# A Culture-Free Platform for Rapid Fungal Pathogen Identification

> **NIH NIH R44** · HELIXBIND, INC. · 2022 · $1,000,000

## Abstract

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 ...

## Key facts

- **NIH application ID:** 10374805
- **Project number:** 5R44AI109913-06
- **Recipient organization:** HELIXBIND, INC.
- **Principal Investigator:** Alon Singer
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2014-08-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10374805

## Citation

> US National Institutes of Health, RePORTER application 10374805, A Culture-Free Platform for Rapid Fungal Pathogen Identification (5R44AI109913-06). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10374805. Licensed CC0.

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