Skip to main content
Premium Trial:

Request an Annual Quote

Flush With $10B From Biden Administration, SARS-CoV-2 Testing in K-12 Schools Poised to Escalate


NEW YORK — With the federal government recently announcing billions of dollars in funding for SARS-CoV-2 testing in K-12 schools, clinical laboratories, vendors, and various other institutions are ramping up efforts to roll out school screening programs.

While the role of testing in reopening schools has received attention throughout the pandemic, the Biden administration's move last month to provide through the American Rescue Plan Act (ARPA) $10 billion in funding for school SARS-CoV-2 screening has accelerated such efforts.

"I think there's really no question when you think about schools, since they operate off [local] tax bases, and there have been a lot of funding issues for a lot of city, state, local programs… that the government responding [with funding] has …made schools much more proactive about [testing]," said Chris Mahl, executive vice president and chief revenue officer for lab robotics firm Opentrons Labworks. The company announced last month it was launching labs in New York, Washington D.C,, Los Angeles, and Seattle focused on K-12 testing through its SARS-CoV-2 testing business, Pandemic Response Lab.

Opentrons Labworks was one of several to announce school testing plans in the wake of the ARPA funding. Thermo Fisher Scientific and Color Health announced in March that they were partnering to launch a school SARS-CoV-2 testing program. Gingko Bioworks likewise announced agreements with Dascena Labs, Olive Labs and CQuentia to provide testing to K-12 schools, and Opko Health subsidiary BioReference Laboratories, which has been providing testing for New York City schools since October, announced that it was expanding its SARS-CoV-2 testing program to reach schools across the country.

At the same time, commercialization of rapid antigen tests for asymptomatic screening has picked up steam with this week Quidel, Abbott, and Becton Dickinson receiving US Food and Drug Administration Emergency Use Authorization for tests intended for use in serial testing of asymptomatic individuals.

Companies including Ortho-Clinical Diagnostics and Beckman Coulter are also rolling out lab-based antigen tests that could potentially provide an alternative or backup to molecular assays for school testing.

In an effort to help bring the country's testing resources to bear on the challenge of school testing, the Rockefeller Foundation last week released its K-12 National Testing Action Program (NTAP). The program aims to provide guidance on SARS-CoV-2 testing for schools and to connect schools with laboratories and manufacturers that can facilitate testing.

Mara Aspinall, professor of practice, biomedical diagnostics at Arizona State University, as well as the former president of CEO of Roche's Ventana Medical Systems and an advisor to the Rockefeller Foundation, said that data from school testing pilot projects supported by Rockefeller and other organizations indicated that schools have not been a major source of SARS-CoV-2 transmission. This, combined with the Biden administration's prioritization of in-person schooling and data indicating that in-person learning is more effective than virtual schooling led the foundation to draw up its testing guidelines.

"We realized that when you look at how to [return to in-person schooling] in a safe and sustainable way, testing is the missing link," Aspinall said. "Tests are the way to get the data to understand how [in-person school] is working and if there is anyone who needs to be isolated.

"So, we created a system with guidelines and a protocol for how testing can be effectively done," she said.

The Rockefeller plan calls for all participating students to be tested once a week and all participating teachers and staff to be tested twice a week. Aspinall said that the plan is technology agnostic, but added that different assays may be more or less appropriate for different settings. For instance, she noted that while many school screening programs make extensive use of molecular test pooling, schools in high-prevalence areas may decide to start with individual molecular tests. Schools without good access to labs with molecular testing capabilities may opt for rapid antigen testing instead, she said, though she added that she believed with the NTAP report, Rockefeller had highlighted providers that could ensure 24-hour turnaround of results to most locations across the country.

Another consideration, Aspinall said, is how schools prefer to handle the sample collection process. In the case of molecular testing, an entire school can collect swabs simultaneously from all students at one point in time, whereas rapid antigen testing, particularly if the test is instrument-based, may need to be done classroom-by-classroom over the course of a school day given the sequential nature of this testing.

In addition to testing protocols, the Rockefeller report provides contact information for nearly 30 test vendors or labs that schools can work with to implement testing programs. The list includes major reference labs like Laboratory Corporation of America, Quest Diagnostics, and Sonic Healthcare along with test develops like Abbott, BD, and Quidel.

Just as labs and vendors have in recent weeks placed new emphasis on school testing, schools have recently shown a significant uptick in interest around testing, Aspinall said.

"What we have seen is that over the last few weeks, the interest from schools to test has skyrocketed," she said. "Even before the formal publishing of [the Rockefeller report] schools and districts were reaching out to testing companies to get [programs] established."

She noted that in some districts, including large urban districts like Los Angeles and Chicago, teacher union contracts call for regular testing.

