PrecisionMed Inc. announces enrollment of the first donor into the PrecisionMed Amyotrophic Lateral Sclerosis (ALS) Registry. The PrecisionMed ALS Registry is a biological sample bank of DNA and longitudinal CSF, RNA, serum and plasma linked to clinical data utilizing PrecisionMed’s clinical data procurement and clinical sample management capabilities.
The PrecisionMed ALS Registry will enroll up to 2000 donors, with either sporadic or familial ALS. All donors will be recruited, evaluated, clinically studied, and sampled from up to 10 experienced investigative sites in the US. Key aspects of donors’ clinical status will be evaluated every four months with simultaneous biological sampling.
“PrecisionMed is dedicated to establishing cohorts of individuals for in-depth, longitudinal clinical and biological evaluation,” said John Flax, M.D., President and CEO of PrecisionMed. “In The ALS Registry, following establishment of baseline measures, the same validated measurements will be repeated every four months in order to quantify longitudinal changes, enabling correlation with biomarkers measured in corresponding samples. Accurate phenotyping is critical in relating changes in the clinical picture to alterations in molecular biomarkers. PrecisionMed has prior experience with longitudinal and single visit CSF banking projects in Alzheimer’s disease, mild cognitive impairment, schizophrenia, Parkinson’s disease, multiple sclerosis and 'True Normal' populations. These ongoing sample collections are an acknowledged, valuable source of highly annotated neuroscience samples, including CSF, to the research community worldwide.
“Prospective study of a large sample of individuals using the ALS Registry design will enable multiple pharmaceutical and academic researchers to study the progression of ALS, using a multiplicity of biomarkers. By integrating the laboratory and clinical data, it should be possible to obtain important information for drug discovery, disease diagnosis, prediction of response to treatments and disease prognosis. The track record of PrecisionMed in this kind of collection is excellent and bodes well that the data and samples will be of the highest quality.”
Longitudinal samples with matched clinical data, collected from the same donors every four months, are available to our clients. Custom requests for additional sample types, as well as more complex clinical, laboratory and/or radiographic evaluations within selected subpopulations will be entertained as the registry matures.