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Should exercise testing be used in lieu of a biomarker?

There is also debate over the expressed need for a biomarker-that is, in order to confirm the illness in patients, a biomarker must be found. Dr. Friedman proposed the consideration of exercise challenge tests for their proven ability to measure and identify distinctive features of ME/CFS.

More specifically, exercise testing like the Stevens Protocol (i.e., the method developed by Staci Stevens at the University of the Pacific, Stockton, CA) has effectively detected multiple abnormalities unique to ME/CFS and objectively measured the reduced ability of ME/CFS patients to perform exercise and certain activities (i.e., those needed for sedentary work or activities of daily living).

Exercise testing can induce postexertional malaise (PEM)-now being recognized as the hallmark symptom of ME/CFS, and then it can quantify the effects of PEM on the patients' functional capacity.

As a result, this method is able to confirm the presence of this illness in patients. Having a tool available that could confirm or document ME/CFS could also facilitate the disability review process, and possibly accelerate the approval of the applicants and the release of their benefits. Dr. Friedman empathized with patients in how this is often a long and difficult process.

Furthermore, this type of tool could help to demonstrate efficacy of potential treatments, especially those which require FDA approval (i.e., Ampligen was mentioned as one treatment that needs to be pushed through). Therefore, Dr. Friedman has recommended the acceptance and utilization of exercise tests as a valid protocol in lieu of a biomarker.