There is extraordinary need for a universal biomedical analyzer that has broadly flexible capabilities for diverse biomedical analysis. The goal of our rhealth x device is to create a single…

This is a $1,999,994.00 Small Business Innovation Research (SBIR) Phase III contract awarded by the National Aeronautics and Space Administration (NASA) to The DNA Medicine Institute, Inc. for the development of the RHealth X, a universal biomedical analyzer device. The goal is to create a single palm-sized device capable of diverse biomedical analysis tasks such as cell cytometry, vitals monitoring, and multiplex nanostrip tests. This contract supports the further development and FDA 510(k) clearance of a specific biomedical test for the RHealth X, which has applications for both space and terrestrial healthcare. The RHealth X is intended to provide comprehensive capabilities across hematology, chemistry, small and large molecules, and biomarkers, addressing a current gap in the market. This contract is part of NASA's Civilian Commercial Reimbursable Payloads Program (CCRPP) and involves additional funding from a biotechnology partner, XPRIZE, and a private investor.

There is extraordinary need for a universal biomedical analyzer that has broadly flexible capabilities for diverse biomedical analysis. The goal of our rhealth x device is to create a single palm-sized device that is capable of cell cytometry measurements and multiplexed nanostrip tests across diverse assay classes. IT works in concert with our skye sensor, a monolithic palm-sized unit for monitoring of all vitals, and chas, an intelligent APP. Currently, there is no single device that is able to provide comprehensive capabilities across hematology, chemistry, small molecules, large molecules, biomarkers assays, and vitals. Under this ccrpp effort, we will focus on a specific biomedical test and bring IT to the point where IT can be submitted for FDA 510K clearance. This will be accomplished with funds from a large biotechnology partner, xprize, a private investor, and matching funds from NASA s ccrpp program. The workplan includes several phases with design reviews including that encompass design inputs, detailed design, verification & validation, and transfer of units to our partner for clinical testing. Data from this testing will be utilized to submit for FDA 510K clearance. Successful demonstration of the technology in this manner means that the rhealth x will attain a TRL = 8 and MRL = 8 and be ready for commercialization in a manner that has implications for space and terrestrial applications. The rhealth x will aid crew members on the ISS and for travel to mars. Capabilities allow for rapid monitoring of critical and emergent conditions that may affect the health and safety of crew members. We envision the rhealth x will broadly advance healthcare diagnosis and democratize healthcare in a variety of settings for healthcare providers as well as consumers.