We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
LGC Clinical Diagnostics

Download Mobile App





New Stool-Based Assay Detects SARS-CoV-2 Genetic Material in Donor Stool Using RT-PCR

By LabMedica International staff writers
Posted on 06 Oct 2021
Print article
Illustration
Illustration

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."

Related Links:
CosmosID, Inc. 
OpenBiome 

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
One Step HbA1c Measuring System
GREENCARE A1c
POCT Fluorescent Immunoassay Analyzer
FIA Go
Gold Member
SARS-CoV-2 Test
One Step SARS-CoV-2 Nucleic Acid Detection Kit (P761H)

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: MOF materials efficiently enrich cfDNA and cfRNA in blood through simple operational process (Photo courtesy of Science China Press)

Blood Circulating Nucleic Acid Enrichment Technique Enables Non-Invasive Liver Cancer Diagnosis

The ability to diagnose diseases early can significantly enhance the effectiveness of clinical treatments and improve survival rates. One promising approach for non-invasive early diagnosis is the use... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more

Pathology

view channel
Image: The OvaCis Rapid Test discriminates benign from malignant epithelial ovarian cysts (Photo courtesy of INEX)

Intra-Operative POC Device Distinguishes Between Benign and Malignant Ovarian Cysts within 15 Minutes

Ovarian cysts represent a significant health issue for women globally, with up to 10% experiencing this condition at some point in their lives. These cysts form when fluid collects within a thin membrane... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.