A Rapid, Peripheral Blood Gene Expression Biomarker Panel for Diagnosis of Acute Ischemic Stroke
Posted Sep 19 2010 5:00pm
Description of Invention: There are presently no rapid, accurate diagnostic procedures or methods that can be used to determine whether a patient has suffered an acute ischemic stroke (AIS). Current technologies for diagnosis of AIS are limited by speed and resources as well as inaccuracy and generally require a high level of training to interpret the results for medical technicians. In contrast, this invention may lead to the development of a rapid and accurate clinical diagnostic kit that would require very little training for proper use and could be used in the field or the emergency room setting.
Scientists at the National Institutes of Health have discovered that expression levels of a set of nine genes may be used as biomarkers for diagnosis of AIS as well as outcome prediction. These biomarkers may be rapidly identified using peripheral whole blood and may form the basis of a rapid and accurate clinical point of care diagnostic kit.
Further, if validation is positive, this technology may enable rapid differential diagnosis between acute ischemic stroke and hemorrhagic stroke, transient ischemic attack, or any pathology mimicking a stroke. Not only can this be used to identify stroke earlier in the course of treatment, this panel may also help to better characterize stroke subtype, and identify new pathways for stroke treatment. This is important as the only FDA approved treatment for acute ischemic stroke is tissue plasminogen activator (tPA) and tPA must not be given to hemorrhagic stroke patients since it could increase intracranial bleeding. To effectively treat AIS, tPA must be administered intravenously within 3-4 hours of known stroke onset. Because the differential diagnosis of AIS versus hemorrhagic stroke is difficult without specialized imaging equipment such as a CT scan with contrast or an MRI image, only a small percentage of stroke patients (3-5%) are ever given tPA. So, a rapid and accurate clinical diagnostic kit based on this invention would have a profound public health benefit and likely a large commercial potential.
Applications:
A rapid and accurate clinical diagnostic kit for acute ischemic stroke.
Differentiation between acute ischemic stroke and a hemorrhagic stroke, transient ischemic attack, or any pathology mimicking a stroke.
Aid in the prediction of outcome and identify new pathways for ischemic stroke treatment.
Advantages: Faster, more accurate, and requires less training than currently available diagnostic procedures.
Development Status: Clinical Validation Pilot Study: whole blood was collected in a clinical setting and gene expressions were subsequently profiled.
Inventors: Taura L Barr (NINR) Maria Del Mar Matarin Jimenez (NIA) Steven J Warach (NINDS) Andrew B Singleton (NIA) Jinhui Ding (NIA) Allissa A Dillman (NIA) Mark R Cookson (NIA)
Barr TL, Conley Y, Ding J, Dillman A, Warach S, Singleton A, Matarin M. Genomic biomarkers and cellular pathways of ischemic stroke by RNA gene expression profiling. Neurology 2010 Sep 14;75(11):1009-1014. [ PubMed: 20837969 ]
Licensing Status: Available for licensing.
Collaborative Research Opportunity: The NINR is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a point of care test for ischemic stroke diagnostics and outcome prediction. Please contact Dr. Taura Barr at 304-293-0503 or barrt@mail.nih.gov for more information.
Portfolios: Gene Based Therapies Gene Based Therapies - Diagnostics Internal Medicine Internal Medicine - Diagnostics
For Licensing Information Please Contact: Jeffrey Clark Klein Ph.D. NIH Office of Technology Transfer 6011 Executive Blvd. Suite 325, Rockville, MD 20852 United States Email: kleinjc@mail.nih.gov Phone: 301-594-4697 Fax: 301-402-0220
Description of Invention:
There are presently no rapid, accurate diagnostic procedures or methods that can be used to determine whether a patient has suffered an acute ischemic stroke (AIS). Current technologies for diagnosis of AIS are limited by speed and resources as well as inaccuracy and generally require a high level of training to interpret the results for medical technicians. In contrast, this invention may lead to the development of a rapid and accurate clinical diagnostic kit that would require very little training for proper use and could be used in the field or the emergency room setting.
Scientists at the National Institutes of Health have discovered that expression levels of a set of nine genes may be used as biomarkers for diagnosis of AIS as well as outcome prediction. These biomarkers may be rapidly identified using peripheral whole blood and may form the basis of a rapid and accurate clinical point of care diagnostic kit.
Further, if validation is positive, this technology may enable rapid differential diagnosis between acute ischemic stroke and hemorrhagic stroke, transient ischemic attack, or any pathology mimicking a stroke. Not only can this be used to identify stroke earlier in the course of treatment, this panel may also help to better characterize stroke subtype, and identify new pathways for stroke treatment. This is important as the only FDA approved treatment for acute ischemic stroke is tissue plasminogen activator (tPA) and tPA must not be given to hemorrhagic stroke patients since it could increase intracranial bleeding. To effectively treat AIS, tPA must be administered intravenously within 3-4 hours of known stroke onset. Because the differential diagnosis of AIS versus hemorrhagic stroke is difficult without specialized imaging equipment such as a CT scan with contrast or an MRI image, only a small percentage of stroke patients (3-5%) are ever given tPA. So, a rapid and accurate clinical diagnostic kit based on this invention would have a profound public health benefit and likely a large commercial potential.
Applications:
Advantages:
Faster, more accurate, and requires less training than currently available diagnostic procedures.
Development Status:
Clinical Validation Pilot Study: whole blood was collected in a clinical setting and gene expressions were subsequently profiled.
Inventors:
Taura L Barr (NINR)
Maria Del Mar Matarin Jimenez (NIA)
Steven J Warach (NINDS)
Andrew B Singleton (NIA)
Jinhui Ding (NIA)
Allissa A Dillman (NIA)
Mark R Cookson (NIA)
Patent Status:
HHS, Reference No. E-023-2010/0
US, Application No. 61/307,233 filed 23 Feb 2010
Relevant Publication:
Licensing Status:
Available for licensing.
Collaborative Research Opportunity:
The NINR is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a point of care test for ischemic stroke diagnostics and outcome prediction. Please contact Dr. Taura Barr at 304-293-0503 or barrt@mail.nih.gov for more information.
Portfolios:
Gene Based Therapies
Gene Based Therapies - Diagnostics
Internal Medicine
Internal Medicine - Diagnostics
For Licensing Information Please Contact:
Jeffrey Clark Klein Ph.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Email: kleinjc@mail.nih.gov
Phone: 301-594-4697
Fax: 301-402-0220
Ref No: 2168
Updated: 09/2010