Sepsis, one of the leading causes of death, occurs when the immune system’s response to an infection spirals out of control. This can cause organ failure and other internal damage, and even death. For patients in sepsis, time to diagnosis is critical. Getting appropriate treatment right away leads to survival rates of roughly 80%. But for each hour that treatment is delayed, mortality rates increase by approximately 8%. Conventional sepsis tests can take hours or even days to generate results - far too long for optimal patient care. They are also expensive and must be run by skilled technicians in a hospital laboratory. Patients in sepsis would fare better with rapid, point-of-care testing. Now, a 11-minute critical infection test for use with a mobile, hand-held analyzer gives healthcare professionals more comprehensive information to make a sepsis diagnosis.

Nanōmix, Inc.’s (San Leandro, CA, USA) eLab system is a rapid, easy-to-use, quantitative detection platform that performs a range of in vitro diagnostic assays. The platform consists of a hand-held analyzer and a disposable cartridge. The Nanōmix eLab system utilizes patented multi-plex test cartridge technology designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings. The analyzer utilizes a proprietary nano-biosensor with multiple detection electrodes to generate multiple electrochemical assay results from a single patient sample. The Nanomix eLab system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing.

Nanōmix’s first assays address the critical needs for faster diagnosis of critical infections as well as the rapid identification of current and prior SARS-CoV-2 infection. Nanōmix’s 11-minute critical infection test for use with its handheld eLab analyzer covers three key biomarkers - lactate, procalcitonin (PCT), and C-reactive protein (CRP). First responders and other providers can use the Nanomix test for quick, on-the-spot assessment and triage of patients no matter where they are. Information that previously took hours to get through confirmatory testing is now available to clinicians dealing with patients suffering complex and non-specific symptoms. In 2019 Nanomix received CE Mark for this test, which is undergoing FDA 510(k) review and is currently the only test for the procalcitonin marker that can be performed outside of a laboratory. Additionally, Nanomix has received the EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its eLab analyzer.

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