Researchers at Australia’s Flinders University have identified a new potential biomarker in the urine of patients with amyotrophic lateral sclerosis (ALS).
Biomarkers are biological molecules found in body fluids, such as urine or blood, which can be a sign of disease or disease progression. These molecules not only help doctors diagnose a condition, but also help them understand how well the body responds to a particular treatment.
ALS currently has no validated biomarkers, and the newly identified molecule is the only biological fluid-based biomarker of disease progression. The newly identified biomarker is a protein called p75ECD. Previous work has shown that p75ECD levels are found in higher than normal levels in the urine of ALS patients.
The report, “Urinary p75ECD, A prognostic, disease progression, and pharmacodynamic biomarker in ALS,” appeared in the scientific journal Neurology.
“A standardized, easy-to-collect urine test could be used as a more accurate progression and prognostic biomarker in clinical trials,” said the study’s senior author, Dr. Mary-Louise Rogers, in a press release. “This will accelerate progress towards more rapid identification of improved treatments for [motor neurons disease] and save time and money by faster exclusion of less effective or ineffective drugs.
In order to evaluate whether p75ECD can be used as a reliable marker to diagnose and follow the progression of ALS, Rogers and her team measured the level of p75ECD in the urine of 54 ALS patients and 45 healthy volunteers.
They found, as in previous studies, that levels of this protein were higher in the urine of people with ALS compared to healthy individuals. The results did not change at different temperatures, or after the urine samples were frozen and thawed repeatedly or kept in the fridge for two days. It also didn’t matter what time of day or night the urine samples were collected.
Importantly, levels of p75ECD in the urine correlated with how advanced the ALS was, and rose as the disease progressed.
The authors concluded that in the future, p75ECD “could potentially be used to test people for early signs of pre-familial [ALS] progression and used instead of patient questionnaires for regular testing of disease progress or drug suitability in existing [ALS] cases.”