The project is part of a potential $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 U.S. Department of Health and Human Services. The project is a collaboration with Life Sciences Solutions at Thermo Fisher Scientific and utilizes the Life Technologies brand of qPCR (quantitative polymerase chain reaction) instruments for analysis of gene expression.
“We are proud to be moving forward in this ambitious, challenging project that combines ASU’s considerable research strengths in biomarkers with Thermo Fisher’s expertise in the product commercialization process,” said Joshua LaBaer, director of the Biodesign Institute’s Virginia G. Piper Center for Personalized Diagnostics. “Our research team’s ultimate goal is to translate our discoveries for development of an automated high-throughput system for radiation biodosimetry that is capable of processing a high volume of blood samples per day for gene expression analysis.”
“We are very pleased that our colleagues at Arizona State University selected the Life Technologies brand of qPCR instruments for this important work to protect public safety,” said Chris Linthwaite, head of Genetic Systems Division, Research Platforms at Thermo Fisher. “The project represents a novel approach to deliver fast and accurate measures of absorbed radiation using molecular detection technology.”
Currently, no rapid, FDA cleared high-throughput system exists to measure the radiation dose absorbed by individuals within a large population. Of the eleven project teams launched in 2010, the ASU group is one of six continuing development of a medical device to address this application.
The Biodesign Institute at ASU is designing a multi-gene assay panel and collaborating with Thermo Fisher to develop a real-time quantitative PCR-based assay system to rapidly assess absorbed radiation dose. The Project is entering a $9M contract option to optimize the biomarker assay and platform workflow to prepare for testing needed to seek regulatory clearance for the assay from the U.S. Food and Drug Administration.
According to members of the ASU Biodesign Institute team, Thermo Fisher will lead the FDA submission process for the assay panel utilizing its PCR platforms that are currently listed with the FDA.
“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,” said Kristin Gillis, senior scientific project manager.
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.