Labs and manufacturers have been able to set up testing programs with schools in around 10 days, Aspinall said, noting that the experience and infrastructure gained over the last year in SARS-CoV-2 testing in schools and other settings has helped streamline the process.

"It's not the beginning of testing for labs and manufacturers," she said. "The systems work pretty well now where labs and testing companies can some it and set something up, get consents, get the school roster and have it functional in 10 days to two weeks."

"We've been supplying our TaqPath kits to thousands of labs across the country," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "We ship about 10 million test kits per week."

Addressing school testing has meant shifting from a product aimed at symptomatic testing to asymptomatic screening, he said.

But while this required developing a new pooled qPCR test, "we obviously have a supply chain behind it that we can use to scale," Stevenson said.

Thermo Fisher has partnered with Color Health to handle software for the registration of students, sample tracking, and sample processing, while Thermo Fisher is providing the barcoded test kits. Schools will handle sampling of students and staff and then send those samples to labs running the TaqPath test.

Stevenson said that around 1,000 labs across the country are currently using the company's equipment and kits for SARS-CoV-2 testing.

"Typically the school district that wants to set up testing will contact us, and Thermo Fisher will set up the program for them to do testing and set up the software enrollment using the Color interface, set up the shipping of the kits out to them, and then the kits, depending on where the school is, will come back to the right lab, geographically," he said.

New York City-based Opentrons Labworks is expanding its Pandemic Response Lab (PRL) SARS-CoV-2 testing business by building new facilities in Washington D.C,, and Pasadena, California to facilitate K-12 screening. Originally a lab robotics company, Opentrons moved into SARS-CoV-2 testing last year when it opened its Pandemic Response Lab in New York to help address the state's SARS-CoV-2 testing deficit.

The company applied its lab robotics systems to building a "high-throughput, super sensitive, very miniaturized" SARS-CoV-2 testing process, said Mahl, noting that it has run about 2.5 million tests out of its New York lab since September.

The company recently announced the launch of a school surveillance testing line that tests samples in pools of 25 at a cost of a dollar per sample.

Mahl said that PRL was working with companies like Gingko Bioworks and Centricity and Cambridge Innovation Center that handle the front end of school testing to do the actual running of the test samples. He said that between its New York, D.C., and Pasadena locations it could provide 24 hour turnaround to roughly 60 percent of the country and that it planned to add new locations to expand its reach.

Pooled PCR testing has been the most widely used mode for school surveillance testing, but rapid antigen testing has also found a role in some programs. Delaware, for instance, has run a school testing program that, according to the NTAP report, uses BD antigen testing for screening and is currently operating in around 75 public schools across the state. Massachusetts' school screening program uses rapid antigen testing to follow up tests of positive pools.

Vendors of lab-based antigen testing like Ortho Clinical and Beckman Coulter are positioning those tests as potential screening tools, as well. Chris Hagen, vice president, global marketing for Beckman Coulter, suggested that lab-based antigen tests are more scalable than point-of-care assays and can be faster and less expensive than molecular assays. Beckman Coulter's Access SARS-CoV-2 antigen test, for instance, can be processed at a rate of 200 samples per hour, while Ortho Clinical's Vitros SARS-CoV-2 antigen test can be processed at 130 per hour.

Beckman Coulter can currently ship around 25 million tests per month while Ortho Clinical said this week it has received a $53.7 million contract from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and the US Department of Defense (DoD) to ramp up production of its COVID-19 antibody and antigen tests to 6.7 million per month.

Those figures suggest lab-based antigen testing could help fill the capacity gaps left unmet by molecular assays.

"If you look at the Biden administration plan to look at K-12 and universities and really open up the economy through systematically testing every single student once a week, there's nowhere near the PCR to meet that need," Hagen said. "That is where the antigen [tests are] going to play a role, those are the customers we are speaking with."

There are roughly 56 million K-12 students in the US, which means that to test each one per week would require around 220 million tests per month. That figure outstrips the current 115 million-per-month molecular test capacity estimated in a recent report authored by Aspinall and colleagues as a collaboration between COVID-19 Response Advisors & Health Catalysts Group, and much of that capacity is already going toward demand from areas other than school surveillance.

Aspinall said, though, that she believed the country would have the capacity to handle school surveillance demand — and largely through molecular testing. She pointed to pooling as one of the most important factors in meeting demand.

Labs like PRL are pooling upward of 20 samples per test, while Massachusetts' school testing program, which Aspinall noted is very similar to the NTAP guidelines, has averaged pools of seven samples per test.

Aspinall also noted that not all schools would implement testing and not all students would take part in testing programs.

"There's not going to be 100 percent uptake," she said. "We assumed in the NTAP numbers 60 percent uptake. We'll see what that looks like in reality, but we know there are several states where people have gone back to school without significant outbreaks and they are not testing. Many of those will not test, and within a school, virtually every district has called testing optional."