A Culture-Free Platform for Rapid Fungal Pathogen Identification - PROJECT SUMMARY Septicemia is a serious, life-threatening systemic inflammatory response to a bloodstream infection (BSI). Of particular concern are BSIs caused by fungal pathogens (fungemia) which affects over 100,000 Americans annually and is characterized by exceedingly high mortality rates (~40%). The optimal strategy to combat these infections is well known; immediate administration of appropriate antifungals. Due to their high cost and serious side-effects, though, antifungals are generally withheld until confirmation of infection. Unfortunately, standard techniques for confirmation still rely on antiquated blood cultures, which requires 1-3 days or longer leading to poor outcomes. More poignantly, it is estimated that 30% of fungemia patients never receive appropriate care, as diagnosis was only confirmed post-mortem. It is therefore critical to advance new diagnostic approaches, which do not rely on culturing, to rapidly transition to personalized antimicrobial interventions. To address this unmet need, HelixBind has developed RaPID/F, a test which characterizes fungal BSIs, directly from blood in ~2.5 hours, without cultures. Implemented on the RaPID (Resistance and Pathogen IDentification) platform, appropriate for placement anywhere in the hospital, RaPID/F detects (and discriminates between) both fungal and bacterial bloodstream infections. Species level detail is provided along with single CFUs/ml sensitivity for the most common Candida infections, enabling selection of appropriate antimicrobials. The test menu also includes Candida auris, an emerging multi-drug resistant pathogen considered a global health threat. Importantly, RaPID/F can be used not only for detection of C. auris in blood, but also on surfaces or instruments – addressing an urgent need to control hospital outbreaks of this deadly pathogen. Combined, RaPID/F not only enables the confirmation of fungemia days faster than currently possible by standard techniques, but also addresses use cases identified by customers as crucial to drive adoption. HelixBind has met and exceeded each of the Specific Aims defined in the Phase II NIAID SBIR. This included verification of the test menu, incorporating five key Candida species and an Internal Control, to which we added coverage of additional pathogens, automation of this test onto a single-use plastic disposable, and demonstration of >90% sensitivity and 95% specificity with clinical samples as well as a subset spiked at clinically relevant loads. Given the success of this Phase II work, HelixBind proposes in this Phase IIB to advance RaPID/F toward readiness for regulatory clearance. Specific Aims proposed, each with quantifiable deliverables, serve to address and de-risk manufacturing, usability, and analytical and clinical performance aspects of the product. This proposed Phase IIB will culminate in a blinded, in-hospital, study challenging our proposed FDA pivotal study design. Upon completion of this project, we will be well placed to initiate formal Analytical and Clinical studies for FDA clearance of RaPID/F and scale manufacturing for product launch.
