by Hannah Thomasy – Drug Discovery News
Extracts
Where to go from here
Determining biomarkers for ME/CFS is still an area of active research. Most scientists are exploring different approaches simultaneously rather than putting all of their eggs in one basket.
Davis, who developed the Nanoneedle, and his team are developing a diagnostic test using neutrophils, an important component of the innate immune system which may be dysfunctional in people with ME/CFS.
Hanson, who developed a proteomics-based test, is also studying gene expression in muscle cells, immune cell dysregulation, and dysfunction of the endothelium, the thin membrane lining the inside of the cardiovascular system.
Still others are analyzing blood cells with Raman spectroscopy, interrogating the gut microbiome, and investigating brain activity using multimodal magnetic resonance imaging.
In short, said Moreau, “We’re looking at everything.” Some researchers, including Moreau, believe that these diagnostic biomarkers are crucial for the success of future clinical trials. These biomarkers will be helpful for assessing treatment efficacy, and since the disease may exhibit substantial heterogeneity between individuals, they may also help determine which types of patients respond to which therapies. This view is not universal, however
“I have heard people say that we can't have clinical trials for ME/CFS because we don't have a molecular marker. In my mind, that is ridiculous. You can still have clinical trials using health surveys that have been vetted and tested that are used in other diseases to find out whether a drug is doing any good,” said Hanson
Hanson noted that there are other diseases such as depression that do not have validated biomarkers, but nevertheless, scientists perform clinical trials and identify effective drugs. While emphasizing that ME/CFS is by no means a mental health condition, Hanson noted that a lack of biomarkers does not render effective drug development impossible, even for heterogeneous conditions.
While they don’t agree about everything, researchers do generally agree that while scientific developments in the understanding of the molecular underpinnings of the disease and the ability to diagnose it are important, more education and acceptance in the medical community is also sorely needed.
“It is important to have a test, but I really don't know how successful it will be until we educate the doctors,” said Davis.