A point of need clinical chemistry and hematology platform for improving accessibility to diagnostic testing

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PROJECT SUMMARY Complete blood counts and a basic metabolic panel are the most ordered blood tests in nearly all clinical settings. These tests are predominantly conducted on expensive high-throughput instrumentation in centralized or well- equipped satellite laboratories. Currently, there is no cost-effective and efficient instrumentation that can conduct these tests at the point-of-need or in clinics that do not have access to centralized testing facilities. The development of clinical instruments that can increase access to testing and provide clinicians with earlier, actionable diagnostic tests results have significant potential to improve healthcare management in a variety of clinical settings including rural and low resource settings, pediatric and neonate testing, and urgent and primary care settings. Critically, in many of these settings, healthcare personnel can be limited. In these settings phlebotomists or other trained personnel required for blood draws and clinical testing are not typically present. Consequently, there is a need for diagnostic testing instrumentation that can improve the accessibility of testing in various healthcare settings. Critically, this instrumentation requires ease of use, including CLIA waiver status, while providing performance that is comparable to standard testing in centralized laboratory settings. However, there are no solutions available that meet this need. To address this need, General Fluidics has developed the Axess System, which is a unique, rapid, cost-effective, and high-performance point-of-need solution that combines comprehensive clinical chemistry and hematology testing into a single modular platform delivering results in 15 to 20 minutes. The Axess system has been validated with venous whole blood for hematology and plasma derived from venous blood for clinical chemistry testing. In this proposal, the Axess system will be validated using fingerstick (i.e., capillary blood), where performance equivalence with venous blood would support use of the Axess systems in clinical settings where phlebotomists are not present. This would support further optimization and commercialization of the Axess system with a FDA CLIA waiver, which would deliver the first comprehensive instrument with central laboratory performance that could be used at the point-of-need. General Fluidics has previously validated a basic metabolic panel and a complete blood count through clinical performance evaluation studies at Massachusetts General Hospital and in-house evaluations. The goal of this Phase I project will be to demonstrate equivalence for hematology and clinical chemistry testing that is performed on the Axess System with de-identified matched capillary and venous blood specimens.