Nov 17 2010
PrecisionMed Inc. today announced at the Society for Neuroscience annual meeting in San Diego, enrollment of the first subject into the PrecisionMed Multiple Sclerosis (MS) Registry. The PrecisionMed MS Registry is a biological sample bank of DNA and serial RNA, CSF, serum and plasma associated with serial clinical testing utilizing PrecisionMed's clinical data procurement and storage capabilities.
“PrecisionMed is dedicated to establishing cohorts of individuals for in depth longitudinal clinical and biological evaluation”
The PrecisionMed MS Registry is a collection of correlated data and biological samples expected to be of value for the investigation of markers of Multiple Sclerosis and Clinically Isolated Syndrome (CIS).
The PrecisionMed MS Registry will enroll up to 300 subjects, with either Clinically Definite Multiple Sclerosis or Clinically Isolated Syndrome, aged 18 years and older. All subjects will be recruited, evaluated, clinically studied, and sampled from 12-15 US based, experienced investigative sites. Enrollment has begun and is expected to take about 2 years to complete. Key aspects of subjects' clinical status and medications will be evaluated every six months with simultaneous biological sample banking for a period of 5 or more years. Clinical samples and data will be made available to clients on a regular basis. Special attention will be paid to maintaining patients in the study by providing incentives for continued participation to patients.
"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 MS Registry we will establish robust baseline clinical status using the same validated instruments every 6 months and thus any ongoing change will be accurately and repeatedly quantified. In neuropsychiatric disease specifically, accurate phenotyping is critical in relating changes in the clinical picture to alterations in biology. PrecisionMed has prior experience with longitudinal and single visit CSF banking projects involving Alzheimer's disease, schizophrenia, Parkinson's disease and control populations, maintaining ongoing collections of samples from these populations which include CSF. The MS Registry complements the ongoing ACE and SAMPLE registries, both of similar design.
"Prospective study of a large sample of individuals using the MS Registry design will enable multiple pharmaceutical and academic researchers to study the evolution of MS and CIS, using a multiplicity of biomarkers. By integrating the laboratory and clinical data, it should be possible to obtain important information for drug discovery, diagnosis, prediction of response to treatments, and 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."
Six monthly samples with matched clinical data will be available on a longitudinal basis 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.
Source: PrecisionMed Inc.
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