The project will enter a $5 million contract option as part of a potential $35.44 million project funded by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to extend feasibility testing for the development of a prototype that will measure gene expression in individuals exposed to abnormal levels of radiation.
Currently, no rapid, FDA cleared, high-throughput system exists to measure the radiation dose of individuals within a large population.
"As Japan's tsunami and resulting nuclear crisis has demonstrated, there is an urgent societal need to rapidly assess an at risk population's exposure to radiation," said Lee Cheatham, PhD, deputy director of the Biodesign Institute and lead investigator of the project. "Our ultimate goal is to develop a diagnostic system that would ensure that medical responders have the information necessary to provide appropriate medical treatment and ensure human health and safety."
ASU will continue to oversee the research program management, coordination and integration necessary for effective development of the technology, which will develop a high-throughput system for radiation biodosimetry that is capable of processing a high volume of blood samples per day for gene expression analysis on an automated liquid handling and imaging platform consistent with FDA guidelines.
Developing the system requires utilizing a biomarker signature set based on gene expression markers. This set of markers will provide a distinct indicator for the level of absorbed radiation. Along with Biodesign Institute biomarker research expert Dr. Joshua LaBaer, director of the institute's Virginia G. Piper Center for Personalized Diagnostics, will be collaborators with extensive experience in researching radiation responsive genes and development of microassay reagents and imagers, including: Sally Amundson, PhD, at Columbia University Medical Center, Bruce Seligmann, PhD, founder and CSO at HTG Molecular Diagnostics, Inc. and Amelia Bartholomew, MD, MHP, FACS at University of Illinois, Chicago.
"We are honored to be part of this multi-institutional program and believe our work with ASU has further established HTG's dynamic offerings," said T.J. Johnson, Chief Executive Officer, HTG Molecular Diagnostics.
The ASU effort is part of a BARDA initiative to feed the pipeline for advanced development, manufacturing, and regulatory activities that would position ASU's biodosimetry device for potential use in human triage and treatment decisions.
Provided by Arizona State University
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