DxTerity Diagnostics Receives CE Mark for the REDI-Dx® Radiation Biodosimetry Test

DxTerity Diagnostics has declared conformity with the requirements of the European In Vitro Diagnostic Directive (98/79/EC) and has applied the CE mark to the REDI-Dx® Radiation Biodosimetry Test for the quantitative estimation of the absorbed ionizing radiation dose after a nuclear event.

DxTerity Diagnostics has declared conformity with the requirements of the European In Vitro Diagnostic Directive (98/79/EC) and has applied the CE mark to the REDI-Dx® Radiation Biodosimetry Test for the quantitative estimation of the absorbed ionizing radiation dose after a nuclear event.

According to Bob Terbrueggen, CEO and Founder of DxTerity, \"REDI-Dx fulfills a critical unmet need for responding to a mass scale nuclear event. It is the first CE-IVD assay for radiation biodosimetry and is designed to integrate into existing clinical testing infrastructure and read-out on the installed base of ABI 3500 Dx CE instruments.\"

The dicentric chromosome assay is the current \"gold standard\" in Europe and Asia; however, the limited testing capacity, lack of standardization, and 72-hour time to result limits its practicality. REDI-Dx overcomes these limitations with ambient sample shipping, 6-hour assay processing time, and a standardized CE-IVD kit for high throughput testing.

REDI-Dx is the result of a multi-year collaboration between DxTerity, Duke University, the University of Arizona, and Thermo Fisher Scientific; as well as patients and researchers from City of Hope Cancer Center and University of California Los Angeles. This project has been funded in whole or in part with Federal funds from BARDA under Contract No: HHSO100201000001C and Contract No: HHSO100201600034C.

Tags: Nuclear, Radiation, Contract

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