Fecal microbiota transplants (FMT) are remarkably effective treatment options for recurrent C. diff infections. However, a series of recent FDA safety alerts in 2019 and 2020 highlight the potentially serious risks associated with the procedure, namely the risk of transmission of pathogenic bacteria from donor to patient. Day Zero works with clinicians and industry leaders to investigate transmission events related to FMTs using epiXact®, our whole genome sequencing and analysis service for transmission determination and inform policies to enhance the safety of this remarkable procedure.

In 2019, the New England Journal of Medicine published an article titled “Drug-Resistant E. coli Bacteremia Transmitted by Fecal Microbiota Transplant” in which the epiXact service was used to rapidly determine that isolates from patient blood samples and a donor stool sample were clonal using single nucleotide polymorphism (SNP) comparisons of the whole genomes. Our epiXact team served as co-authors on the paper which highlighted the importance of donor screening. The results of the investigation led FDA to issue a national safety alert recommending new donor screening and testing procedures.

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This past month, Clinical Infectious Diseases published a new study in which a leading national stool bank requested Day Zero’s assistance to investigate an FMT transmission event. In this study, adverse events were reported in 7 patients who received FMTs linked to a stool donor colonized with Shiga toxin-producing Escherichia coli (STEC), despite the material being screened for STEC using an enzyme immunoassay. In consultation with FDA, the stool bank implemented prospective PCR testing to enhance patient safety, and FDA now recommends that all donor material used for FMT be tested by nucleic acid methods for STEC.

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Whole-genome sequencing is playing an increasingly important and prevalent role in investigations to rule-out or rule-in healthcare-associated infection transmission events. Day Zero’s epiXact® service enables all healthcare providers to access this capability easily and cost-effectively. Want to learn more? Contact our world-class team of scientists to answer your questions or request an epiXact investigation.