NEW YORK – P23 Labs has received Emergency Use Authorization for its coronavirus PCR test from the US Food and Drug Administration.
The TaqPath SARS-CoV-2 test is authorized for use with oropharyngeal, nasopharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal wash, nasal aspirate specimens, and bronchoalveolar lavage samples. In addition, it can use saliva samples collected using OraSure Technologies' Omnigene Oral OM-505 saliva collection device.
The kit, from OraSure subsidiary DNA Genotek, allows patients to self-collect oral fluid samples at home with support from a clinician via telemedicine, in an assisted living setting, at a doctor's office, or at a drive through collection site. Self-collection reduces the chance of virus spread to healthcare workers and lowers demand for personal protective equipment, OraSure said.
P23 Labs relied on usability studies from DNA Genotek's 510(k) clearance for Omnigene to reduce the time required to submit its EUA application, OraSure said.
"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," Eddie McIntyre, executive VP for technology and logistics at P23 Labs, said in a statement.
In April, OraSure's Oracollect RNA kit was included as the collection device for nasal samples for Biocerna's EUA. The same month, OraSure was awarded a $710,310 contract from the Department of Health and Human Services' Biomedical Advanced Research and Development Authority to develop a pan-SARS-coronavirus antigen self-test using oral fluid samples.