After a rigorous round of validation studies, Phosphorus, a genomics firm headquartered in New York City with a laboratory in Secaucus, said Monday that the U.S. Food and Drug Administration granted an Emergency Use Authorization request for its saliva test for COVID-19, which features at-home sample collection.
OraSure’s Oragene·Dx (OGD-510) saliva collection device proved to be a reliable method for test performance comparable to gold standard methods. The tests were developed at Phosphorus’ CLIA laboratory in Secaucus—only the second at-home, unsupervised saliva test approved so far by the FDA.
Last month Secaucus-based Quest Diagnostics received FDA Emergency Use Authorization for its self-collection kit for COVID-19.
By following a few steps consumers will be able to have test results from the Phosphorus diagnostic within 72 hours of its receipt at the laboratory, and have a consultation with medical personnel.
Phosphorus is also partnering with health care facilities and employers to conduct COVID-19 testing while limiting exposure risks by collecting samples at home.
“COVID testing is essential to getting life back to normal. This test will allow people from coast to coast to be tested from the safety of their homes with the oversight of medical personnel,” said Alexander Bisignano, co-founder and chief executive office of Phosphorus, in a prepared statement. “We thank the FDA for their hard work throughout this crisis and the quick action they have taken. We look forward to helping the country reopen.”
Phosphorus testing protocols use strict standards to ensure accurate and reliable test results. Phosphorus says it is one of the first Emergency Use Authorized assays to have conducted a rigorous clinical agreement study above and beyond the synthetic sample performance study initially required by the FDA.
Using a saliva-based collection method is simple and less intrusive, in comparison to the prevalent swab-based methods. This ease-of-use is a key characteristic to enabling the widespread and repetitive testing protocols proposed by experts to contain the COVID-19 pandemic.