Minnesota is seeking to more than double its coronavirus testing capacity by adding a new diagnostic tool to its arsenal: saliva tests that, in some cases, can be done at home.
The saliva tests stand to make Minnesota’s COVID-19 response more nimble, and more widespread. State officials hope the addition will allow Minnesota to expand its testing to communities that haven’t been able to access tests in the past — and, with more information about how COVID-19 is spreading through the state, suppress potential outbreaks before they begin.
“We need more capacity, and more diverse capacity,” said Minnesota Department of Health Commissioner Jan Malcolm.
The state is planning to dedicate more than $14 million from its cache of federal CARES Act coronavirus relief funding to contract with Vault Health, a men’s health startup that partnered with RUCDR Infinite Biologics, a part of the Rutgers University Human Genetics Institute of New Jersey, to develop the test.
About $5 million of that funding will be used to open a test processing site in Oakdale, Minn., plus 10 temporary sample collection sites around the state. An additional $9 million will be used to cover the cost of the tests, though Malcolm said she expects Minnesota health insurance plans to cover those costs, as they have for other COVID-19 diagnostic tests.
The state hopes this new arm of its testing strategy will be open as early as September — and projects that, once fully operational,will be able to process as many as 30,000 saliva tests a day.
A new dimension to state’s testing plan
Right now, most people are diagnosed with COVID-19 through a swab test: A sample is swabbed from the back of their throat or deep inside or nasal cavity. Depending on where the sample is taken, a test might be sent away to a national lab for analysis, or to a lab in-state.
Minnesota has the capacity to process 22,000 of these tests daily, mostly through Mayo Clinic and the University of Minnesota.
But conducting those tests takes up a lot of resources: Getting good nasal samples requires highly trained medical staff. Those specialists must wear personal protective equipment, which can be scarce. And collecting and processing those samples relies on materials that are in short supply — and high demand — nationally.
Saliva tests stand to cut down on the labor, materials and time it takes to process lab results in part because the Vault test can also be done at home. Patients can order a test kit online, collect and package their own saliva sample at home with virtual coaching from a Vault employee, and send the sample off for processing. Results are typically available by email within 48 hours.
But people can also go to one of the collection sites to give saliva samples in-person. And Malcolm says Health Department employees will take the saliva tests on the road through mobile testing units in an effort to target under-served communities.
School reopenings are also a big driver behind this plan, Malcolm said. As kids get all sorts of viruses that could be mistaken for COVID-19, the state will need additional capacity to meet that demand. Universities may want to tap into this new capacity as well.
“This added capacity will allow us to test more of our priorities, be able to respond to spikes in cases, and more importantly, help prevent growth in cases by doing more targeted testing,” Malcolm said.
The Vault/RUCDR test is already being used by some New Jersey counties, but also by corporations like Bristol Myers Squibb, Major League Baseball and Space X.
Vault’s contract with Minnesota would represent the first the company has secured to be part of a statewide testing strategy, according to a company spokesperson.
Now, those samples must be sent to Rutgers for processing. But Minnesota’s plan would process the tests locally. With some people waiting days for test results, Malcolm said it could help shorten response times.
Already, the state has made the Vault/RUCDR test a part of the state’s school reopening strategy, giving teachers one saliva test at no cost.
FDA’s emergency green light
Vault/RUCDR was given emergency use authorization from the Food and Drug Administration this spring. Earlier this month, the FDA also gave emergency use authorization to a separate saliva test developed by Yale University.
Emergency use authorizations allow products that haven’t been approved by the FDA to be used by doctors or sold on the market during emergencies — like a pandemic. It’s a process some scientists say has been used too liberally under the Trump administration, as the federal government scrambles to fight the virus.
For instance, early in the pandemic, FDA granted early use authorizations to some antibody tests — which are meant to determine whether a person’s immune system has been exposed to the coronavirus — that ended up not working well. And more recently, the FDA revoked its emergency use authorization for hydroxychloroquine to be used to treat COVID-19.
Nevertheless, Malcolm said the state is confident the saliva test produces accurate results. She says research reviewed by the state Health Department shows it’s as sensitive and accurate as other diagnostic tests on the market.
But Dr. Alan Wells, a pathologist and medical director for the University of Pittsburgh Medical Center Clinical Laboratories, says the saliva test is only appropriate for some populations.
“Different testing is appropriate for different situations, depending on the acuity of the patient and the vulnerability of the patient to COVID,” said Wells.
Wells says the research suggests that nasal swabs that go deep into a patient’s nasal cavity offer the most accurate test results. But he said that saliva tests have been valuable in detecting COVID-19 in people who are, for instance, asymptomatic — as long as the sample is collected correctly. It’s an important component to the state’s strategy to first test, then isolate patients who have the virus, even if they aren’t showing symptoms.
“The advantage to getting to larger numbers of people for surveillance, for groups that are not highly vulnerable — not your transplant patients or your skilled nursing facility patients — is that these are much more attainable and rapidly collect-able,” Wells said.
COVID-19 in Minnesota
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