On June 13, FDA reported that an immunocompromised patient treated with FMT died from a drug resistant infection. Importantly, this patient was not treated by Finch or our collaborator, OpenBiome. The FDA has communicated new mandatory screening standards, which Finch already exceeds. As a result, there is no impact on Finch’s work and our PRISM 3 and PRISM-EXT studies continue uninterrupted.
The infection occurred in a high-risk patient that received material from a donor that was not screened for a common drug resistant pathogen, resulting in exposure and subsequent infection. Finch has a thorough screening program which incorporates a panel of 30+ laboratory tests, including the agent associated with this adverse event, as part of our commitment to patient safety.