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New Class of Bloodstream Infection Diagnostics to Enable Culture-Free, Same-Day Organism Identification

By LabMedica International staff writers
Posted on 21 Nov 2023

The World Health Organization reports that sepsis-related complications lead to 11 million deaths annually, making up a fifth of all global deaths. Sepsis, a severe infection, demands prompt and effective treatment as mortality risks escalate with each passing hour. Traditional culture-based diagnostic methods, which take days to identify pathogens and determine antimicrobial susceptibility, contribute to either excessive or insufficient treatment, particularly when antibiotic-resistant organisms are involved. This situation underscores the urgent need for rapid diagnostic technologies capable of identifying pathogens and providing antimicrobial susceptibility results within hours, thus guiding effective therapy.

Oxford Nanopore (Oxford, UK) and Day Zero Diagnostics (Boston, MA, USA) have entered into a collaboration to develop a comprehensive diagnostic solution for bloodstream infections, a major cause of sepsis. This collaboration will seek to develop a diagnostic system that offers same-day pathogen identification and genomic-based antibiotic susceptibility profiles without the need for blood cultures. Both companies aim to streamline this system for clinical environments, such as hospitals, and plan to pursue regulatory approvals, including clearance from the FDA, in the future.

Image: Keynome ID is a proprietary algorithm that classifies the bacterial species present in a sample (Photo courtesy of Day Zero Diagnostics)
Image: Keynome ID is a proprietary algorithm that classifies the bacterial species present in a sample (Photo courtesy of Day Zero Diagnostics)

This innovative diagnostic system will combine Day Zero Diagnostics’ advanced sample preparation technology, which highly enriches samples, with its AI-powered Keynome technology. Keynome is adept at identifying microbes and determining antibiotic susceptibility. This system will be paired with sequencing data from Oxford Nanopore's PromethION 2 Solo, a high-throughput, compact sequencing device. The partnership is focused on creating an automated workflow for sample processing and sequencing that is tailored to the operational demands of clinical hospital laboratories. The PromethION 2 Solo platform from Oxford Nanopore, recognized for its real-time capabilities, scalability, and improved accuracy in single-nucleotide sequencing, is an ideal fit for the rapid and cost-efficient identification of pathogens directly from clinical samples.

"We are pleased to launch this collaboration with Oxford Nanopore that integrates nanopore sequencing innovations with Day Zero Diagnostics' platform technologies to develop a first-of-its kind diagnostic solution for sepsis," said Jong Lee, CEO and co-founder of Day Zero Diagnostics. "Culture free, same day, organism identification and antimicrobial susceptibility profiling directly from native samples will be a game changer for infectious disease diagnostics, directly enabling early, targeted life-saving treatment for patients."

"We are excited to partner with Day Zero Diagnostics to bring the benefits of nanopore sequencing to fight bloodstream infections," said Gordon Sanghera, CEO of Oxford Nanopore Technologies. "Our hope is that the rapid results, high accuracy and accessibility of the Oxford Nanopore system, combined with DZD's expertise and workflow, will make it possible for more people to access a solution that's fast and effective in the fight against bloodstream infections."

Related Links:
Oxford Nanopore
Day Zero Diagnostics

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