Until last week, at-home testing had been prohibited by regulators. But in a notable breakthrough, the U.S. Food and Drug Administration has now cleared the way for a Rutgers University lab and its partners to begin distributing at-home saliva tests to patients by way of mail, not unlike commonly used genealogy DNA tests.
Dr. Andrew Brooks, the Rutgers scientist who developed a saliva test, told ABC News the early use of the test at designated field collections sights in New Jersey has already yielded two dramatic benefits. The collection is fast, so screeners at drive-through sites were able to test four times more patients per hour than the more common nasal swabs. And because the test is non-invasive, Brooks said healthcare workers used far less protective gear as they conducted the brief saliva collection.
The question now is whether the fledgling industry surrounding at-home collection can mobilize to meet the demands of a nationwide crisis.
Feldman and Mehdi Maghsoodnia, the CEO of Vitagene, another test kit distributer, both said in interviews that they would not be able to exceed 30,000 tests per day until more labs are authorized by the FDA to join in processing saliva samples.
Leslie Bryant, a spokesperson for Spectrum Solutions, the test kit developer, agreed that the bottleneck at the lab processing stage would not resolve until more labs are authorized by the FDA. Officials at the FDA said they could not comment on whether more lab applications are pending.
In anticipation of last week’s FDA ruling, Bryant said Spectrum has been in frequent communication with manufacturing partners and has made efforts to forge new relationships in order to meet production demands for the at-home test kits. Those manufacturing partners are “working feverishly, going 24 hours-a-day, hiring new staff,” Bryant said.
© Spectrum Solutions™ COVID-19 SDNA-1000 Saliva Collection Testing Kit | Bloomberg News/George Frey