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.
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“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.