Commentary on this paper from Andrea Martell: 'Replicated blood biomarkers for ME/CFS?'
Below is a portion copied from the text:
What we need
ME/CFS Biomarker research needs (in my Non-Scientist Opinion):
* A ME/CFS Biomarker Conference(s) to make decisions on how to design better biomarker studies and better Biobanks, showcase the ME/CFS biomarker studies that are now in various stages of development. A conference needs to decide on a biomarker protocol, a biomarker roadmap, Biobank criteria so that non-ME/CFS patients are not included (use of bad criteria) and begin the planning stages for how a ME/CFS diagnostic test will be tested against objective ME/CFS diagnostics (2-Day CPET) since that is likely what FDA/CIHR/NHS will require for regulatory approval.
* A strict biomarker protocol that outlines how ME/CFS cases should be characterized, defined, and clinically diagnosed for use in future ME/CFS biomarker studies. We need to our researchers to be able to compare apples to apples. But they have to be the best apples. If we set out a program of ME/CFS patient criteria that all ME/CFS Biomarker researchers must adhere to, it could help accelerate ME/CFS biomarker research.
* A ME/CFS Biomarker Roadmap modelled after the NIH ME/CFS Roadmap to showcase, and explain where we are in the development of a ME/CFS biomarker for a ME/CFS diagnostic blood test, and how far do we need to go to get that regulatory approval. We need Industry, and Media to publicly see ME/CFS diagnostic biomarkers in development, to find private and public partners for those biomarkers.
* A 2-Day CPET/ Hexoskin Biobank that includes ME/CFS blood samples collected at the time of 1-5 days of 2-Day CPET research, and blood samples from patients who have had PEM provoked by Moreau’s Cuff, and measured objectively with Hexoskin for 5 days. We need a biobank of blood, tissue, and medical records from patients who have had PEM provoked so that we A) Know they are ME/CFS patients B) Meet strict ME/CFS patient criteria C) So that ME/CFS biomarkers can be replicated against ME/CFS patient data sets with objective measurements of ME/CFS. In an ideal world, we would have recognized PET/MRI with TSPO tracer type of diagnosis for ME/CFS that was cheap and accessible so we could build up a biobank based on an imaging diagnosis, but I don’t know if that’s realistic or not. Dr. Michelle James, PhD, Scientific board member at Open Medicine Foundation, is working on clinical imaging for ME/CFS, but we haven’t had an update since 2023, as far as I know.
* We also need to consider Dr. Steven Deeks, MD’s advice that was given to LongCovid patients at PolyBio Symposium to model a Biomarker Program after the HIV Raven Program. Although, to my amateur eyes, the OMF way of Operating looks like VIPER already.
Below is a portion copied from the text:
What we need
ME/CFS Biomarker research needs (in my Non-Scientist Opinion):
* A ME/CFS Biomarker Conference(s) to make decisions on how to design better biomarker studies and better Biobanks, showcase the ME/CFS biomarker studies that are now in various stages of development. A conference needs to decide on a biomarker protocol, a biomarker roadmap, Biobank criteria so that non-ME/CFS patients are not included (use of bad criteria) and begin the planning stages for how a ME/CFS diagnostic test will be tested against objective ME/CFS diagnostics (2-Day CPET) since that is likely what FDA/CIHR/NHS will require for regulatory approval.
* A strict biomarker protocol that outlines how ME/CFS cases should be characterized, defined, and clinically diagnosed for use in future ME/CFS biomarker studies. We need to our researchers to be able to compare apples to apples. But they have to be the best apples. If we set out a program of ME/CFS patient criteria that all ME/CFS Biomarker researchers must adhere to, it could help accelerate ME/CFS biomarker research.
* A ME/CFS Biomarker Roadmap modelled after the NIH ME/CFS Roadmap to showcase, and explain where we are in the development of a ME/CFS biomarker for a ME/CFS diagnostic blood test, and how far do we need to go to get that regulatory approval. We need Industry, and Media to publicly see ME/CFS diagnostic biomarkers in development, to find private and public partners for those biomarkers.
* A 2-Day CPET/ Hexoskin Biobank that includes ME/CFS blood samples collected at the time of 1-5 days of 2-Day CPET research, and blood samples from patients who have had PEM provoked by Moreau’s Cuff, and measured objectively with Hexoskin for 5 days. We need a biobank of blood, tissue, and medical records from patients who have had PEM provoked so that we A) Know they are ME/CFS patients B) Meet strict ME/CFS patient criteria C) So that ME/CFS biomarkers can be replicated against ME/CFS patient data sets with objective measurements of ME/CFS. In an ideal world, we would have recognized PET/MRI with TSPO tracer type of diagnosis for ME/CFS that was cheap and accessible so we could build up a biobank based on an imaging diagnosis, but I don’t know if that’s realistic or not. Dr. Michelle James, PhD, Scientific board member at Open Medicine Foundation, is working on clinical imaging for ME/CFS, but we haven’t had an update since 2023, as far as I know.
* We also need to consider Dr. Steven Deeks, MD’s advice that was given to LongCovid patients at PolyBio Symposium to model a Biomarker Program after the HIV Raven Program. Although, to my amateur eyes, the OMF way of Operating looks like VIPER already.
