OpenBiome will continue distributing UMN-manufactured investigational FMT for patients suffering from recurrent C. difficile (rCDI) not responding to standard therapies. To access this material, a new registration form must be completed. This applies to all sites, even if you have an existing OpenBiome agreement.
Emergency Access Restriction Lifted: OpenBiome’s partnership with UMN has enabled us to lift the ‘emergency only’ shipping policy that was in place since August 2021. If you have patients that are eligible for an investigational FMT to treat rCDI, you may place an order without applying for emergency access.
Plans to Expand On-hand Inventory: As we have ramped up operations, we expanded access by allowing sites to maintain on-hand inventory. Partner sites can now maintain an inventory of up to 5 units of investigational FMT.