Automated Multiplex Analyzer for Sepsis and Beyond

Project Summary/Abstract The current paradigm of monitoring various blood parameters in critical care are manual, labor intensive, infrequent, and prone to inaccuracies while wasting so much blood as to cause anemia in patients with prolonged ICU stays. There is a well-established clinical need for frequent monitoring of blood parameters in critical care settings to support early identification and therapeutic management for a range of conditions such as sepsis, shock, acidosis, uncontrolled glycemia, and traumatic injuries. For instance, early diagnosis and management of sepsis and acidosis, through timely lactate measurements supported by additional parameters like glucose and hematocrit enables rapid intervention that reduces mortality. Appropriately timed glucose measurements are essential for achieving tight glycemic control in critical care settings, while frequent hematocrit monitoring guides transfusion therapy for patients with traumatic injuries. Through an NIH SBIR Phase I award, Cascade Metrix (CMX) developed and validated a patient-connected automated multiplex analyzer (AutoPlexer) whose initial embodiment provides pre-programmed or on-demand measurement of lactate, glucose and hematocrit in whole blood using a central venous catheter. The AutoPlexer’s automated blood sampling and measurement performance was validated in preclinical studies using porcine models. Notably, no blood is lost by the subject, nor is there a need to infuse anticoagulants such as heparin. The automation and trending information provided by the AutoPlexer’s simultaneous measurement of multiple analytes is expected to significantly improve patient outcomes by enabling both early diagnosis and precise ongoing therapeutic management. In this Phase II project, the current AutoPlexer basic platform will be refined and validated for first-in-human studies and its measurement capabilities will be expanded to include additional parameters to enhance market traction following the introduction of the 3-analyte version. These parameters include: venous oxygen saturation, creatinine, plasma volume status, pH, pyruvate, glutamine, as well as other biomarkers. Ultimately, the AutoPlexer will stream its measurement data into AI/ML and workflow tools that support glycemic control, sepsis management and the like. SBIR Phase II funding will be combined with private equity funding to obtain FDA 510k regulatory approval and launch of the 3-analyte AutoPlexer for early adoption in critical care. As further sensor technologies are developed and incorporated into the AutoPlexer platform, FDA approval will be sought using the 3-analyte system as the predicate. The introduction of these analytes and any newly emerging biomarkers into the measurement suite of AutoPlexer will deepen coverage of wide-ranging acute pathologies encountered in critical care and enhance traction.