The P23 Labs’ TaqPath SARS-CoV-2 assay, combined with OMNIgene•ORAL (OM-505), facilitates the detection of nucleic acid from SARS-CoV-2 using oral fluid samples self-collected at-home with telemedicine support or in an assisted living setting, at a doctor’s office or at a drive through collection site
OraSure Technologies, a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, (NASDAQ: OSUR), announced today that its OMNIgene®•ORAL saliva collection device (OM-505) was included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to P23 Labs.
This EUA permits individuals to self-collect saliva specimens at-home for the detection of SARS-CoV-2.
The P23 Labs’ TaqPath SARS-CoV-2 assay, combined with OMNIgene®•ORAL (OM-505), facilitates the detection of nucleic acid from SARS-CoV-2 using oral fluid samples self-collected at-home with telemedicine support or in an assisted living setting, at a doctor’s office or at a drive through collection site. A product of OraSure’s DNA Genotek subsidiary, OMNIgene®•ORAL (OM-505) is an all-in-one collection kit for the detection of DNA and RNA from viruses.
This is the second EUA that utilizes a DNA Genotek collection device. Earlier this month, the Company’s ORAcollect®•RNA kit (OR-100) was included as the collection device for anterior nares (nasal) samples EUA granted to Biocerna LLC for its PCR-based SARS-CoV-2 assay.
“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,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. “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. We are proud of our on-going commitment to regulatory compliance which provides our customers with a high degree of confidence in our medical device products.”
At-home self-collection with telemedicine support enables individuals to self-administer sample collection. This reduces the risk of virus transmission to others and lowers the demand for personal protective equipment (PPE) for health care providers, as the test does not require an in-person visit with a clinician.
“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 center or are at home because they are sick, quarantined, at increased risk for infection or simply concerned about exposing themselves by traveling to a collection site,” said Eddie McIntyre, Executive Vice President, Technology and Logistics, at P23 Labs. “The device’s intuitive ease-of-use facilitates minimally supervised or in most cases complete self-collection and is a tremendous advance to current COVID-19 sample collection methods.”
Source: Company Press Release