31 January 2023

Adelaide’s BiomeBank recently made the news when they became first in the world to gain regulatory approval for a donor derived microbiome product, BIOMICTRA. The product is used to restore the gut microbiome after recurrent Clostridioides difficile infection. C. difficile infection, a bacterial infection in the gut, causes severe diarrhoea and inflammation. In the elderly the infection can be fatal, and in most it is highly debilitating. BiomeBank’s product introduces microscopic organisms from a healthy gut into the patient’s diseased gut, restoring gut function in 81%-96% of cases.

The product is developed from donor faeces. Faeces, also called stool, excrement, poo – take your pick, the list is endless – are a rich source of the microscopic organisms that live in the gastrointestinal tract (the faecal microbiome) and play a crucial role in our health and wellbeing. Donor faeces from healthy individuals are used to generate a product that can be transplanted to restore a healthy microbiome in patients suffering from a C. difficile infection.

Finding a suitable donor is not easy. Donors need to be thoroughly screened to ensure they are healthy and can deliver a diverse microbiome with a low risk of pathogens transfer. To gain Therapeutic Goods Administration (TGA) approval, the company needed to prove that they use only high-quality poo in their product.

SA Pathology has been BiomeBank’s screening partner throughout product development and continue to test potential donors before they are ‘on-boarded’. The general health of donors is screened through an extensive medical questionnaire followed by haematology and biochemistry blood tests, and donor serology screening is performed to exclude infection with blood-borne viruses such as hepatitis B. Donors are regularly screened for SARS-Cov-2, and, perhaps most importantly, donor faecal samples are extensively tested for the presence of intestinal microbial pathogens using bacterial culture and nucleic acid testing for bacteria, parasites, and viruses.

‘We would love to acknowledge SA Pathology's role in BiomeBank's recent TGA approval. Donor screening testing is critical to the safety of this product and we are very grateful for SA Pathology’s expertise and support,’ Dr Costello said.

It is also worth noting that this work occurred as SA Pathology, and particularly MID, were responsible for delivering South Australia’s response to the pandemic.

While SA Pathology staff regularly contribute in many ways to research projects in South Australia, rarely is the loop closed and the impact of this work communicated once the project is finished. We thank Sam and Emily for recognising the important but often unacknowledged work our laboratory staff do for research and development in South Australia.

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