NIH grant: Automated system for the direct from blood characterization of bloodstream infections (1R44AI197309-01)

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NIH grant 1R44AI197309-01: Automated system for the direct from blood characterization of bloodstream infections
Institute: {'code': 'AI', 'abbreviation': 'NIAID', 'name': 'National Institute of Allergy and Infectious Diseases', 'admin_org_id': '12500003', 'admin_funding_url': ''}. PI: Alon  Singer. Award: $1029859.
Start: 2026-07-16T00:00:00.
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.

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