Bloodstream infection detection directly on whole blood

Bloodstream infection detection directly on whole blood Summary Yeast bloodstream infections are life-threatening, affecting approximately 50,000 patients annually in the United States, with mortality rates exceeding 40%. Early administration of antifungal therapy is critical for improving survival rates. However, the current diagnostic gold standard, blood culture (BC), requires one to five days, delaying crucial treatment decisions. To address this gap, Scanogen has developed an automated platform for the rapid, comprehensive, and cost-effective identification of yeast in whole blood without the need for BC. This platform is powered by Single MOLecule Scanning (SMOLT), an innovative method for sample preparation and molecular detection. In this Commercialization Readiness Pilot (CRP) Program, we aim to build on the success of our SBIR Phase II project, where we achieved or surpassed all milestones. During this phase, we developed, automated, and clinically tested the SMOLT-Yeast assay. The assay has straightforward workflow: the user inserts the patient’s blood sample, collected in a vacutainer, into a disposable cartridge, which is then analyzed by a desktop instrument. The assay demonstrated exceptional performance, with a detection limit of 1 CFU/mL across 11 yeast species, a clinical sensitivity of 96.7%, and a clinical specificity of 99.8%. Following stakeholder recommendations, we also included Candida auris in the test panel. In this CRP, we will focus on scaling production and meeting regulatory standards. Specifically, we will develop manufacturing processes for reagent production (Aim 1) and cartridge production (Aim 2) in compliance with FDA regulations. Additionally, we will enhance the instrument software by incorporating cybersecurity measures and Laboratory Information System (LIS) communication capabilities, and transfer the design to production (Aim 3). Our team comprises highly skilled assay development scientists responsible for the SMOLT technology and experienced engineers. This platform has the potential to greatly improve patient outcomes by delivering rapid and accurate results, allowing timely antifungal treatment for yeast bloodstream infections. Upon completion of this project, we will be positioned to initiate the pivotal analytical and clinical studies necessary for FDA clearance.