Genomics player DxTerity Diagnostics landed a BARDA contract to develop and supply the authority with its radiation exposure dosage test, used to provide an estimate of absorbed radiation after a nuclear incident. The multiyear deal could be worth up to $150 million.
Devices that evaluate external radiation levels exist, but there is currently no FDA-approved test to measure how much radiation a person has absorbed. DxTerity’s REDI-Dx test analyzes a blood sample to determine an individual’s level of absorbed radiation following a large nuclear event. It measures the relative expression of 18 genes and then estimates the absorbed dose using an algorithm, according to a statement.
The two-year base contract will involve work worth more than $22.4 million to bring the device through clinical development and FDA filing, the company said in the statement. The contract also includes collaborating with BARDA to secure Emergency Use Authorization for the test and supply 40,000 tests to the Strategic National Stockpile. The duo has multiple options to extend the contract, which include maintaining a 400,000-test stockpile through 2026.
The device is initially intended for emergency use but has potential applications in cancer treatment. DxTerity’s RadTox radiation toxicity test is a blood test that could be used to assess a patient’s tolerance for radiation treatment and predict side effects of radiation in several cancers, the company said. It is in clinical studies and the company hopes to launch the test in 2017.
Meanwhile, the company is also working on tests for rheumatoid arthritis (RA) and other autoimmune diseases. It is developing a fingerprick blood test to help in treatment selection for RA patients and is launching a study to monitor disease activity at home using patient-collected blood samples and patient-reported information.