NEW YORK (GenomeWeb) – DNA Genotek today announced its Omnigene Gut microbiome collection kit has received CE-IVD marking.
The kit can now be marketed in Europe. It is available for research use only in the US. Omnigene Gut is an all-in-one system for the self-collection of high-quality microbial DNA from stool for gut microbiome profiling for use in clinical laboratory and research-use settings. DNA Genotek, a subsidiary of OraSure Technologies, said that the kit ensures that the fecal sample is fully stabilized immediately upon collection and maintains an accurate and reliable profile for weeks at room temperature.
DNA Genotek President Ian Curry said in a statement that CE-IVD marking of the product "is a major step forward in assuring labs and clinicians that they can rely on Omnigene Gut to stabilize the sample at point of collection, resulting in optimal assessment and classification of the gut microbiome."