This is a revised STTR Phase II Competing Continuation application to allow 3Ti to: produce a second- generation version of a fully-automated blood bank multianalyzer (the 3Ti AEGIS);evaluate the AEGIS in multicenter clinical trials;and submit an FDA 510(k) application. Developed through previous STTR support, the AEGIS performs rapid, accurate, and cost-effective blood typing and other pretransfusion testing with walk-away automation. Using Phase I funding, we initially developed a robust technology for blood typing by fluorescence cytometry. In Phase II, we leveraged this work to fabricate a fully-automated prototype (first-generation) which was thoroughly tested during in-house clinical trials. These evaluations demonstrated 3 significant advantages of the AEGIS over leading commercially available systems. First, and most importantly, the AEGIS performed blood typing with better clinical accuracy than competing technologies. Second, cost analysis demonstrated that this instrument was significantly less expensive to operate. Third, because our system was developed with a multifunctional architecture, we also showed (through separate Phase I STTR funding) that it could be readily configured to perform assays that have not previously been automated including counting residual WBCs after filtration of blood components and detecting anti-HLA antibodies in donor plasma (to prevent TRALI). While we believe that the advantages of the AEGIS device will make it very commercially competitive in the blood industry, the work proposed in this application is vital in order to allow 3Ti to pursue and obtain the required FDA 510k premarket approval.
The Specific Aims are as follows: 1) To fabricate 2 second-generation AEGIS workstations, and complete development and validation of AEGIS operating software and reagents;2) To perform multicenter clinical trials designed with FDA approval;and 3) To evaluate and incorporate the results of the clinical trials into a viable FDA 510(k) submission, with the objective of demonstrating substantial equivalence to predicate devices and obtaining approval to bring AEGIS to market. PULIC HEALTH RELEVENCE: Implications and relevance to public health: Red blood cell transfusions represent lifesaving therapies for anemic patients. Prior to transfusion, recipient and donor blood type must be determined, and crossmatching performed, to ensure compatibility. The 3Ti AEGIS is a completely automated blood typing workstation with significant advantages over current methodologies. We anticipate that commercialization of the AEGIS will reduce the incidence of incompatible transfusions and thus improve transfusion outcomes and patient safety.