FA864924P0494

Small Business Innovation Research Program (SBIR) Phase II

Novel Blood-based Test for Traumatic Brain Injury and Alzheimer’s Disease Screening

Reliable-LFC is developing a new application of their Enzyme-Linked ImmunoSorbent Assay-Polymerase Chain Reaction (ELISA-PCR), addressing the need for an objective, inexpensive, simple to perform, high throughput and ultra-high sensitivity screening system that can stratify Traumatic Brain Injury (TBI) patients to determine treatment regimens and detect Alzheimer's Disease (AD) before the onset of symptoms. The DAF and the DoD service members & veterans are at risk of brain injury from explosions experienced during combat or training exercises. Explosive blasts account for a majority of the injuries among wounded service members. Depending on the severity of the brain injury, a person with TBI may experience a change in mental functioning that can range from being dazed and confused to losing consciousness. In addition, TBI may lead to co-occurring health conditions, such as post-traumatic stress disorder (PTSD) and depression, and even dementia and AD with accompanying significantly increased downstream healthcare costs. Reliable-LFC's ELISA-PCR has higher specificity, ultra-high sensitivity, and quantitative ability compared to competitive technologies, making it a robust, state-of-the-art protein detection tool for TBI and AD early screening. Further, this test is conducted in 96- or 384-well plates providing highly appropriate means for both small- and large-scale testing operations. Importantly, its easy-to-perform protocol using existing equipment and fast Turnaround Time (TAT) make the Reliable-LFC's test the best option for a readily accessible, quick and accurate stratification of individuals once exposed to an inducing event. Reliable-LFC's team comprises highly skilled and experienced researchers in chemical engineering, molecular cell biology, biochemistry, as well as in business with a proven track record of success in entrepreneurship and science. Reliable-LFC's core team has commercialized over 20 products or product families, most of which have been approved or cleared by the FDA. Reliable-LFC will address the US Defense market for TBI and AD diagnosis with over 1.3 million active-duty DoD members across 197 DoD/VA facilities.

The goal of phase II is to continue the R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II.

AFX235-CSO1

FX235-CSO1-0140

X23.5

Jenna Roeche