nevodka/iStockBy MATTHEW MOSK and LUCIEN BRUGGEMAN, ABC News
(NEW YORK) — A handful of U.S. health care companies are banking on massive demand for coronavirus tests and an easing of federal rules as they prepare for a major production blitz that could bring at-home saliva test kits to millions of Americans in the coming months.
“The plan is to keep scaling,” said Jason Feldman, the CEO at Vault Health, one of the companies that recently started selling at-home saliva test kits, which rely on a sample of spit in a test tube, which is mailed into a New Jersey lab to screen for COVID-19.
Feldman said his company currently has the capacity to ship 30,000 tests-a-day to consumers at home, who are asked to submit their sample under the watch of a healthcare professional on a teleconference, before they are shipped to the Rutgers lab for processing. He is hoping that number will steadily rise.
“The demand is endless,” he said.
While experts agree that any plan to reopen the country relies on the ability to repeatedly test large swaths of the population, a streamlined approach to achieving that lofty goal remains elusive. But experts are increasingly touting the potential of at-home saliva tests, deemed by researchers to be a more convenient and reliable alternative to nasal swabs.
“For companies trying to make decisions about who can come into work and who should stay home, a diagnostic test that allows people to test at some level of frequency will be super helpful — and an at-home saliva test could help allow for that,” said Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor.
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 approved 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.
The spit-tubes and labels are sent to consumers in a small, re-sealable box, a packet that was subjected to its own approval process to be sure samples could be safely shipped to the lab without breaking or being contaminated. But the ingredient that represented a breakthrough for Spectrum was the preservative inside the tube that enables the sample to be processed.
COVID-19 tests are intended to be free. But companies marketing the at-home tests are charging around $150.
Spectrum currently has the capacity to distribute more than a million of the test kits per month, according to Bryant, with hopes to reach 15 million test kits per month by the end of 2020.
The manufacturers and distributors are also waiting for the Centers for Disease Control and Prevention to formally recommend testing for people without symptoms. Under current federal recommendations, physicians are supposed to prioritize tests for patients showing signs of a coronavirus infection.
Maghsoodnia said once those constraints come off, he believes his company — which has experience processing saliva DNA tests for the nutrition company GMC — said the potential for widespread testing is limitless.
“We believe we can get to 1 million units a month,” Maghsoodnia said. “We are balancing between the need of widespread testing and the strict language of the FDA and CDC guidelines that are restricting widespread testing. We need to get FDA and CDC to put it in the letter of the law.”
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