Evaluate

My personal criteria for evaluating potential ME/CFS biomarkers and diagnostic blood test as a patient and non-scientist.

Patient Selection

How were patients selected for the study? How stringent were the criteria for patient selection? What ME/CFS criteria are being used? Has Post-Exertional Malaise (PEM) been provoked as part of the study? Have the investigators ascertained that each and every ME/CFS case has PEM?

FDA requirements and AUC curve

Have the investigators designed the Biomarker study to meet FDA requirements?

* Safety - is the test non-invasive
* Accuracy
* Sensitivity - able to correctly identify ME/CFS patients
* Specificity - able to correctly reject non-ME/CFS patients
* Have the investigators thought about clinical application? Are there obstacles to the clinical application of their test? Is there existing technology that can quickly put their test in a clinical laboratory setting?

https://www.fda.gov/drugs/biomarker-qualification-program/more-about-biomarkers-qualification

Testing against objective diagnosis

Recently, an Alzheimer’s blood test based on proteins was cleared by the FDA as a diagnostic blood test.

In 2024, the Alzheimer’s blood test was tested against the objective diagnosis of Alzheimer’s by spinal tap and MRI.

It is obvious that a ME/CFS diagnostic blood test will have to be evaluated by objective diagnosis of ME/CFS - likely by 2-Day CPET. So it becomes a question of whether the investigator is preparing for that eventuality.

Plan to meet with regulatory Bodies

Do the investigators have plan to meet with FDA/CHIR/NHS for guidance and application of their ME/CFS diagnostic blood test to obtain approval for use in a clinical setting?