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Some of the “data” MarDx provided in their IgM Western blot application to the FDA. (MarDx WBs were 1st to be cleared after infamous #Dearborn conference.) A few interesting tidbits in here.

#LymeDisease #FOIA Image
My favorite: For their sensitivity study, MarDx included specimens of physician-diagnosed cases “relative to #LymeDisease case definition.” These undoubtedly would have been pre-screened arthritis samples from the Triangle of Death, Steere/Wormser/Dattwyler.
#LymeDisease Image
I can’t even imagine anyone today getting away with using “physician-diagnosed” samples to validate a #LymeDisease diagnostic device’s sensitivity. The crooks would surely protest. I’ve looked @ a lot of 510Ks & have never seen this before.
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