By Liz Hollis, Staff Writer
Day Zero Diagnostics Inc. has reported that data presented at IDWeek highlighted the promise of the company’s new class of diagnostics as it works toward its goal of detecting superbug infections quickly. The company ultimately is hoping to get regulatory signoffs in both the U.S. and Europe for its technology.
Boston-based Day Zero is developing a diagnostic system that aims to help patients with severe infections receive the most effective antibiotic treatment on the first day they are admitted to the hospital.
It is designed to enrich and extract bacterial DNA directly from a patient sample for sequencing, without the need for a time-consuming culture. It also has developed a machine-learning algorithm that analyzes the genomic data to identify the pathogen and determine its antibiotic susceptibility and resistance profile within hours.
Against that backdrop, researchers revealed interim results from the Boston Medical Center Rapid Bacterial Identification Trial that showed that Day Zero’s culture-free assay for determining the presence of a bacterial infection and its species were concordant with clinical blood cultures in 96% of samples. In addition, the results indicated that Day Zero’s assay is potentially more sensitive than culture-based diagnostics.
Also of note, Day Zero has had no false-positive results to date.
Nina Lin, assistant professor at Boston University School of Medicine and director of the Boston University Infectious Disease Clinical Research Unit, presented the results and acknowledged that they were early. With that said, they pointed to the promise of identifying bacterial pathogens without a culture. “Current culture-based diagnostics have slow turnaround times and low sensitivity,” she noted, adding that clinicians have been forced to rely on broad-spectrum antibiotics. Doing so has produced poor outcomes and contributed to the rise of antibiotic resistance.
“This new approach is promising because it provides clinicians with rapid and precise information that is essential for treating patients with targeted therapies,” Lin emphasized.
IDWeek also featured the presentation of results from a separate validation study of Blood2Bac, which was assessed in its ability to recover the whole genomes of pathogens. It was tested across 50 bacterial species spiked into whole blood at concentrations as low as 1 colony- forming unit per milliliter/mL.
Results demonstrated that Blood2Bac, when paired with Keynome, was able to achieve an average of 95% whole-genome coverage and correctly identify all 50 species with 100% accuracy even at single-digit bacterial concentrations.
“We’ve spent the last few years developing the core technologies necessary to make bacterial whole genome sequencing directly from blood feasible for clinical decision-making,” Jong Lee,