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Yes, physicians may continue placing orders for FMT preparations to treat patients with C. difficile infections not responsive to standard therapies.  

OpenBiome will operate normally and continue to distribute FMT preparations to physicians treating C. difficile infections not responsive to standard therapies.

OpenBiome operates under FDA oversight and maintains an Investigational New Drug (IND) Application that is kept current in accordance with regulations and guidelines. 

We and our partner, the University of Minnesota (UMN) Microbiota Therapeutics Program, are working with FDA to ensure that our regulatory filings are consistent with recently finalized guidance. 

FMT material distributed by OpenBiome has been manufactured in accordance with current Good Manufacturing Practice (cGMP) regulations. Stool donors undergo regular and rigorous screening for infectious agents and health risks to patients including SARS-CoV-2 and Monkeypox. Donated stool is directly tested for enteric pathogens and multi drug-resistant organisms including VRE, MRSA, ESBL, and CRE. More comprehensive information can be found in Investigator’s Brochures that are available upon request. 

Returning clinical partners will need to fill out a new registration form, which will be processed in a few days by OpenBiome. Once registration is complete, partners are free to start ordering. Shipping and handling procedures of FMT material from OpenBiome are largely the same so restarting your institute's FMT program should be relatively simple.