Benzinga | Oct 19, 2020 06:02AM EDT

OraSure's OMNIgeneORAL Collection Device Receives FDA Emergency Use Authorization for SARS CoV-2

OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its 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(r)*ORAL (OM-505, OME-505) saliva collection and stabilization device in COVID-19 testing. This is the first FDA EUA that allows for the unsupervised use of the device at-home or in a healthcare setting when used as part of an approved or validated at-home test kit, meaning patients can safely collect their own sample, without the presence of a healthcare professional.

With this FDA authorization, OMNIgene(r)*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). This EUA follows the CE marking of OMNIgene(r)*ORAL (OME-505) for in vitro diagnostic use, including for COVID-19 testing, in the European Union.

"Since the beginning of the pandemic, DNA Genotek has been committed to addressing this global health emergency, and we are pleased to be able to provide a robust solution for easy, safe sample collection that supports detection of this highly contagious virus," said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. "Laboratories and test providers in both the U.S. and European Union can benefit from having a device that collects RNA for SARS-CoV-2, as evidenced by it being both CE marked and FDA authorized."

"Easy-to-use and reliable methods to detect SARS-CoV-2 are crucial to meet the massive need for testing which the Rockefeller Foundation estimates at 2.4 billion tests annually in the U.S. alone," said Stephen S. Tang, Ph.D., OraSure President and Chief Executive Officer. "The DNA Genotek team quickly leveraged its innovative spirit and expertise with molecular sample collection to address this need with OMNIgene(r)*ORAL and the unsupervised, in-home sample collection that it supports when used as part of a validated at-home test kit."

In addition to its device EUA, OraSure announced several other milestones related to the use of DNA Genotek's collection devices for COVID-19 testing:

* Use of DNA Genotek collection kits continue to grow in back-to-work settings, back-to-school programs, and laboratory testing, including: 30,000 students tested at the University of Kansas before returning to campus, via Clinical Reference Laboratory; 64 State University of New York campuses testing students and employees, via Quadrant Biosciences; Test kits available at Albertsons Companies pharmacies throughout the U.S. via Phosphorus Diagnostics; Back-to-work programs integrating COVID-19 testing, monitoring, assessment and access to telemedicine visits for companies, through Azova, Inc.

* DNA Genotek has scaled up manufacturing of saliva collection devices to meet customer demand for COVID-19 testing, and plans to significantly increase capacity in the first quarter of 2021.

* The DNA Genotek kits for detection of the SARS-CoV-2 virus have been included in six customer EUAs. The OMNIgene(r)*ORAL device has been included in EUAs granted to Clinical Reference Laboratory (CRL) and P23. The OraCollect(r)*RNA device has been included in EUAs granted to Biocerna LLC, MiraDx and Quadrant Biosciences. The Oragene(r)*Dx device has been included in an EUA granted to Phosphorus Diagnostics.

* DNA Genotek's devices support both PCR and sequencing-based COVID-19 tests, and its collection kits can be used for collection at home by consumers or by laboratory staff and healthcare providers.