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A rapid microfluidic P.O.C CNS biomarker platform to predict delayed HICP onset.

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
R43NS076107
Solicitation Year:
2012
Solicitation Topic Code:
NINDS
Solicitation Number:
PA11-096
Small Business Information
P2D, INC.
10101 Alliance Rd CINCINNATI, OH 45242-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2012
Title: A rapid microfluidic P.O.C CNS biomarker platform to predict delayed HICP onset.
Agency: HHS
Contract: 1R43NS076107-01A1
Award Amount: $348,668.00
 

Abstract:

DESCRIPTION (provided by applicant): The proposed SBIR program aims to develop a rapid point-of-care (POC) prognosticative assay device that provides clinically actionable data to predict onset of high intracranial pressure (HICP) after a severe traumaticbrain injury (sTBI). Delayed onset of HICP is a manifestation of secondary injury leading to poor patient outcome following TBI after a severe closed head injury. Early and even preemptive decompressive craniectomy prevents HICP onset and significantly improves outcome in severe TBI patients. Often, a lack of clinically actionable prognosticative information severity forces clinicians to be reactive than proactive in treating sTBI-associated HICP onset. Our proposed SBIR research and commercialization program is to develop a blood and CSF POC neuromonitoring device to predict and identify sTBI patients who will experience delayed HICP onset later. The POC device is based on microfluidic solid phase immunoassay ( fSPIA) principles, which permit rapid kinetics due to large surface area to volume ratios within the assay channels. We envision that resulting prognostic data will be actionable for clinicians in identifying sTBI patients at strong risk of delayed HICP onset. Based on the near-real time informationclinicians can initiate a preemptive decompressive craniectomy and improve clinical outcomes. We have identified seven lead biomarker proteins that are associated with sTBI in humans. Our Preliminary Studies also indicate their utility in predicting TBI-induced HICP onset. The proposed Phase I SBIR feasibility study will employ the fSPIA POC platform to measure our four candidate TBI biomarkers in serum from TBI rats. ELISA will be our gold standard comparator. We will use the controlled cortical impact-induced severe TBI rat model for these studies. Early measures of serum biomarkers will be employed to predict edema by Day 3 after severe TBI. Our Aims are: Aim 1: Develop and validate the fSPIA POC method for each of the seven TBI candidate biomarkers employing a traditional ELISA as the gold standard. Aim 2: Determine early time point changes in serum biomarker levels employing the fSPIA POC method and correlate it to changes in brain edema at later time point in rats with severe TBI. PUBLIC HEALTH RELEVANCE: Delayed onset of high intracranial pressure is a manifestation of secondary injury leading to poor patient outcome after a severe traumatic brain injury. The proposed SBIR program aims to develop a rapid point-of-care prognosticativeassay device that provides clinically actionable data by the patient bedside to predict onset of high intracranial pressure after a severe traumatic brain injury. This will assist clinicians to identify patients a risk for high intracranial pressure early and take proactive neurosurgical approaches to improve patient outcome.

Principal Investigator:

Somasundar P. Gabbita
513-475-6618
pgabbita@p2dinc.com

Business Contact:

Somasundar P. Gabbita
513-475-6618
pgabbita@p2dinc.com
Small Business Information at Submission:

P2D, INC.
10101 Alliance Rd CINCINNATI, OH 45242-

EIN/Tax ID: 120222472
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No