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A rapid blood test to aid the triage of patients affected by head injuries.

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43NS115309-01A1
Agency Tracking Number: R43NS115309
Amount: $223,966.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NINDS
Solicitation Number: PA19-272
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-01
Award End Date (Contract End Date): 2021-08-31
Small Business Information
5750 BAUM BLVD # 310
Pittsburgh, PA 15206-3793
United States
DUNS: 828862701
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ALBERTO GANDINI
 (832) 641-1900
 agandini@acceldx.com
Business Contact
 ALBERTO GANDINI
Phone: (832) 641-1900
Email: agandini@acceldx.com
Research Institution
N/A
Abstract

Project Summary
According to the CDC, in the U.S. over 2.8M emergency department visits are associated with
Traumatic Brain Injury (TBI) each year, and over 288,000 result in patientsandapos; hospitalization. TBI
ranges in degree, with over 75% of these injuries classified as “mild” TBI (mTBI), also referred to
as concussions. The clinical diagnosis of TBI and its severity remains challenging. Physicians
often resort to Computed Tomography (CT) scans to detect brain tissue damage or intracranial
lesions, and diagnose TBI. However, the majority of these scans are negative, as mTBI rarely
results in detectable lesions. As such, of the 1.5 million head CT scans performed every year on
possible TBI patients, as many as 80% are unnecessary. CT scans carry significant radiation
exposure, increasing the risk of radiation-induced cancer and economic burden. The prompt and
accurate triage of patients that should or should not receive a CT scan remains a major medical
challenge.
This SBIR Phase I proposal aims to develop and validate a point-of-care blood based diagnostic
device for triaging and managing patients presenting with head injury. The device, the pScreen-
TBI, leverages Accel Diagnosticsandapos; innovative and patented detection technology to accurately
quantify the level of two key biomarkers, known as UCH-L1 and GFAP. The use of these
biomarkers were recently cleared by the FDA to aid the evaluation of which patients affected by
head injuries should be CT scanned. The FDA decision is supported by numerous studies that
showed that elevated levels of these biomarkers have 99.7% sensitivity in determining which
patients have lesions visible on a CT scans and those which not with a 99.6% NPV (negative
predictive value). The pScreen-TBI incorporates, for the first time, the predictive power of these
biomarkers in a disposable, easy to use, and economic tool that delivers a rapid and sensitive
readout in an emergency and Point-of-Care setting. The device has clear utility for athletic and
battlefield injuries and motor vehicle accidents. First responders can use the device to make
decisions on patient need to be CT scanned, routing critical information to clinicians while en
route to the hospital via the connected smart-phone application.
Phase I efforts will focus on developing, optimizing, and validating a functional prototype for the
parallel quantification of UCH-L1 and GFAP from a single finger-stick blood sample. Specifically,
we will completed two Specific Aims: Aim 1) design and fabricate the dual-plex platform, select
the optimal pair of capture and detection antibodies, and optimize reaction components for each
biomarker; and Aim 2) conduct a comparative pre-clinical validation study against a gold-
standard, high-sensitivity lab-assay (ELISA) using human blood samples.
The proposed project is supported by extensive preliminary data, and a multi-disciplinary team
bringing industry and academia together, and including a biochemist, a physicist, two assay
development scientist, a neurosurgeon, a TBI biomarker discovery expert, a neuroscientist, and
the support of two of the Nationandapos;s leading TBI experts, Dr. B. Omalu (inspiration for the movie
Concussion), and Dr. J. Maroon (team neurosurgeon of the Pittsburgh Steelers).
In summary this Phase I addresses an unmet clinical need with significant commercial
opportunity. The successful development of this technology could minimize diagnostic uncertainty
and eliminating unnecessary procedures, leading directly to better overall health outcomes and
reduce costs.Project Narrative
Accel Diagnostics is proposing the development of an innovative blood diagnostic test to aid the
triage of patients presenting with head injury. Accel Diagnosticsandapos; technology could transform how
such injuries are handled in an emergency setting, resulting in significantly improved short- and long-
term health outcomes. Furthermore, this easy use, rapid, and affordable device would eliminate
millions of unnecessary Computed Tomography (CT) scans, reducing the risk of radiation-induced
cancers for million of patients and saving hundred of millions of dollars each year in avoidable
medical expenses.
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* Information listed above is at the time of submission. *

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