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...
US President made 7 claims, all false: Iran warns of closing Hormuz amid naval blockade: File photo (Source: Xinhua/IANS) Tehran, April 18 (IANS) Iran’s Parliament Speaker Mohammed Bagher Ghalibaf...