Commercializing nanodroplet technology to improve diagnostic sensitivity for difficult-to-lyse microbial samples

The National Institute of Allergy and Infectious Diseases awarded Triangle Biotechnology, Inc. one million dollars on July 20, 2026, under the Allergy and Infectious Diseases Research program (CFDA 93.855) to commercialize nanodroplet technology for improved microbial lysis and DNA extraction from difficult-to-lyse samples.

Triangle Biotechnology is developing SnapLyse, a proprietary cavitation-enhancing nanodroplet reagent paired with low-power sonication for efficient, high-throughput, and reproducible microbial lysis. The technology addresses the clinical limitation of traditional chemical, enzymatic, and bead-beating extraction methods that yield poor results from samples containing microbes with thick, resilient cell walls. SnapLyse incorporates pre-formed cavitation nuclei and targeting ligands that bind to microbial cell surfaces to deliver mechanical force, enabling DNA extraction from low cell concentrations and unbiased extraction from microbiome community samples. The company has demonstrated the technology's application to improve culture-free, targeted next-generation sequencing for identification of drug-resistant Mycobacterium tuberculosis.

The award funds development through June 30, 2029, with performance in Chapel Hill, North Carolina. Triangle Biotechnology, a for-profit biotechnology company, has received multiple prior NIH awards totaling over three million dollars supporting development and optimization of its nanodroplet technologies for nucleic acid extraction and antimicrobial resistance marker identification.

Abstract

Triangle biotechnology is developing snaplyse™, a novel and proprietary technology for efficient, high- throughput, reproducible, and unbiased microbial lysis, based on a cavitation-enhancing nanodroplet reagent for use with low-power sonication devices. Efficient DNA extraction is required for successful and accurate identification of microorganisms or populations of microbes using nucleic acid testing (NAT) and next-generation sequencing (NGS) methods. Microbes with thick and resilient cell walls are particularly difficult to lyse using traditional chemical, enzymatic, and bead-beating based techniques. Poor DNA extraction from clinical and environmental samples containing resilient microbes lead to inconclusive or inaccurate diagnostic results. The current solution to this problem is primary culturing to isolate microbial strains for DNA extraction; however, culturing is economically and logistically unsustainable and presents with biological issues that confound results. Triangle BIO's nanodroplet technology will address the clinical need for improvement in lysis and extraction methods from direct samples for NGS-based diagnostics and characterization of infectious diseases. This technology incorporates pre-formed cavitation nuclei requiring low levels of acoustic energy to release localized shockwave- and microstream-generated mechanical forces. Snaplyse nanodroplets incorporate a targeting ligand that binds to the microbial cell surface to deliver mechanical force to the pathogen. This design enables DNA extraction from low cell concentrations, and unbiased extraction from microbiome community samples. Snaplyse was used to improve the efficacy of culture-free, targeted next-generation sequencing for the identification of drug-resistant mycobacterium tuberculosis (DR-MTB); a MTB-specific snaplyse formulation was developed and was shown to improve the culture-free detection of DR-MTB. This commercialization readiness program project will advance triangle's platform through the following specific aims: 1. Optimize workflows for use with sputum, saliva, and stool, ensuring robust DNA extraction across diverse sample types and integrate with genoscreen deeplex MYC-TB and ampore-TB assays to provide a complete end to end diagnostic pipeline for MTB; 2. Manufacturing scale-up and cost-optimization in preparation for commercial launch; and 3. Independent third-party clinical validation by rapid research in diagnostics development for MTB (R2D2 TB) and preparation for FDA regulatory submission for snaplyse.