New SARS-CoV-2 Assay by CosmosID Eases Disruptions in Supply Chain for Patient Fecal Microbiota Transplantation

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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.

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PR NewswirePR Newswire
Retrieved on: 
Tuesday, October 5, 2021
Information
Tags: 
Food, Review, FMT, History of the University of Maryland, College Park, DNA, FDA, Johns Hopkins Bloomberg School of Public Health, Human microbiome, Patient, Physician, OpenBiome, US Foods, Public health, CEO, Genomics, University, Iran National Science Foundation, Agriculture, National Science Foundation, Risk, Johns Hopkins University, COVID-19, Food safety, Algorithm, Severe acute respiratory syndrome coronavirus 2, Safety, Clostridioides difficile infection, Medical device, Pharmaceutical industry
Geotags: 
MARYLAND, CAMBRIDGE, US, GERMANTOWN
Organisation: 
COSMOSID, INC
Summary
Key Points: 
  • 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.
  • "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.
  • The CosmosID platform uses proprietary sequence analysis algorithms to accurately profile all microorganisms in a metagenomic sample employing next-generation DNA sequencing.


New SARS-CoV-2 Assay by CosmosID Eases Disruptions in Supply Chain for Patient Fecal Microbiota Transplantation

GERMANTOWN, Md., Oct. 5, 2021 /PRNewswire/ -- 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 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."

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: https://www.cosmosid.com/cosmosid-hub-covid-19/

About CosmosID
CosmosID®, based in Germantown, Maryland, is a genomics big data company focused on rapid identification of microorganisms for molecular diagnostics, clinical trials, public health, food safety, agriculture, and environmental applications. The CosmosID platform uses proprietary sequence analysis algorithms to accurately profile all microorganisms in a metagenomic sample employing next-generation DNA sequencing. CosmosID was founded in 2008 by Dr. Rita Colwell, former director of the National Science Foundation and currently Distinguished University Professor at the University of Maryland and Johns Hopkins University Bloomberg School of Public Health. To learn more please visit http://www.cosmosid.com.

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SOURCE CosmosID, Inc

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