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Labs Launching SARS-CoV-2 Testing Programs Aimed at Colleges and Universities

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NEW YORK – Much of the discussion around reopening the US economy has revolved around workplace SARS-CoV-2 testing, but with the start of the academic year just a few months off, schools — and colleges and universities, in particular — are stepping into the spotlight.

Many of the labs that are currently active in workplace testing are now putting together plans for school SARS-CoV-2 testing, with a number of them saying that they are seeing strong interest from institutions in doing at least an initial round of testing covering all students and faculty. Given the roughly 20 million college students in the US, this could lead to a significant spike in test demand in late August and early September.

San Francisco-based genomic testing firm Color has built up a SARS-CoV-2 workplace testing program in recent months. Now the company is beginning to set up a school testing program and is currently in discussion with or has contracted to do testing for more than a dozen higher education institutions across the country, said Caroline Savello, Color's chief commercial officer.

She said these institutions ranged in size from small liberal arts schools with enrollments in the low thousands of students to state schools with more than 50,000 students.

Schools are beginning to focus on the issue as they plan for the coming fall session and try to communicate those plans to students and parents and faculty, she said.

For many institutions, this will involve bringing together in close proximity thousands of students from different geographies all across the US, each of which is dealing with its own local conditions in terms of virus spread and positive rates.

Given this situation, Savello said there is a general consensus among the institutions Color has spoken with that they would like to do an initial round of testing on all students and faculty at the start of the year — testing them either at home before they come to campus or, more likely, she said, shortly after they arrive at campus.

"The logistics of that, as you can imagine, for a 65,000-person university are quite complex," she said. "Testing that many people through the student health clinic isn't an option. You're never going to get that throughput by having people schedule an appointment with a physician."

This points toward a need for self-sampling tests, and Savello said Color is "very aggressively working on less logistically complex sample collection methods including unmonitored collection."

"What you want to have happen in a university setting is multiple points around campus where it is extremely rapid and simple for any individual to submit a sample for a test at any time, whether they are symptomatic in a specific context, whether they are asymptomatic," she said. "You envision people walking up to a table, picking up a sample collection kit, administering it and dropping it off. That's what we are designing for, that kind of model."

The college and university setting is also a new one for Opko Health's BioReference Laboratories, noted Kevin Feeley, the company's CFO, but it too is moving to set up SARS-CoV-2 testing for this setting.

"For the better part of a month we've been in fairly regular contact with multiple universities and colleges across the country," he said. "We're expecting decision points in short order in order to properly plan for what will be a fairly large volume of operations that need to be put in place in that late August timeframe."

Feeley said that most schools he has spoken to are looking to give all returning students, faculty, and staff a SARS-CoV-2 molecular test along with a serology test to "help them assess a baseline for their community, to understand the prevalence of the virus on their campus, and to be able to make decisions on quarantines and other distance measures for that population that is arriving in mass back on campus."

Both Feeley and Color's Savello said that institutions were less uniform in their strategies around monitoring for infections after the initial comprehensive testing round.

Feeley said that in BioReference's experience, the biggest variable in how schools planned to go about long-term monitoring appeared to be the geography of their campus, with schools within or close to large urban centers – and particularly large urban centers that have high incidence rates – leaning toward more frequent and broader surveillance testing.

"A typical program right now centers around testing substantially all [people] upon return to campus and then maybe a touch point midway through the semester with another program of testing the entire population with the intermediate time really being reserved for symptomatic patients," he said.

Quest Diagnostics and Laboratory Corporation of America are also putting school testing programs in place. Similar to BioReference, Quest spokesperson Kim Gorode said that most schools it is in touch with are interested in an initial comprehensive round of PCR and serology testing, with varying levels of surveillance testing throughout the school year. The company is also exploring the use of self-swabbing sample collection to streamline the process.

Pattie Kushner, LabCorp's chief communications officer, likewise said the company is in discussions with schools around the country about providing testing of students and faculty upon their returns to campus. She said that the company could use the self-sampling SARS-CoV-2 molecular test it offers through its Pixel by LabCorp product to aid with capacity and reduce the need for personal protective equipment.

All four lab firms said they had also been contacted by public and private high schools and elementary schools and districts about possibly providing testing, though all said that their focus for now would be the higher education space.

Meeting the capacity required for such comprehensive testing programs could prove a challenge, said Nathan Ledeboer, medical director of the microbiology laboratory at the Medical College of Wisconsin and Froedtert Hospital.

"As you start to look at the size of these schools, you pretty quickly start to overwhelm the system," he said. "Just the state of Wisconsin, we have about 50,000 students who are in non-state-affiliated universities and schools, and then you're got another 50,000 to 60,000 that are in state-affiliated schools. That 100,000 becomes a very significant number."

Feeley did not directly address whether the company would have the capacity to take on all schools interested in setting up a testing program, but he did suggests that such customers would be less of a priority than the company's traditional hospital and physician clients.

"Our commitment has been and will remain serving our large span of hospital and physician clients, particularly those patients that have a critical testing need," he said. "[Such patients] will always have a spot at the front of our line in the laboratory."

He added, though, that the more predictable nature of school testing demands could make it easier to plan for these customers.

"There will be advance notice for these universities of when their student bases and faculties and staff will return to campus, and so we will have a matter of weeks to properly plan to make sure that there is adequate capacity to service their needs while maintaining our responsibility to the hospital and the critical care needs of our patients," he said. "So, there is some benefit of advanced scheduling with this type of work, and we are going to take full advantage of that."

Capacity could be further strained by rising infections rates throughout the country, as well as demand from workplace and other asymptomatic screening programs as the economy continues to reopen. This week, Quest highlighted these challenges noting that demand for molecular testing has risen by roughly 50 percent over the past three weeks, outpacing increases in capacity.

The company said that this increase in demand would likely push its average molecular test turnaround time to three days. Currently, average turnaround time is one day for high priority patients and two to three days for all other patients. Quest runs 110,000 molecular tests per day and is working to expand capacity to 150,000 tests per day in the near term.

Ledeboer said that his lab is working to develop sequencing-based SARS-CoV-2 testing that he said could be ready to deploy around late August. With this approach the lab could run thousands of tests at a time, but he noted that that the RNA extraction process would still remain a bottleneck. Researchers have developed protocols for extraction-free sequencing-based SARS-CoV-2 tests, but Ledeboer that he was still investigating the performance of those assays.

Beyond testing itself, schools will need to manage and track test results to allow them to make decisions around closings and quarantines, particularly during the surveillance phases of their programs.

Gorode said that Quest would provide data monitoring and analytics as part of its school testing offerings and added that schools would be able to "monitor adherence to their testing program and protocol as well as track both positive and negative results," using the company's Quantym Lab Services Manager portal.

Savello said that Color would be providing institutions with a real-time dashboard of test results.

"We have ways of flagging whenever there is a positive case and then with appropriate HIPAA authorization sharing that individual level data so that [the school] can follow up very rapidly," she said.

Savello said that many of the schools Color has spoken with have plans for "relatively manual contract tracing solutions" for dealing with positive results.

"The key is how quickly and reliably to they get that information," she said. "We treat this as a population-level healthcare delivery questions where we're trying to get that data as quickly as possible and transmit it to them in the simplest format that they can act on."