OpenBiome Screening for SARS-CoV-2 virus and associated Coronavirus Disease 2019 (COVID-19)

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UPDATE APRIL 10, 2020:

  • OpenBiome is still shipping material; all material being shipped was collected and manufactured prior to December 1, 2019 and is compliant with all FDA guidance.

UPDATE MARCH 25, 2020:

  • There have been no reports of SARS-CoV-2 transmission by FMT.

  • No OpenBiome FMT material in circulation was collected or manufactured after December 1, 2019.

  • OpenBiome proactively implemented screening of all donors that includes molecular testing for SARS-Cov-2, and screening for COVID-19 risk factors and symptoms, and is compliant with all FDA guidance. Read below for additional details.

UPDATE MARCH 23, 2020:

No FMT material collected after December 1, 2019 will be shipped until it can be affirmatively cleared of COVID-19 risk. No material collected after December 1, 2019 has ever been shipped to partners; all remains in quarantine in OpenBiome’s freezers.

OpenBiome has proactively taken all necessary steps to comply with FDA instructions related to COVID-19, including today’s announcement.

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CAMBRIDGE, Mass—OpenBiome is carefully monitoring the spread and impact of the SARS-CoV-2 virus and the associated Coronavirus Disease 2019 (COVID-19) on its patients, stool donors, and staff. OpenBiome is specifically monitoring: (1) the spread of COVID-19 through the greater Boston area, where OpenBiome operates and collects stool; and (2) emerging research on the potential for COVID-19 transmission through stool.

No material in circulation was collected or manufactured after February 1, 2020, the first reported case in Massachusetts. We have implemented new screening measures for COVID-19, and will not ship out material collected or manufactured after February 1, 2020 until we can confirm it passes all relevant safety and quality standards.

OpenBiome has introduced thorough measures to screen donors for COVID-19 risk or carriage, even if they are asymptomatic, including regular nasopharyngeal swabs that will test for presence of the virus. See below for specific details. Our safety measures are continuously reviewed by our clinical team and Clinical Advisory Board, and, per our standard practice, all of our material remains quarantined until we can confirm it meets our safety and quality standards, including for COVID-19.

OpenBiome has implemented the following measures into its Quality and Safety Program to mitigate the risk of COVID-19: 

Please note, as this is an evolving situation, changes may occur; we will keep our partner network informed of any developments in our response as new data emerge.

  1. Donors are undergoing COVID-19 screening by nasopharyngeal swab at a minimum of every 30 days.

    • Donors testing positive will have their material destroyed from the 28 days prior to any positive test and will be placed on hold and excluded from providing donations for a minimum of 8 additional weeks.

  2. Donors are evaluated for travel, exposure to known or possible COVID-19 cases, and symptoms associated with COVID-19 at every stool sample collection.

    • Travel deferral:

    • Exposure:

      • Donors with exposure to proven or suspected cases of COVID-19 within the past 28 days will have material from the 28 days prior to exposure destroyed and will be placed on hold for a minimum of 28 additional days.

    • Symptoms:

      • Material collected in the 28 days prior to any onset of symptoms associated with COVID-19 is destroyed. Donors reporting any symptoms are placed on hold for a minimum of 28 additional days.

  3. All material remains quarantined until we can confirm it meets our safety and quality standards, including for COVID-19.

  4. To protect donors and staff from transmission of the virus, OpenBiome is restricting access to its facilities to essential on-site staff, vendors, and donors only, and is taking maximum steps to sanitize and disinfect all surfaces.

    • In addition to the normal practice of disinfecting bathrooms between donor use, surfaces in common areas—such as door handles, railings, light switches—are disinfected every hour with hospital-grade disinfectant.

    • Screening questions are placed at the donation site door and emailed to prospective donors, donors, and vendors.

    • All persons who wish to enter any OpenBiome facility must answer no to the following questions to gain entry:

      • Any symptoms or illness in the past 28 days

      • Exposure to known or suspected COVID-19 cases in the past 28 days

      • Travel to CDC risk level 1-3 countries in the past 28 days.

    • No visitors or other external persons are allowed in the building beyond those required for essential operational functions.

    • Beginning March 13, 2020, OpenBiome implemented a work-from-home policy. Staff who are not essential for on-site tasks are working remotely. This policy is designed to minimize health risks to essential on-site staff who are critical to continuing the acceptance, manufacture, and shipment of FMT for patients in need.

  5. OpenBiome has convened a panel of medical and public health experts to inform additional safety precautions, and is continually monitoring data associated with the risk of transmission of COVID-19 through stool.

If you have any questions or concerns, please email us at info@openbiome.org. OpenBiome representatives are also available to answer questions by phone (617-575-2201) from 9AM -5PM, Monday through Friday.

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Can COVID-19 be transmitted through stool?

Limited data suggest the virus can be shed and therefore potentially transmitted via stool from both COVID-19 symptomatic and asymptomatic individuals.

OpenBiome material is routinely held in quarantine until it has passed quality assessment and quality control release processes. Moving forward, we are continuing our regular practice of closely monitoring the general health and risk factors of all stool donors while also updating our FMT Quality and Safety Program to match national medical guidelines regarding risks posed by the coronavirus outbreak.

The U.S. Food and Drug Administration (FDA) has recommended that tissue banks screening donors for human cells, tissues, or cellular or tissue-based products should evaluate donors for history of travel to areas of outbreak, cohabitation with infected persons, or suspected/proven COVID-19. Donors that screen positive in any of these three criteria should be placed on hold for at least 28 days. Similar measures have been proposed by an international expert panel of gastroenterologists, the American Association of Blood Banks and by the European Society for Blood and Marrow Transplantation. The steps we have taken at OpenBiome to protect against COVID-19 are consistent with these recommendations. As the outbreak continues and more data become available, we will continue to adjust our measures to reduce transmission and remain consistent with national medical guidelines.

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