SBIR-STTR Award

Direct to Phase II

Leading to over 270,000 deaths in the US annually, septicemia is the systemic inflammatory response to a bloodstream infection (BSI). Studies have shown that early detection and the administration of appropriate antimicrobial treatment for BSIs are crucial for proper patient management and lead to improved patient outcomes and reduced hospitalization times. However, the current diagnostic standard of care relies on blood culture, which is not only slow, requiring ~1-3 days to return a positive result, but also demonstrates reduced sensitivity in the presence of antimicrobial treatment. Consequently, there is a substantial demand for innovative diagnostic approaches that eliminate the need for blood culture and deliver faster and more accurate results. To address this unmet need, HelixBind developed RaPID/BSI, a fully automated sample-to-answer test which identifies BSIs directly from blood in four hours, without cultures. Implemented on the RaPID (Resistance and Pathogen IDentification) platform and appropriate for placement throughout the hospital, RaPID/BSI incorporates a broad test menu of 20 bacterial and fungal pathogens and, crucially, is not compromised by prior antimicrobial treatment. Species level detail is provided with single CFUs/ml sensitivity, enabling selection of appropriate antimicrobials. Commercialization of RaPID/BSI will provide timely characterization of BSIs, enabling intervention with targeted antimicrobials. This is expected to result in improved patient outcomes and a reduction in the use of unnecessary antimicrobials, slowing the rise of antimicrobial resistance. Reflecting RaPID/BSI's significant advantages over exiting diagnostic standards and the potential to markedly improve care and quality of life, the FDA designated RaPID/BSI a Breakthrough Technology. In this proposed Phase II project, HelixBind will complete verification and validation activities necessary to prepare our submission to the FDA for regulatory clearance. This work includes improvements to the external control material to be provided with the system along with completion of analytical and clinical studies, as reviewed with the FDA. Upon successful completion of this project, we will file for regulatory clearance for RaPID/BSI and bring this breakthrough device to market.

Public Health Relevance Statement:
NARRATIVE Sepsis, the body's response to a bloodstream infection, is one of the leading causes of death and most expensive conditions to treat in US hospitals. Timely administration of appropriate antimicrobials is critical for improving patient outcomes. However, current diagnostics for identifying the infection, necessary for selection of the appropriate antimicrobials, require days to provide results and may fail to detect mixed infections or infection in patients on antimicrobials. This Direct-to-Phase II proposal is aimed at verifying and validating an automated, culture-free assay to identify bloodstream infections direct from blood in only a few hours. Successful completion of the proposed work will provide data necessary for a filing for FDA clearance of this novel device. Terms: