Biodesign and Thermo Fisher to Rapidly Assess Absorbed Radiation Dose

The project is entering a USD 9 million contract option to optimize the biomarker assay and platform workflow to prepare for testing needed to seek regulatory clearance for the assay from the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

The new USD 9 million phase of a multimillion, multi-institutional development project aims to produce a diagnostic test to measure rapidly an individual’s level of absorption of ionizing radiation in the event of an unplanned radiological or nuclear event. Currently, no rapid, FDA cleared high-throughput system exists to measure the radiation dose absorbed by individuals within a large population.

The project is part of a potential USD 31.2 million in total funds authorized by the Biomedical Advanced Research and Development Authority (BARDA), a federal agency within the Office of the Assistant Secretary for Preparedness and Response of the US Department of Health and Human Services. BARDA uses a comprehensive portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing infrastructure building of the necessary vaccines, drugs, therapeutics, diagnostic tools, and nonpharmaceutical products for public health medical emergencies including chemical, biological, radiological and nuclear threats, as well as pandemic influenza, and emerging infectious diseases.

The Biodesign Institute addresses today’s critical global challenges in health care, sustainability and security by developing solutions inspired from natural systems and translating those solutions into commercially viable products and clinical practices.

The project is a collaboration with Life Sciences Solutions at Thermo Fisher Scientific and utilizes the Life Technologies brand of quantitative polymerase chain reaction (qPCR) instruments for analysis of gene expression.

Kristin Gillis, senior scientific project manager noted, “As part of the project, the Biodesign Institute has developed a high-quality, biomarker discovery core competency utilizing next generation sequencing and gene selection algorithms that can reproducibly identify and select biomarkers. Our process includes quality control standards and can be applied to many other medical challenges for research, diagnosis, or development of a therapeutic.”

Collaborators to the team, along with Biodesign Institute biomarker research expert Dr. Joshua LaBaer, director of the institute’s Virginia G. Piper Center for Personalized Diagnostics, include Sally Amundson, PhD, at Columbia University Medical Center, who has extensive experience in researching radiation responsive genes, and ASU’s strategic partnership with Mayo Clinic, where Dr. William Wong will provide critical access to patient clinical samples needed for biomarker development.

Related Links:
The Biodesign Institute
Arizona State University
Thermo Fisher Scientific