OMNIgene•ORAL (OM-505, OME-505) saliva collection and stabilisation device is developed by DNA Genotek, and detects the SARS-CoV-2 RNA
OMNIgene•ORAL collection device granted FDA EUA. (Credit: Belova59 from Pixabay.)
OraSure Technologies, through its subsidiary DNA Genotek, has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for saliva collection and stabilisation device to test Covid-19.
The new OMNIgene·ORAL (OM-505, OME-505) saliva collection and stabilisation device developed by DNA Genotek, is designed to detect the SARS-CoV-2 ribonucleic acid (RNA).
The company claimed that its testing device is the first to receive FDA EUA for unsupervised use at home or in a healthcare setting, or in combination with an approved or validated at-home test kit.
The FDA authorisation indicates that OMNIgene•ORAL (OM-505, OME-505) can be safely used by patients to collect their own sample, without supervision of a healthcare professional.
DNA Genotek executive vice-president and molecular solutions business unit leader Kathleen Weber said: “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.
“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 authorised.”
OMNIgene ORAL device is intended for self-collection, transport and testing of saliva specimens
The FDA authorisation allows the use of OMNIgene ORAL devices for self-collection, transport and laboratory testing of saliva specimens from people suspected of SARS-CoV-2 infection.
The EUA follows the CE mark approval of OMNIgene ORAL (OME-505), indicated for in-vitro diagnostic use, including for Covid-19 testing, in the European Union (EU).
DNA Genotek is engaged in providing high-quality biological sample collection products and end-to-end services for human genomics and microbiome applications.
The company claimed that its Oragene•Dx and ORAcollect•Dx portfolio are the first and only FDA 510(k) approved saliva-based DNA collection devices for in vitro diagnostic use.
OraSure Technologies is engaged in providing of point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services
OraSure president and chief executive officer Stephen S Tang said: “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.
“The DNA Genotek team quickly leveraged its innovative spirit and expertise with molecular sample collection to address this need with OMNIgene·ORAL and the unsupervised, in-home sample collection that it supports when used as part of a validated at-home test kit.”