The decision is part of the FDA’s efforts to expand testing capabilities for the fast-spreading virus, which has caused over 70,000 deaths in the United States.
The saliva test kit was developed by RUCDR Infinite Biologics, a unit of Rutgers’ Human Genetics Institute of New Jersey, and its collaborators, Spectrum Solutions and Accurate Diagnostic Labs.
The test will cost US$150 and needs to be fully supervised by a practitioner via telemedicine to ensure proper sample collection, a spokeswoman for RUCDR Infinite Biologics’ partner, Vault Health, told Reuters.
“With our team of practitioners, we have capacity to manage 10,000 tests per day and are building to scale,” Vault Health CEO Jason Feldman said.
The agency said the authorization is limited to testing performed at the Rutgers Clinical Genomics Laboratory using their authorized test for COVID-19.
The FDA last month authorized at-home nasal swab sample collection for Laboratory Corporation of America Holdings’ diagnostic kit for COVID-19, the respiratory illness caused by the new coronavirus.
Rutgers received the FDA’s permission last month to collect saliva samples from patients at test sites and Friday’s decision expands the permission to sample collection at the convenience of people’s homes.
Results from the test will be available within 48-72 hours and several thousands of tests will be made available each day, Vault Health said.
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