NEW YORK (GenomeWeb) — The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded a contract worth up to $150 million to DxTerity Diagnostics to develop and deliver its REDI-Dx biodosimetry test for radiation exposure, the firm announced today.
The high-throughput test uses a blood sample and a panel of 18 genes to estimate absorbed radiation dose after a large scale radiation emergency. There are currently no tests approved by the US Food and Drug Administration to determine the amount of radiation a person has absorbed, DxTerity noted in a statement.
DxTerity's radiation test uses chemical ligation technology with fragment analysis results read out by capillary electrophoresis sequencing instruments.
The REDI-Dx test was developed based on a gene signature discovered by researchers at the Duke Cancer Institute. Duke partnered with DxTerity and the University of Arizona in 2009, and received initial funding at that time from BARDA to develop a low cost, high throughput test. Thermo Fisher Scientific also joined the collaboration, enabling the delivery on its clinical sequencing instruments.
The contract provides $22.4 million for the first two years to complete clinical studies and regulatory filing. DxTerity will initially work with BARDA to obtain Emergency Use Authorization for the test in early 2017. It plans to deliver 40,000 tests and DxCollect blood collection tubes to the Strategic National Stockpile in the second quarter of 2017, with subsequent contract options worth up to $150 million for maintaining a stockpile of 400,000 test through 2026.
The firm plans to submit the test and collection tubes to the US Food and Drug Administration for full approval in 2018.