Human space exploration requires the development of medical devices and diagnostics for a more individualized and autonomous practice of medicine, in order to mitigate health risks and ensure…

This award is a grant from the National Aeronautics and Space Administration (NASA) to Imec USA Nanoelectronics Design Center, Inc., a non-profit research and development organization. The grant supports the testing and development of Imec's proprietary nanofluidic processor (NFP) technology, which is designed to enable gravity-independent, point-of-care medical diagnostics for space exploration. The goal is to demonstrate the NFP's ability to perform a complete blood cell count test in variable gravity conditions, as a precursor to evaluating the technology for use on future space missions. This grant, valued at $493,786.89, does not have a set-aside designation. Imec USA Nanoelectronics Design Center, Inc. is a subsidiary of the larger Imec organization, which has previously provided specialized neurotechnology products and research support to various U.S. federal agencies.

Human space exploration requires the development of medical devices and diagnostics for a more individualized and autonomous practice of medicine, in order to mitigate health risks and ensure performance and mission success. Deployable medical devices with minimal instrumentation are a priority. The goal in personalized medicine is to bring accurate and instantaneous actionable diagnostic testing at any point of need to enable faster and more efficient healthcare, and space medicine can benefit from incorporating those practices in space exploration missions. This proposal is centered on a proprietary technology based on a novel silicon chip concept called nanofluidic processor (NFP) that is embedded in a single-use, low-cost test card. The NFP fully passively controls a complete set of sample manipulations without the need of external actuation or instrumentation. This is possible since sample manipulations happen solely by means of capillary forces enabled by precisely manufactured geometric microstructures inside the silicon chip. As a consequence, the operation of the NFP can theoretically also take place in gravity-independent environments. Additionally, capabilities such as thermocycling for nucleic acid detection (e.g. useful for the detection of infectious diseases such as influenza) and optical waveguides for the detection of proteins and small molecules (e.g. useful for the monitoring of bone degradation or cardiac markers) can be integrated into the NFP to broaden the capabilities of the platform to a large percentage of analytes of diagnostic value measured nowadays on earth. After the sample is being processed by the NFP, these analytes are detected out by a compact, lightweight reader, similar to a credit card and its card reader. The NFP was originally developed by imec, the world-leading r & d center for nano electronics and digital technologies, and is now being further developed at the imec spin-off midiagnostics. Currently, the NFP has reached the stage of an integrated test card prototype (TRL4) that performs a complete cell blood count, or CBC with differential, from a drop of blood. A CBC test is one of the most frequently ordered tests by doctors, and provides relevant insights into an individual s health status. The following is a proposal for a plan to test the NFP system in an environment subjected to different gravitational loads, before final testing in low-earth orbit (LEO) on the international space station (ISS) at a later stage. As mentioned above, the proprietary microfluidic architecture of the NFP enables the distribution of sample and solutions in a gravity-independent manner, however, this has not been tested to date. Parabolic flight, with its associated gravitational fluctuations, is the ideal platform to test the robustness of the system. The length of the flight allows for sufficient time to operate several parallel and sequential runs, after which a solid proof-of-concept would be completed. The CBC test card is the first of a suite of diagnostics solutions intended for further consolidated biochemical and molecular diagnostics tests in point-of-care settings. This platform versatility is ideal for use in the vehicles and habitats venturing onto the moon and mars in the future. By testing the function of this first test card, the proof-of-concept for devices based on this technology will be achieved, therefore permitting their consideration for operational use in space medicine. In summary, while several microfluidic devices have been evaluated for applications in human spaceflight, this is the first silicon microfluidic platform of its kind (given IT is solely actuated by capillary forces), which may provide a true low mass/volume/power solution for the numerous diagnostics/bioanalytical needs to monitor crew health status. This addresses the need for technologies that support human operations and further commercial activity both in earth orbit and beyond in cislunar space.