In GW Medical Technologies' Phase I effort, the company demonstrated the LymProTM (lymphocyte proliferation) Test's feasibility as a blood test for Alzheimer's disease. However, much work still needs to be done to fully prove the LymPro's capabilities and define its limitation before the Test can be useful in a clinical environment. In this proposed effort, GW Medical seeks the answers to those residual questions and prepares the Test for FDA applicable studies, through a series of non-clinical and clinical studies. Non-Clinical Studies include time and dose response, intra-subject longitudinal variability, sample stability and Test repeatability. In its clinical study, the company will expand the test's application to a broader variety of other, chronic, progressive, non-Alzheimer's dementia and validate the Test's performance by making Alzheimer's disease status determinations while blinded to the clinical diagnosis. ? The proposed Phase II effort aims to optimize, expand and validate the LymPro Test's performance as a diagnostic test for Alzheimer's disease and prepare the Test for FDA applicable studies. If proven, an easily administered test for Alzheimer's disease can improve the quality of life for the 400,000 plus Americans who are diagnosed with Alzheimer's disease each year and help reduce the $100 billion in annual costs associated with the disease by providing a more accurate and timely diagnosis. ? ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AG024719-04
Application #
7415165
Study Section
Special Emphasis Panel (ZRG1-BDCN-F (11))
Program Officer
Buckholtz, Neil
Project Start
2004-09-30
Project End
2009-01-31
Budget Start
2007-08-01
Budget End
2009-01-31
Support Year
4
Fiscal Year
2007
Total Cost
$520,618
Indirect Cost
Name
Provista Life Sciences, LLC
Department
Type
DUNS #
782449768
City
Phoenix
State
AZ
Country
United States
Zip Code
85016