DZD Awarded SBIR Grant for Development of Microbiome Diagnostics

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Aug 29, 2023, 08:00 ET

SBIR Phase I funding supports development of a new pharmacovigilance assay to support fecal microbiota transplantations.

BOSTON, Aug. 29, 2023 /PRNewswire/ -- Day Zero Diagnostics (DZD) Inc., a pioneer in infectious disease diagnostics, has received a Phase I Small Business Innovation Research (SBIR) award from the National Institute of Allergies and Infectious Disease (NIAID) of the National Institutes of Health (NIH). The award funds the development of epiXact^® FMT, a pharmacovigilance assay to enhance safety and efficacy in fecal microbiota transplant (FMT) clinical trials.

FMT, a groundbreaking therapy, transfers beneficial microbial communities from healthy donors to patients' gastrointestinal tracts. It is a recently approved treatment for recurrent Clostridium difficile infections (CDI), backed by extensive clinical research. Despite stringent donor screening, recent cases revealed potential pathogen transmission. In a 2019 New England Journal of Medicine article, DZD's epiXact^® revealed that pathogenic bacteria was passed from donor to patient through high resolution genomic analysis of complex samples, confirming a patient's death due to FMT treatment and prompting an FDA safety alert.

"Microbiota transplant safety relies on rigorous donor screening and swift transmission detection," said Dr. Mohamad Sater, DZD's Director of Computational Biology and the project's principal investigator. "We're developing an advanced pipeline for accurate strain detection in complex metagenomic samples, validated in prior collaborations. This approach will be pivotal in future clinical studies, ensuring patient safety and advancing personalized medicine."

"We are honored to receive this NIH grant, which underscores our commitment to reshaping the landscape of infectious disease diagnostics and infection control using whole genome sequencing and machine learning," said Jong Lee, CEO and Co-founder of DZD. "With the support of this award, we are continuing to expand our epiXact^® suite of services focused on healthcare-associated infection (HAI) outbreaks and transmission events."

The SBIR grant is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number 1R43AI179293-01. The content of this release is the responsibility of Day Zero Diagnostics and does not necessarily represent the official views of the National Institutes of Health.

About Day Zero Diagnostics

Day Zero Diagnostics, Inc., based in Boston, is pioneering a new class of infectious disease diagnostics using whole-genome sequencing and machine learning to revolutionize how the world fights the growing threat of antibiotic resistance. The company's mission is to change the way infectious diseases are diagnosed and treated by rapidly identifying both the species and the antibiotic resistance profile of severe infections from a clinical sample directly, without the need for a culture. Day Zero also offers various WGS-based lab services, leveraging its proprietary technologies and highly curated databases of pathogens for managing healthcare-associated infection outbreaks and making high-impact clinical decisions. Day Zero Diagnostics was founded in 2016 by a team of clinicians and scientists from Harvard University and Massachusetts General Hospital. The company has been recognized as a leading innovator by CARB-X, UCSF Health, American Association of Clinical Chemistry, MedTech Innovator, TedMed Hive, Xconomy, HealthTech Arkansas, and MassChallenge HealthTech. Follow DZD on Twitter and LinkedIn.

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