DxTerity Diagnostics said today it has been awarded an up-to-$150.1 million contract from the Biomedical Advanced Research and Development Authority (BARDA) toward development of its REDI-Dx® High Throughput Radiation Biodosimetry Test.

REDI-Dx is designed to determine individualized levels of absorbed radiation from a blood sample. The test measures the relative expression of a panel of 18 genes, using a proprietary algorithm to estimate the absorbed dose. According to the company, no FDA-approved test now exists for determining the amount of radiation that a person has absorbed, though devices are available that can measure levels of external radiation.

The BARDA contract consists of a base 2-year period of performance worth more than $22.4 million, during which time DxTerity plans to complete the clinical studies and regulatory filings required to obtain FDA approval for the test system and associated DxCollect® Blood Collection Tubes.

The initial contract also includes working with BARDA to obtain Emergency Use Authorization (EUA) for REDI-Dx and delivery of 40,000 tests and blood collection tubes to the Strategic National Stockpile. DxTerity said it expects REDI-Dx to be approved for EUA by the FDA in early 2017, followed by initial delivery of 40,000 tests and collection tubes in Q2 2017. The company plans to submit for full FDA approval in early 2018.

Subsequent contract options include the delivery of materials sufficient to maintain a 400,000 test stockpile through 2026, DxTerity added.

Bob Terbrueggen, Ph.D., DxTerity founder and CEO, said in a statement that REDI-Dx was created through a multiyear collaboration with Duke University, the University of Arizona, Thermo Fisher Scientific, and BARDA, as well as patients and scientists at institutions around the U.S. that have provided clinical samples.

Duke Cancer Institute Researchers Holly Dressman, Ph.D., Joseph E. Lucas, Ph.D., and John Chute, M.D., first discovered the gene signature that forms the basis of REDI-Dx in 2007 while comparing blood-based gene expression in healthy patients to patients who had undergone full-body radiation.

Two years later, Duke partnered with DxTerity and the University of Arizona, with BARDA funding, to develop a low-cost, high-throughput test based upon that gene signature. Thermo Fisher Scientific later joined the collaboration, enabling delivery of the company’s clinical sequencing instruments.

According to DxTerity, Duke Cancer Institute's gene signature research and DxTerity's genomic testing system have other potential clinical applications—from providing a method to evaluate a cancer patient's tolerance for radiation treatment to predicting radiation-induced side effects in various types of cancers.

DxTerity’s platform is also being used to develop low-cost tests for rheumatoid arthritis as well as other autoimmune diseases, Dr. Terbrueggen said.

Previous articleNovartis Shuts Some R&D Units; Expands Research in Cambridge, MA, and Basel
Next articleExercise Hormone Has Dual Role in Shedding and Preventing Fat