7th October 2021 Product update: rapidvirology staff writer
Genomics Team Develop SARS-CoV-2 Stool Screening Assay to Help FMT Resume
In early 2020 when the US Food and Drug Administration (FDA) issued a series of safety alerts on the risk of transmitting SARS-CoV-2 via fecal microbiota transplantation (FMT), the Cambridge-based stool bank OpenBiome was left with freezers full of processed donor stool samples that could not be released until tested for the new virus.
Now, thanks to a testing solution provided by the microbiome laboratory services company CosmosID, the stool bank is 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, which OpenBiome implemented after review by the FDA, 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 will 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.
Carolyn Edelstein, Executive Director of OpenBiome, says, "CosmosID brought a solutions-oriented mindset to the challenge — they were creative, pragmatic, and proactive, and we're 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."
Manoj Dadlani, CEO of CosmosID, says in order to successfully develop the test, the company 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.
Dadlani says, "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."
Majdi Osman, Chief Medical Officer at OpenBiome, emphasizes the test's importance to patients. "Rigorous donor screening is critical to enhancing safety and enabling access to FMT for patients with C. difficile who have exhausted all treatment options. 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."
To find out more, visit the CosmosID website or send a quick info request using the button provided below.
Date Published: 7th October 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.