Automated system for the direct from blood characterization of bloodstream infections

About This Grant

PROJECT SUMMARY Septicemia, a systemic inflammatory response to bloodstream infections (BSIs), contributes to over 270,000 deaths annually in the US. Studies have shown that timely and accurate identification of an infection leading to the administration of appropriate antimicrobial treatment is critical for improved patient outcomes and reduced hospitalization times. However current standard-of-care (SoC) diagnostics, relying on blood culture, often require days for results and exhibit reduced sensitivity in the presence of antimicrobials, a common scenario in at-risk patients. This creates a critical unmet need for innovative diagnostics that are independent of cultures. HelixBind has developed a sample-to-answer molecular assay incorporating a suite of proprietary technologies, from sample preparation to detection, capable of characterizing BSIs directly from whole blood within ~4 hours. The assay leverages technological advances in sample preparation, supporting centrifugation- and filtration-free processing of multiple mLs of human specimen, while uniquely assaying only viable microorganisms present in the specimen. The assay also features target DNA sequence interrogation via a novel synthetic, dsDNA invading nucleic acid, demonstrating single-bp specificity as required to reliably differentiate between closely related species while effectively eliminating false-positives due to contaminations. In support of this proposal, we have completed assay development for a test menu representing 98% of infections as well as commonly encountered AMR genes and demonstrated single CFUs/mL sensitivity across its broad menu. We have subsequently successfully automated the entire sample-to-answer process onto a breadboard, bench-top, instrument which operates a disposable plastic consumable. This project will advance our platform to a hospital-ready alpha version. We will incorporate variable sample volume processing, essential for neonatal/infant and other vulnerable populations, and implement a novel internal control strategy for comprehensive, end-to-end assay validation. A hospital-based study testing specimens collected from patients will verify system performance. Successful completion of these project aims will position HelixBind to scale manufacturing and commence Analytical and Clinical studies for regulatory clearance. This project is a key step bringing this groundbreaking diagnostic platform to market.