OraSure Technologies, Inc.’s DNA Genotek subsidiary has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the use of DNA Genotek’s OMNIgene ORAL (OM-505, OME-505) saliva collection and stabilization device in coronavirus disease 2019 (COVID-19) testing. This is the first FDA EUA that allows for the unsupervised use of the device at-home or in a health care setting when used as part of an approved or validated at-home test kit, meaning individuals can safely collect their own sample, without the presence of a health care professional.
With this FDA authorization, OMNIgene ORAL devices can be used for the self-collection, transport, and laboratory testing of saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA). The test has already been granted a CE Mark for use in the European Union. DNA Genotek has increased manufacturing of saliva collection devices to meet consumer demand for COVID-19 testing, and plans to significantly increase capacity in the first quarter of 2021.
OraSure Technologies, Inc. develops, manufactures, and distributes rapid point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services that are designed to detect medical conditions. OraSure is the parent company of DNA Genotek Inc., which focuses on providing high-quality biological sample collection products and end-to-end services for human genomics and microbiome applications.
This was reported by OraSure Technologies, Inc. on October 19, 2020.