NEW YORK – Day Zero Diagnostics announced on Tuesday that it has been awarded a Phase I Small Business Innovation Research award from the National Institutes of Health's National Institute of Allergy and Infectious Diseases. The $299,989, one-year award will support development of a safety and efficacy assay for fecal microbiota transplants called epiXact FMT.
Boston-based DZD uses whole-genome sequencing and machine learning to develop tests for infectious diseases and antibiotic resistance.
Fecal microbiota transplant was recently approved by the US Food and Drug Administration for treatment of Clostridium difficile infections, but DZD previously used the epiXact platform's high-resolution genomic analysis to discover donor-derived pathogenic bacteria that caused one patient's death due to the treatment, resulting in an FDA safety alert.
There are currently no species-agnostic services to assess donor sample safety and assist in fecal microbiota transplant pharmacovigilance, according to DZD's NIH project abstract.
In a statement, Mohamad Sater, DZD's director of computational biology and the project's principal investigator, said that the firm is developing an advanced pipeline for accurate strain detection in complex metagenomic samples that was validated in prior collaborations.
"This approach will be pivotal in future clinical studies, ensuring patient safety and advancing personalized medicine," Sater said.