Biomarkers can take the “process of elimination” out of diagnosing ME/CFS and Fibromyalgia. Biomarkers (short for biological markers) can be objectively measured and tell you something about the individual – whether there is disease present, what type of treatment should be used, etc. Once it is confirmed that a biomarker is useful for diagnosis or guiding treatment, it is developed into a test and commercialized.
Currently there are no commercially available biomarker tests for ME/CFS and Fibromyalgia despite the sizable literature describing biomarkers that have the potential for objective diagnosis and treatment. Why haven’t potential biomarkers like Natural Killer cells, cytokine profiles or autoantibodies been commercialized? Because no test can discriminate between patients that have a similar clinical presentation but different diseases, the “gold standard” for diagnosis of ME/CFS and Fibromyalgia is expert opinion. A test that can diagnosis these disease must be able to discriminate between a patient getting a diagnosis with the current gold standard (let’s call this person Patient A) and a patient who is suspected to have the disease but does not meet gold standard criteria (let’s call this person Patient B). Once we have a biomarker that can successfully do that, we’ll have a diagnostic test.
What is needed to make this happen? First you need that “gold standard” diagnosis. Currently the Bateman Horne Center has one of only a handful of ME/CFS and Fibromyalgia experts in the world. (We are working to change this by bringing these diseases into the medical mainstream, but until that happens we are one of the best resources for well-diagnosed patients.) Second, “research ready” patients are needed. The Bateman Horne Center has hundreds of expertly diagnosed patients (patient A described above) ready to participate in research and a network of providers that refer patients with suspect ME/CFS and Fibromyalgia (these include both A & B patients) to the Bateman Horne Center for diagnosis and treatment. Finally, you need the scientists who have the tools and technology to develop the biomarker tests. The Bateman Horne Center is partnering with academic scientists and industry to make objective diagnosis and treatment a reality for ME/CFS and Fibromyalgia.
Here’s an example of what the Bateman Horne Center has underway and in store for 2016:
- We’ve partnered with Drs. Isabel Barao and Dorothy Hudig of the University of Nevada, Reno to study ME/CFS in families to determine the role of genetics in Natural Killer cell function.
- We’ve partnered with Drs. Kathy and Alan Light of the University of Utah to confirm specific autoantibody patterns in ME/CFS.
- We are working with Eli Lilly, Daiichi Sankyo and Tonix Pharmaceuticals on Fibromyalgia clinical trials.
- We are working with Drs. Ian Lipkin and Mady Hornig to understand the microbiome in ME/CFS.
- We will be working with Dr. Michael Houghton and his team at the University of Alberta to confirm a potential diagnostic test for ME/CFS.
- We are co-investigators with Dr. Derya Unutmaz from the Jackson Laboratory of Genomic Medicine on an NIH application to examine immune cell populations in ME/CFS.
Bateman Horne Center is also leading one of the most innovative studies to begin to measure the diagnostic criteria for ME/CFS recommended by the Institutes of Medicine. We’ve assembled an amazing team of patients and partners to beta test the Oura ring and the tracking platform Curious. Read my blog about this super exciting beta test HERE
It is breathtaking what we were able to accomplish in 2015 and there are more collaborations taking shape at the Bateman Horne Center in 2016. I am confident that we have all the right ingredients to advance research and make objective diagnosis and treatment a reality for ME/CFS and Fibromyalgia.
Here’s to peace and progress in 2016.