BARDA is continuing its partnership with ASELL to develop fieldable diagnostics to rapidly identify individual exposures to ionizing radiation following a nuclear or radiological incident. Rapid triaging of casualties is a key component of the public health and medical response to guide treatment, preserve scarce resources, and alleviate public concern. Currently, no diagnostic tool is available to quickly identify persons that need acute medical care following an ionizing radiation incident.

Through this partnership, BARDA is providing funding to develop three related products: the Prospector Point-of-Care complete blood cell counts (CBC) analyzer developed by ASELL’s partner Alentic Microscience, the CellRADx biodosimetry software which is being developed as a Software as a Medical Device (SaMD) application, and the CellRADx Instrument which combines the first two into an integrated biodosimetry device. If successfully developed, these tools could enhance and expand emergency medical response and first responders’ capabilities to determine complete blood cell counts (CBC) quickly and reliably in triage settings. That information can be used to identify individuals who have absorbed levels of radiation requiring emergency clinical management.

• Alentic’s Prospector CBC analyzer is expected to be a CLIA-waived, portable, fast, rugged, reliable hematology analyzer capable of providing complete blood cell counts from finger-stick blood by minimally trained operators directly in the field and at points-of-care. Its lensless microscopy technology provides complex laboratory-grade CBC analysis, including differentiation and simultaneous identification of the five major white blood cell types in blood (neutrophils, lymphocytes, monocytes, basophils and eosinophils).
• CellRADx Software will be a standalone Software as a Medical Device (SaMD) diagnostic application that uses hematological data and biodosimetry algorithms to provide early diagnostic information for the initial management of radiation casualties. The CellRADx Software is based upon an algorithm developed in collaboration with the Armed Forces Radiobiology Research Institute (AFRRI) and licensed through the Henry M. Jackson Foundation for the Advancement of Military Medicine.
• CellRADx Instrument will integrate both technologies into a self-contained, rapid and easy-to-use POC biodosimetry diagnostic device that, from a single drop of blood and in less than 10 minutes, can identify individuals that absorbed significant radiation doses and are in need of immediate medical care.

Each of these three products is intended to aid in emergency preparedness and complex crisis management by providing rapid and easy-to-use tools for mass screening, effective triage of exposed victims and reassurance to the unexposed yet concerned population.

This award is one component of the BARDA’s DDDI and CBRN Division medical countermeasure portfolio. Visit the CBRN Portfolio and the DDDI webpage to learn more.