REDI-Dx® Radiation Biodosimetry Test is the first CE-IVD assay for radiation biodosimetry with high throughput testing. REDI-Dx provides a quantitative estimation of an individual’s absorbed radiation dose after a nuclear event, based on a peripheral blood sample, and is designed to integrate into existing clinical testing infrastructure and read-out on the existing installed base of ABI 3500 Dx CE instruments.
A radiological event, from the use of a nuclear weapon or a large-scale radiological disaster, could potentially expose thousands to high or moderate levels of radiation that would require immediate assessment and medical intervention. However, post-event medical response will be complicated by the often “silent” and delayed symptoms of acute radiation syndrome (ARS), as well as the high level of fear many people have of radiation. Detonation of an Improvised Nuclear Device in a major population center is likely to result in many thousands injured, as well as even a larger population of the concerned public.
After such a mass-scale radiological event, hospitals and clinics will be inundated with patients presenting a range of conditions from mere anxiety to critical injuries of acute radiation exposure and trauma. Clinicians will be responsible for providing care and information to both the injured and the concerned public and will need a way to prioritize treatment and care.
REDI-Dx fulfills this critical unmet need for high throughput radiation biodosimetry testing. REDI-Dx is designed to measure an individual’s biological response to radiation and provides an estimate of absorbed radiation from a peripheral blood sample. This absorbed radiation estimate, in conjunction with clinical signs and symptoms, as well as radiation dispersal monitoring, may help physicians identify and prioritize the highly and moderately exposed who need immediate treatment.
The REDI-Dx® Biodosimetry Test System
The REDI-Dx Biodosimetry Test System consists of the REDI-Dx Test Reagent Kits, the DxCollect® Blood Collection Tube (BCT), the Applied Biosystems® 3500xL Dx Genetic Analyzer, and REDI-Dx Interpretive Software.
After collection using the DxCollect BCT, the samples would be transported to testing labs at ambient temperature. The DxCollect® solution preserves the nucleic acids within blood allowing for stability up to 14 days. Upon delivery, the lab would test the samples with standard molecular testing equipment. Final analysis is performed on the ABI 3500 Dx Genetic Analyzer instrument, with results generated by REDI-Dx Interpretive Software.
REDI-Dx is CE-IVD Marked.
Not for sale in the USA. Limited by United States law to investigational use only.
19500 S. Rancho Way, Ste. 116,
001 (310) 537-7857