A new custom-made SARS-CoV-2 assay has enabled a stool bank to resume patient Fecal Microbiota Transplantation (FMT) treatment distribution and ease supply chain disruptions.

CosmosID, Inc. (Germantown, MD, USA), a microbiome laboratory services company, has provided a testing solution to OpenBiome (Cambridge, MA, USA) which was left with freezers full of processed donor stool samples that could not be released until tested for the SARS-CoV-2 virus. Using the new custom-made testing solution named CosmosID, the stool bank is now able to quickly screen and distribute the stored treatments to patients across the US who suffer from recurrent C. difficile infection.

The custom CosmosID test was implemented by OpenBiome after review by the US Food and Drug Administration (FDA) which has earlier issued a series of safety alerts on the risk of transmitting SARS-CoV-2 via FMT. CosmosID detects SARS-CoV-2 genetic material in donor stool using reverse transcription polymerase chain reaction (RT-PCR) - the same molecular technique used in COVID-19 diagnostic testing. OpenBiome can now test its large inventory of FMT treatments manufactured after December, 2019, which had largely been previously ineligible for distribution per the FDA safety alerts. The test allows OpenBiome to restore its supply chain of FMT treatments and once again make them widely available to patients. In order to successfully develop the test, CosmosID leveraged its scientific team's particular expertise in molecular techniques for analyzing stool samples. The team also flexibly adapted to the changing regulatory requirements during the validation process.

"Our team has extensive experience using next-generation sequencing technologies to analyze gut microbiomes for many different applications – including detecting the presence of disease-causing microbes. We welcomed this collaboration with OpenBiome to come up with a quick and easy test for their banked stool samples, which helps them continue their work," said Manoj Dadlani, CEO of CosmosID.

"CosmosID brought a solutions-oriented mindset to the challenge — they were creative, pragmatic, and proactive, and were utterly committed to the goal of making sure that patients would maintain safe access to fecal transplantation. It has been terrific to collaborate with them on this solution for patients and public health," added Carolyn Edelstein, Executive Director of OpenBiome.

"Rigorous donor screening is critical to enhancing safety and enabling access to FMT for patients with C. difficile who have exhausted all treatment options," said Majdi Osman, Chief Medical Officer at OpenBiome. "Until now, the challenges of directly testing for SARS-CoV-2 in stool have significantly limited physicians' abilities to treat patients with C. difficile infection," he says. "Screening our inventory using the stool-based assay developed by CosmosID will allow thousands of patients to get much-needed treatment for C. difficile infection. For these patients, an FMT is a chance to recover from a debilitating infection and return to a normal life." 

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