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The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Phosphorus for its at-home saliva test for Covid-19.
Developed at Phosphorus’ CLIA laboratory in New Jersey, US, the Covid-19 test uses OraSure’s Oragene ·Dx (OGD-510) saliva collection device for the detection of SARS-CoV-2 virus.
Customers can order the test through the online checkout process at the company’s website. They will be required to complete a medical questionnaire, which will be reviewed by an independent physician for approval. Once approved, the company will ship a sample collection kit to the customer’s address.
The customers will receive test results within 72 hours, accompanied by a consultation from medical personnel.
Phosphorus has partnered with IRMS Institute for Reproductive Medicine and Science at Saint Barnabas to conduct the Covid-19 testing.
The FDA emergency use approval follows a rigorous round of validation studies, in addition to the synthetic sample performance study initially required by the agency, the company noted.
Furthermore, the test is the second at-home unsupervised saliva test to be approved by the FDA.
Phosphorus co-founder and CEOAlexander Bisignano said: “Covid-19 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.”
In 2017, Phosphorus introduced new genetic tests for the detection of hereditary cancers.
The company offers advanced genomic tests based on next-generation sequencing (NGS) technologies to healthcare providers and hospitals.