BY: SASHA PEZENIK and MATTHEW MOSK
(NEW YORK) — With demand for coronavirus testing expected to rise even higher this fall as students return to campuses across the nation, some major universities are adding their names to the list of those turning to at-home test kits that look for the virus in a person’s saliva — a novel technique that’s raised hopes, and questions, when it comes to mass testing.
Though they are not as widely used as nasal swabs and some scientists caution that the federal government granted emergency authorization for the method based on a relatively small sample, test makers are touting the spit test as a convenient, accurate and speedy alternative at a time when major labs are facing backlogs. Some school officials said they’re willing to give it a try.
“The current benefits outweigh the risks,” Purdue University Chief Medical officer Dr. Esteban Ramirez told ABC News. “The beauty of this is that we can screen and test everyone before they arrive on campus.”
Purdue officials said they plan to test every one of their 40,000 students with saliva kits prior to the fall semester. They are counting on the novel screening approach to flag any infections before symptoms show — and the virus spreads. Further testing will be made available, if necessary.
Officials at Vault Health, a New York company that has been advertising the saliva test to universities and is working with Purdue, told ABC News that in two months they have seen a significant increase in orders for the at-home kits, which closely resemble those used by commercial genealogy companies like Ancestry.com and 23 & Me. A Rutgers lab, which developed the saliva test used by Vault Health and others, says it is now processing 50,000 samples daily, with plans to handle more than 100,000 daily tests this fall.
The University of Oklahoma announced Monday that it was partnering with Vault to mail students an at-home test “to complete in advance of their arrival on campus.” A spokesperson for Pepperdine said that university is working to acquire at-home tests from the company as well.
University officials say they don’t have a perfect strategy for reopening, but are doing the best they can with the tools available.
“There is no playbook for reopening [a] college campus,” Dr. Dale Bratzler, University of Oklahoma’s Chief COVID Officer, said on a videoconference call outlining the school’s strategy Monday. “The entire team has been working really hard to make the campus as safe as possible. Testing is just one piece of the strategy.”
An Oklahoma University spokesperson told ABC News they’re still trying to determine whether they will mandate further periodic testing, and if they’ll lean more heavily on swab kits or saliva. It depends on how this round goes.
Currently the leading type of test in widespread use in the U.S. remains the nasal swab tests, which are conducted at clinics, drive-in testing sites and hospitals across the country, then shipped off to labs for processing. Those sites have witnessed a surge in demand, leaving the nation’s labs confronting backlogs that are delaying results. Some are reporting waiting more than a week for their results, which experts say can defeat the point of taking the test.
More testing options could help mitigate that bottleneck, proponents of the saliva tests say. The saliva kit, for instance, requires no swabs — a key component of the nasal tests that has run into supply issues.
The method also enables users to test from home and, with kits shipped to labs for analysis, the companies tout a turnaround time of 48 hours. The convenience comes at a price: kits can cost $150 compared to free tests offered at drop-in and drive-through locations.
Dr. David Reich, President of Mount Sinai Hospital in New York, said the nasal swab, or the “nasopharyngeal swab,” remains the “gold standard” in coronavirus testing, but he’s among experts who told ABC News he’s hopeful saliva tests prove effective.
Companies that distribute the saliva tests have advertised their work for high-profile clients, like pro athletes in the NBA and golfers on the PGA Tour. But with schools eyeing fall openings, the customer base is expanding.
“One big area of focus is on education — trying to help schools bring back large populations of people,” said Jason Feldman, the CEO of Vault Health. “That’s a huge area of growth.”
Emergency authorization comes with expert caution
The Food and Drug Administration provided an emergency authorization for a test processed by Rutgers Clinical Genomics Laboratory in May — opening the market to at-home saliva tests processed by the Rutgers lab, including those sold by Vault Health and other companies. The authorization was based on success the lab reported in comparing results between saliva and nasal swabs, using only 60 samples. Though the sample was small, the results cited a 100% agreement, according to the data the lab reported to the FDA.
In approving Rutgers’ application, FDA Commissioner Dr. Stephen Hahn called the at-home sample collection an “easy, safe and convenient” way to broaden patients’ access to COVID-19 testing, adding that his team would “work around the clock” to further support the development of accurate, reliable tests.
The FDA has also started to ask the Rutgers lab to process “reference samples” that will enable regulators to monitor the performance of the tests – one requirement of the emergency authorization.
Since Rutger’s initial application, emergency authorizations have been granted to other labs developing tests using “oral fluid” supervised self-collection, including Curative Inc. in partnership with Korva Labs, and P23 Labs.
An FDA spokesperson said the emergency authorization is not the end of the process, and regulators continue to speak with each company marketing tests to monitor weakness or find improvements. The ultimate goal is to ensure a good test reaches the public when it is needed most, the spokesperson said.
Experts told ABC News that the urgent need caused by the coronavirus outbreak meant the FDA moved forward with that small sample size, and that more study is needed to provide assurance that this novel approach of collecting patient samples — through saliva — can work on a mass scale.
