ME/CFS patients have waited many, many years to finally hear this news –– a biomarker for chronic fatigue syndrome has been identified!
Researchers at the Stanford University School of Medicine have developed a blood test that can accurately detect ME/CFS. How accurately? How does 100% sound?
According to the Stanford Medicine press release, “The test, which is still in a pilot phase, is based on how a person’s immune cells respond to stress. With blood samples from 40 people — 20 with chronic fatigue syndrome and 20 without — the test yielded precise results, accurately flagging all chronic fatigue syndrome patients and none of the healthy individuals.”
The research, which was published on April 29, 2019 in the Proceedings of the National Academy of Sciences, was funded by the Open Medicine Foundation and led by Ron Davis, PhD, professor of biochemistry and genetics at Stanford and Rahim Esfandyarpour, PhD, a former Stanford research associate who is now on the faculty of the University of California-Irvine.
Chronic Fatigue Syndrome Test on the Horizon
For patients, who have faced years of skepticism, accusations of faking it and being told “It’s all in your head,” the dream of a blood test that could provide an accurate ME/CFS diagnosis has remained elusive. But now it looks like their dream may finally be coming true.
The April 29, 2019 press release describes what led them to discover the test and how it works:
For Davis, the quest to find scientific evidence of the malady is personal. It comes from a desire to help his son, who has suffered from ME/CFS for about a decade. In fact, it was a biological clue that Davis first spotted in his son that led him and Esfandyarpour to develop the new diagnostic tool.
The approach, of which Esfandyarpour led the development, employs a “nanoelectronic assay,” which is a test that measures changes in miniscule amounts of energy as a proxy for the health of immune cells and blood plasma. The diagnostic technology contains thousands of electrodes that create an electrical current, as well as chambers to hold simplified blood samples composed of immune cells and plasma. Inside the chambers, the immune cells and plasma interfere with the current, changing its flow from one end to another. The change in electrical activity is directly correlated with the health of the sample.
The idea is to stress the samples from both healthy and ill patients using salt, and then compare how each sample affects the flow of the electrical current. Changes in the current indicate changes in the cell: the bigger the change in current, the bigger the change on a cellular level. A big change is not a good thing; it’s a sign that the cells and plasma are flailing under stress and incapable of processing it properly. All of the blood samples from ME/CFS patients created a clear spike in the test, whereas those from healthy controls returned data that was on a relatively even keel.
Test May Also Help Identify ME/CFS Treatments
In addition to potentially being able to offer a blood test that can provide an accurate ME/CFS diagnosis, the researchers believe the same technique can be used to screen for drugs that could have ME/CFS treatment possibilities. “Using the nanoelectronics assay, we can add controlled doses of many different potentially therapeutic drugs to the patient’s blood samples and run the diagnostic test again,” Esfandyarpour said.
The press release went on to explain:
If the blood samples taken from those with ME/CFS still respond poorly to stress and generate a spike in electrical current, then the drug likely didn’t work. If, however, a drug seems to mitigate the jump in electrical activity, that could mean it is helping the immune cells and plasma better process stress. So far, the team has already found a candidate drug that seems to restore healthy function to immune cells and plasma when tested in the assay. The drug, while successful in the assay, is not currently being used in people with ME/CFS, but Davis and Esfandyarpour are hopeful that they can test their finding in a clinical trial in the future.
All of the drugs being tested are either already approved by the Food and Drug Administration or will soon be broadly accessible to the public, which is key to fast access and dissemination should any of these compounds pan out.
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Currently there are no drugs with FDA-approval for treating ME/CFS. Any drugs used in the treatment of ME/CFS have to be prescribed off-label.
What Happens Next?
The next step is for the researchers to confirm their findings in a larger cohort of participants. Recruitment for the larger project, which aims to further confirm the success of the diagnostic test, is being done on a rolling basis. Those who are interested in participating should contact clinical research coordinator Anna Okumu.
In the video below, which explains their discovery and how it works, Davis explains more about what happens next. “[The] second phase is to try to figure out how to diagnose that it is ME/CFS and not some other related disease. That’s gonna take some time because we have to look through a…large number of other diseases, but that is proceeding at the moment.”
The Answer to “Is Chronic Fatigue Syndrome Real?”
ME/CFS patients have long known all too well just how real this disease is, but many others have remained skeptical. The development of this groundbreaking new test is the first step toward being able to prove it to the rest of the world. Soon when someone asks, “Is chronic fatigue syndrome real?” patients will be able to answer, “Yes, and I can prove it!”
VIDEO: Dr. Ron Davis, OMF Scientific Advisory Board Director, explains the PNAS publication on the nanoneedle – Video transcript is available here.
Karen Lee Richards is ProHealth’s Editor-in-Chief. A fibromyalgia patient herself, she co-founded the nonprofit organization now known as the National Fibromyalgia Association (NFA) in 1997 and served as its vice-president for eight years. She was also the executive editor of Fibromyalgia AWARE magazine. After leaving the NFA, Karen served as the Guide to Fibromyalgia and Chronic Fatigue Syndrome for the New York Times website About.com, then worked for eight years as the Chronic Pain Health Guide for The HealthCentral Network before coming to ProHealth. To learn more about Karen, see “Meet Karen Lee Richards.”
Esfandyarpour R, Kashi A, Nemat-Gorgani M, Wilhelmy J, Davis RW. A nanoelectronics-blood-based diagnostic biomarker for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Proc Natl Acad Sci U S A. 2019 Apr 29. pii: 201901274. doi: 10.1073/pnas.1901274116.