OraSure’s OMNIgeneORAL kit included in EUA granted to P23 Labs

25 May 2020 (Last Updated May 25th, 2020 09:48)

OraSure Technologies has announced that its OMNIgene.ORAL saliva collection device (OM-505) has been included in the US Food and Drug Administration (FDA) emergency use authorisation (EUA) granted to P23 Labs.

OraSure’s OMNIgeneORAL kit included in EUA granted to P23 Labs
The EUA enables individuals to use OMNIgene.ORAL saliva collection device to self-collect saliva specimen at-home for Covid-19 diagnosis. Credit: NIAID.

OraSure Technologies has announced that its OMNIgene.ORAL saliva collection device (OM-505) has been included in the US Food and Drug Administration (FDA) emergency use authorisation (EUA) granted to P23 Labs.

Developed by OraSure’s DNA Genotek subsidiary, the device is collection kit for the detection of DNA and RNA from viruses. The EUA enables individuals to self-collect saliva specimen at-home for Covid-19 diagnosis.

Combined with P23 Labs’ TaqPath SARS-CoV-2 assay, OMNIgene·ORAL (OM-505) allows identification of nucleic acid from SARS-CoV-2 virus. It uses oral fluid samples self-collected at-home with telemedicine support or in assisted living settings or at a drive through collection site or a doctor’s clinic.

DNA GenotekMolecular Solutions business unit leader and executive vice-president Kathleen Weber said: “OraSure is on the cutting edge of the fight against the Covid-19 pandemic. Our innovative and non-invasive saliva collection kits are designed to make it easier and safer to test for Covid-19, including use in home settings.

“P23 Labs was able to leverage the usability studies for our Oragene·Dx general 510(k) clearance to reduce the time required for submitting their EUA.”

At-home sample collection minimises the risk of virus transmission to others and reduces the demand for personal protective equipment (PPE) for health care providers.

Commenting on the development, P23 Labs Technology and Logistics executive vice-president Eddie McIntyre said: “P23 is focused on providing testing options to populations that are currently underserved by the testing options available today.

“This EUA with DNA Genotek’s collection device will enable testing for people that do not have the ability to get to a collection centre or are at home because they are sick, quarantined, at increased risk for infection or simply concerned about exposing themselves by travelling to a collection site.”

Earlier this month, the OraSure’sORAcollect·RNA kit (OR-100) was included as the collection device for nasal samples with emergency use authorisation granted to Biocernafor its PCR-based SARS-CoV-2 assay.