Daxor proposes to create a non-nuclear fluorescent blood volume quantification capability compatible both with DaxorÂ’s commercially available Blood Volume Analyzer (BVA), the BVA-100, and later with the ruggedized BVA-200 system currently under development. This dual-use or military and civilian Fluorescent BVA-200 (BVA-200F) capability will be achieved by replacing the current I131 nuclear tracer quantification with the quantification of a fluorescent alternative, and innovating components of the device to handle the characteristics of new non-nuclear tracers. The presence of radiation and relatively complex and lengthy test procedures challenge the use of current BVA technology in broader military settings, including en route care. Both a Clinical Laboratory Improvement Amendments (CLIA) and Radioactive Materials License (RAML) accreditation are required to perform BVA; the administration of the I-131 HSA tracer dose is limited to just eight tests per week because of patient radiation exposure levels. In addition, the test is performed by nuclear medicine technicians with nuclear medicine laboratory processing. All of these factors constitute substantial challenges for using BV analysis in military settings. The planned technological innovations (subject to change based on DoD end user feedback in Phase I) for this Phase II SBIR application include development of fluorescent tracer and sensing technology, and the integration of this technology into a handheld device which will be ready for manufacture and regulatory submission. The Phase II deliverable will be a BVA-200F prototype possessing the gold standard accuracy and reproducibility of BVA-100, as well as the enhanced safety, increased access, ease of use, and increased frequency of testing afforded with the use of non-nuclear indicator dilution methodology.
