By Oved Amitay, Solve M.E. President and CEO
Three studies were published last week, describing incredibly intriguing data, each pointing to specific biomarkers that can help to identify people with ME/CFS.
Two of the studies, conducted by Columbia’s Center for Solutions and the Jackson Laboratory, funded in part by the NIH’s ME/CFS Collaborative Research Network, found the gut microbiome to be significantly altered in ME/CFS patients, compared to the control group. Specifically, both research groups identified reduced levels of butyrate, a substance produced by bacteria in the gut, that serves as the major energy source for intestinal cells. Butyrate is critical to maintaining digestive health and reduces inflammation. Other metabolic abnormalities were found in the patients with ME/CFS, particularly in people who had a longer duration of the disease.
The third study, conducted by researchers at the Université de Montréal and their collaborators, funded by the Canadian Institutes of Health Research, investigated microRNA, molecules that control the expression of specific genes. Building on previous work that identified 11 circulating miRNAs associated with ME/CFS and using a machine-learning approach, the study provided a prediction model that can be used to distinguish between patients suffering from ME/CFS and those with fibromyalgia.
These rigorous studies examined different biological systems, but the common theme is, “Can we find a biological fingerprint that’s specific for ME/CFS?” The results provide convincing evidence that unique signatures may very well be identified.
At this point, you may be wondering when these tests are coming to a clinic near you. The answer is, unfortunately, not anytime soon.
These studies were done as part of scientific research, and there are actually quite a few steps that need to happen before they can generate reliable diagnostic tests that can be used in a real-world clinical setting. When using a clinical diagnostic test there’s a lot at stake, so there has to be the highest degree of certainty that the test provides reliable results.
First, the testing methods themselves would need to be validated, and the results would need to be replicated in larger studies, including people affected by other similar diseases. To do all of this work, clinically qualified laboratories would need to be used.
While government funding is essential for the discovery phase of these biomarkers, as was the case in these studies, additional resources would be critical for the development of clinical diagnostic tests that are based on these findings. Reliable diagnostics will also accelerate the development of treatments. However, this type of work is neither simple nor cheap, and further investments would be required by other public sources and private players to bring these scientific breakthroughs over the finish line.
Solve is actively seeking ways to get those stakeholders involved in addressing this unmet need for accessible diagnostic tools, in part by demonstrating the business opportunity.
This is why we are excited about our collaboration with BIO, the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries.
We’re co-hosting the event, “Long Covid: What Will It Take To Accelerate Therapeutic Progress?” on February 21 from 10:00 AM – 1:00 PM PT (1:00 – 4:00 PM ET). It convenes stakeholders to advance research and development to diagnose and treat Long Covid, ME/CFS, and other post-infection diseases.
I hope you’ll join us for this special event, which will feature opening remarks by Senator Tim Kaine (D-VA) and presentations by some of the most influential voices in Long Covid and ME/CFS research today. The event is free, and you can register for it here.