“Everyone was scrambling and they approved a lot of these tests, especially from university labs, very readily,” said James R. Baker, an immunology expert at the University of Michigan’s Michigan Medicine. “Then it became a commercial product without the kind of data you normally would need.”
Angela Rasmussen, Associate Research Scientist at Columbia University Mailman School of Public Health, told ABC News she thought saliva tests could become “the wave of the future,” but only if it’s properly validated.
“A lot of the tests don’t require a ton of validation,” Rasmussen said. “But if you want to make a test that will stand the test of time, you’re going to need to do that validation, because if you roll out prematurely it can cause all sorts of problems.”
In late May the FDA also cautioned that at-home sample collection in general raised some “unique concerns about safety and accuracy.”
Companies like Vault Health have tried to alleviate some of those concerns by offering supervised self-testing, attempting to ensure the do-it-yourself sample collection is done with efficiency and accuracy. Via tele-health video call, a health care professional, typically a nurse, will guide the patient through the procedure.
The director of the Rutgers lab, Andrew Brooks, told ABC News the initial data samples were small because “we were preventing the over-run of the healthcare system,” and that the kind of study required of commercial labs during healthy times would be “extremely difficult” during the crush of an outbreak.
However, Brooks said Rutgers continues to do internal quality control screening to monitor test performance, and the university has commissioned a study of about 1,000 individuals who are being tested routinely with both nasal swabs and saliva collection. That study, which Brooks said would eventually be published and was not shared with ABC News, is showing the two delivering identical results in 96% of the samples, he said.
“We’re scaling and running more tests,” Brooks said. “Are we seeing a difference in performance? The answer is no.”
‘We have to go off the best we can’
From the early days of the outbreak, the scientists involved in creating the saliva test saw the potential as an easier method of testing — one that could be done in isolation, protecting both patients and those who conduct the tests from added exposure.
“It opens up a lot of doors,” Brooks told ABC News in April. “For people that don’t have cars, that don’t have access, that are on quarantine, it makes [testing] more broadly available.”
Brooks had previous experience and a financial interest in DNA collection kits, which use methods similar to the coronavirus saliva test. He serves as chief scientist for Spectrum DNA, the company already supplying those kits for genealogy tests, and he developed the special preservative those tests use. Rutgers announced last month Brooks would head a spin-off venture, called BiologiX, to expand the commercial sales of saliva tests.
Brooks said he expects the FDA to seek “a full package” of data from the commercial enterprise, once the nation is beyond the health emergency.
Until then, he said he is scaling up saliva testing while adhering to the tight restrictions of the emergency authorization – including a requirement that the tests be distributed based on a physician’s order. For universities, for instance, he said that means sending test kits only in response to a request from the school’s medical officer, justifying the need based on plans to have students living in close quarters.
For some universities contending with safely bringing back thousands of students, the idea of more convenient testing has proved attractive, even if the science isn’t settled.
Purdue’s Ramirez acknowledged that no testing platform can provide guaranteed results, given how quickly the tests were developed to address a virus that was on no one’s radar six months ago.
“With COVID there just isn’t yet a ton of robust, strong, long-term evidence, what we have is literally on the order of months.” Ramirez said. “But we have to go off the best we can.”
U.C. Berkeley announced in late June they had launched a trial run for saliva testing, and if the study proved that method reliable, the university could ramp up monitoring ahead of the August class start.
“We hope that if it works well here, we can help disseminate this strategy elsewhere,” Dr. Jennifer Doudna, professor of biochemistry at U.C. Berkeley and executive director of the Innovative Genomics Institute said in a statement announcing Berkeley’s saliva experiment.
The universities are following the lead of some sports leagues that have included saliva tests in their efforts to track potential spread of the virus.
PGA officials said golfers submit saliva tests before they travel to a tournament, and then may take a nasal swab test during tournament play.
“We’re learning things about this virus, medically, every day,” Senior Vice President of PGA Tournament Administration Andy Levinson told ABC News.
The NBA, which said it is a client of Vault, focuses on testing for player and staff families. The league is is also working with researchers at the Yale School of Public Health to study the results of yet another saliva test – one that is awaiting FDA authorization, scientists behind the Yale research say. Players, coaches and staff opt into the study, and opportunity for comparison in analyzing new testing methods’ accuracy and sensitivity.
“My hope is that this can expand testing options, show people what can be done,” Anne Wyllie, associate research scientist at the Yale school of Public Health and the study’s first author, told ABC News. “I hope that it helps to add to the growing data that is out there, maybe spark others to get creative with what they’re doing.”
The test their team is developing aims at offering an option that is designed to be less expensive than those currently on the market. That helps, Wyllie noted, given the urgent need for repeat testing.
In a nation now looking to heal and reopen, those responsible for doing it safely recognize that the stakes are high, and the margin for error is slim — a missed infection can fan the spread of the virus and prolong the ongoing health crisis.
Ramirez said at Purdue, the university will monitor results and try to remain nimble.
“We kind of have to flex with the scientific literature,” he said. “But we’re excited to get this off the ground.”
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