Donor Screening
At Novel Biome, we understand that the most critical safety component for all FMT products is appropriate and safe donor screening! This is why we make this our #1 priority, ensuring that we manufacture the highest quality product utilizing extensive donor screening, appropriate medical assessment, and blood and stool testing.
Initial Donor Screening
We use stringent screening criteria exceeding all published screening standards 1-10. We only select donors who are vaginally born, breastfed, active, physically fit, have no history of neurological, psychiatric or neurodevelopmental disorders, eat a diverse omnivorous diet, all factors that are known to affect the microbiome 11-13.
A basic screen of their medical history would include the following diseases:
- Chronic infectious disease(s)
- Known exposure to HIV or Viral Hepatitis
- Autoimmune disease(s)
- Gastrointestinal disease or symptoms
- Atopic disease(s)
- Metabolic disorders
- Mood Disorders and Neuro-Atypical
- Neurodegenerative Disorder(s)
- Chronic pain syndrome
- Malignancies
Novel Biome’s initial donor screening goes above and beyond the standard 1-10
| Standard initial medical and health screening 1-10 | Novel Biome’s initial screening |
|---|---|
| -- | Vaginally born |
| -- | Breastfed |
| Donor ages range from ≥18 and ≤60 years old | All donors under 30 years of age |
| General healthy diet | Confirmed diverse omnivorous diet |
| 3 months use of antibiotics, antifungals, antivirals, immune-suppressants, chemotherapy | No lifetime use of antibiotics, antifungals, antivirals, immune-suppressants, chemotherapy |
| -- | Never smoked and lives in a non-smoking home (both tobacco and cannabis) |
| Only recent allergic reactions | No allergies |
| No travel of 6 months to tropical countries and high-risk areas of communicable disease/ infectious intestinal diseases | No travel for 12 months outside of home country |
| Inquire about 13 different infectious diseases | Inquire about 34 different infectious diseases |
| -- | No treatment or diagnosis for ADHD and ADD |
| -- | No sleep issues (e.g. insomnia, frequent waking, nightmares) |
Blood and Stool Testing
Blood and Stool Testing Once a donor has passed our initial screening, we then apply another set of stringent screening to rule out any possible abnormalities that may be found in blood or stool. All our donors reside in North America and undergo both initial and routine (every 90 days) screening that includes over 120 testing parameters to evaluate blood and stool, including parasites, viruses, fungi, and active infections, to ensure all collected and processed materials are safe. To best ensure quality and safety, all processed and manufactured stool is first held in quarantine for 90 days to ensure all blood and stool screening passes our standards. As an added safety measures, we retain a portion of all raw and manufactured samples. This precaution allows us to conduct further testing in the event of an adverse event, ensuring the highest level of safety.
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References: 1.Cammarota et al., 2017, 2. Jørgensen et al., 2017, 3. Australian Regulatory Guidelines of Biologicals., 2020, 4. Cammarota et al., 2019, 5. Mullish et al., 2018, 6. Terveer et al., 2017, 7. Bakken et al., 2011, 8. Kelly et al., 2015, 9. Woodworth et al., 2017, 10. Sokol et al., 2016, 11. Gomaa et al., 2020, 12. Shao et al., 2019, 13. Pannaraj et al., 2017