New Stool-Based Test Detects SARS-CoV-2 Genetic Material in Donor’s Stool Using RT-PCR – COVID-19
A new bespoke SARS-CoV-2 test has enabled a stool bank to resume delivery of fecal microbiota transplant (FMT) treatment to patients and ease supply chain disruptions.
CosmosID, Inc. (Germantown, MD, USA), a microbiome laboratory services company, provided a test solution to OpenBiome (Cambridge, MA, USA) which ended up with freezers full of ‘stool samples from treated donors that could not be released before being tested. for the SARS-CoV-2 virus. Using the new bespoke testing solution named CosmosID, the stool bank is now able to quickly filter and dispense stored treatments to patients in the United States who are suffering from recurring problems. It’s hard infection.
The personalized CosmosID test was implemented by OpenBiome after review by the United States Food and Drug Administration (FDA), which previously issued a series of safety alerts about the risk of transmission of SARS-CoV-2 via FMT. CosmosID detects the genetic material of SARS-CoV-2 in the donor’s stool using reverse transcription polymerase chain reaction (RT-PCR) – the same molecular technique used in COVID-19 diagnostic tests. OpenBiome can now test its large inventory of FMT treatments manufactured after December 2019, which were previously largely ineligible for distribution according to FDA safety alerts. The test enables OpenBiome to restore its supply chain of FMT treatments and once again make them widely accessible to patients. In order to successfully develop the test, CosmosID relied on the particular expertise of its scientific team in molecular techniques for analyzing stool samples. The team also flexibly adapted to changing regulatory requirements during the validation process.
“Our team has extensive experience in using next-generation sequencing technologies to analyze gut microbiomes for many different applications, including detecting the presence of pathogenic microbes. We welcomed this collaboration with OpenBiome to offer a quick and easy test for their banked stools. samples, which helps them continue their work, ”said Manoj Dadlani, CEO of CosmosID.
“CosmosID brought a solution-oriented mindset to the challenge – they were creative, pragmatic and proactive, and were fully committed to the goal of ensuring that patients would maintain safe access to fecal transplantation. It has been great working with them on this solution for patients and public health, ”added Carolyn Edelstein, Executive Director of OpenBiome.
“Rigorous donor screening is essential to improve safety and enable access to FMT for patients with It’s hard who have exhausted all treatment options, ”said Majdi Osman, Medical Director of OpenBiome. “Until now, the challenges of testing directly for SARS-CoV-2 in stool have significantly limited the ability of physicians to treat patients with It’s hard infection, ”he says. “Screening our inventory using the stool-based test developed by CosmosID will allow thousands of patients to obtain much needed treatment for It’s hard infection. For these patients, FMT is a chance to recover from a debilitating infection and return to normal life. “