SBIR-STTR Award

Development of Diagnostic Test for Early Multiple Sclerosis
Award last edited on: 8/17/15

Sponsored Program
SBIR
Awarding Agency
NIH : NINDS
Total Award Amount
$299,998
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Steven E Schutzer

Company Information

Bioscience Development Inc

1467 3rd Avenue Suite 1R
New York, NY 10028
   (212) 452-1731
   schultzer@umdnj.edu
   N/A
Location: Single
Congr. District: 12
County: New York

Phase I

Contract Number: 1R43NS090908-01A1
Start Date: 4/1/15    Completed: 9/30/15
Phase I year
2015
Phase I Amount
$299,998
Multiple Sclerosis (MS) is a major neurological disease affecting over 400,000 Americans and 2.5 million worldwide. Pathological studies suggest these numbers should be doubled. In addition, the number of people with MS is increasing, especially in women. The disease has a devastating impact, and commonly produces disability in the motor, cognitive and vocational spheres. It is the most common non-traumatic central nervous system (CNS) disease of young adults, hitting them in what should be their most productive years. This causes personal hardship and loss to our workforce and the economy. Although there is no cure, there are FDA approved drugs that can prevent further deterioration of patients. They are most effective when given as soon as the diagnosis can be made. The bottleneck is how to make that diagnosis. The current study is designed to establish a diagnostic test for early MS. This would be a landmark achievement because no such test currently exists. Now diagnosis is based on history, examination, and a combination of suggestive but not conclusive laboratory testing. The diagnosis is typically delayed several years. A diagnostic test for early MS would be of critical importance for patients with this disease by allowing immediate institution of therapy. We will follow up on our recently published studies indicating protein biomarkers are present at this stage of the disease. Identification of such biomarkers is the basis of a diagnostic test. We will employ advanced proteomic techniques to accomplish this. Our team has the expertise and the necessary samples to do achieve this.This project provides the critical and necessary first step in identifying biomarkers for first-attack MS. Eventually the markers will provide objective diagnostic criteria and a possibly a response-monitoring tool for therapeutic trials. A reliable, objective diagnostic test fr MS will reduce disability and suffering including that for families, health care and lost productivity costs. We have the relevant samples, personnel to start immediately.

Public Health Relevance Statement:


Public Health Relevance:
Multiple Sclerosis is the major non traumatic central nervous system of productive adults. The cause remains unknown. Identification of diagnostic biomarkers, which distinguish this condition from others, will reduce suffering to the individual, and permit immediate therapy with FDA approved medicines.

Project Terms:
Achievement; Adult; Affect; American; base; Biological; Biological Markers; Blood Tests; Brain; Central Nervous System Diseases; Chronic; Clinical Trials; Cognitive; Control Groups; cost; Coupled; Data; design; Deterioration; Development; Diagnosis; Diagnostic; Diagnostic tests; disability; Disease; economic cost; Extracellular Fluid; Family health status; Fatigue; FDA approved; follow-up; Goals; Hand; Healthcare; Human Resources; Immune; Individual; Institution; Laboratories; Lead; Liquid Chromatography; Liquid substance; Lyme Disease; Mass Spectrum Analysis; Measurement; Medicine; meetings; Methods; Monitor; Morbidity - disease rate; Mortality Vital Statistics; Motor; Multiple Sclerosis; nervous system disorder; Neuraxis; Neurologic; Pain; Patient Care; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Play; Population; prevent; Productivity; Proteins; Proteome; Proteomics; public health relevance; Publishing; Recording of previous events; Resolution; Resources; response; Role; Sampling; Signs and Symptoms; Spinal Cord; Stable Isotope Labeling; Staging; Subarachnoid Space; tandem mass spectrometry; Techniques; Technology; Testing; Therapeutic Trials; tool; Translating; two-dimensional; United States National Institutes of Health; Validation; Woman; young adult

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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