Phosphorus Covid-19 test is said to be only the second at-home unsupervised saliva test secured approval from the FDA
Phosphorus has secured FDA EUA status for Covid-19 at-home saliva test. (Credit: fernando zhiminaicela from Pixabay)
Genomics company Phosphorus has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its at-home saliva test for Covid-19 disease.
The Covid-19 saliva test, which features at-home sample collection, is available via health care and employer partnerships. It is also available to consumers online.
Phosphorus test is claimed to be only the second at-home unsupervised saliva test secured approval from the FDA.
According to the company, the saliva-based collection method is simple to use compared to the prevalent swab-based methods.
The test will be provided to the consumer based on the review and approval from an independent physician.
Phosphorus at-home saliva test enables to generate test results within 72 hours
The test results can be generated within 72 hours after receipt at the laboratory and will be accompanied by a consultation from medical personnel.
Phosphorus is also collaborating with health care facilities and employers to carry out Covid-19 testing while minimising exposure risks by collecting samples at home.
Phosphorus also stated that it is in full compliance with FDA Guidelines for Diagnostic Tests for Coronavirus Disease-2019 during a Public Health Emergency and submitted validation data under the FDA’s EUA authority.
OraSure’s Oragene Dx (OGD-510) saliva collection device is said to be a suitable method for test performance comparable to gold standard methods.
Phosphorus co-founder and CEO Alexander Bisignano said: “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.
“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 re-open.”
Phosphorus offers advanced genomic tests using next-generation sequencing (NGS) technologies to healthcare providers and hospitals.
Recently, Siemens Healthineers secured EUA status from the FDA for its SARS-CoV-2 total antibody test.