CSPI believes the lawsuit highlights challenges with the lack of oversight for laboratory-developed tests (LDTs) like the FM/a Test and calls for increased regulation by Congress and the FDA. The FDA recently proposed a rule to enhance the regulation of LDTs, designating them as medical devices to ensure safety and effectiveness before consumer sale.
The case is filed in the Superior Court of the District of Columbia under the District’s Consumer Protection Procedures Act.