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National Labs Launch SARS-CoV-2 Testing, But Questions About Demand Complicate Planning

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NEW YORK – A number of national reference labs over the past week launched testing for coronavirus COVID-19, the disease caused by SARS-CoV-2 virus, but many are still weeks away from having the capacity to test on the order of tens of thousands of tests per week.

Additionally, a lack of clarity regarding how much demand for SARS-CoV-2 testing there will ultimately be presents challenges for labs in terms of deciding whether and when to order the additional instrumentation that could be needed to expand testing capacities.

Quest Diagnostics began testing this week at its facility in San Juan Capistrano, California and expects to have performed several thousand tests by the end of the week, said Rachel Carr, a spokesperson for the company. She added that the company is now expanding testing capacities at other laboratories and that it anticipates within six weeks being able to run tens of thousands of tests per week.

Laboratory Corporation of America launched testing last week and is currently able to perform several thousand tests per day, said Pattie Kushner, the firm's vice president and chief communications officer, adding that that figures includes testing done using both the assay developed by the Centers for Disease Control and Prevention and a LabCorp-developed assay.

She said that the company "is rapidly adding new equipment and staff to create additional capacity" and that it continues to "review all opportunities to expand testing at LabCorp lab facilities across the country."

Jon Cohen, executive chairman of BioReference Laboratories, part of Opko Health, said his lab would begin running SARS-CoV-2 tests within the next 24 hours, starting with throughput of several hundred tests per day and expanding to "a couple of thousand" per day next week, "and then from there to 5,000 to 10,000 per day."

He said the company would be running the CDC assay along with assays on at least two other platforms and possibly three.

"We're scaling on multiple platforms which are much more automated, with auto-extraction, and a larger number of wells," compared to the testing platforms currently in use, he said.

Cohen said he believed that "within the next couple weeks" BioReference would have the testing capacity it needed to meet demand.

However, he noted, testing demand is something of a moving target, with the potential for labs to need to add more capacity as demand continues to rise.

"That is actually what I think the dilemma is for a lot of the commercial labs or really anybody doing this," Cohen said. "Because despite what everybody tells you, nobody knows what the demand is [ultimately] going to be right now."

Clients have been calling, saying they currently need X number of tests to be performed, but if they need to scale up, would BioReference have the capacity. "Those are the kinds of questions I'm getting," he said.

He recalled a recent conversation he had with a large medical group client. He asked the client what he thought his testing demand would be in the future.

"And his answer was, 'I don't know. I just want to know if I need the testing that you'll be able to provide it,'" Cohen said. When he asked whether that meant 10 tests a day, 100 a day, or even 1,000 a day, the client's answer was "I don't know."

Adding capacity isn't something that can be done overnight, noted Robert Boorstein, medical director for oncology and esoteric testing at Brooklyn, New York-based Lenco Diagnostic Laboratories. Even if an assay has been validated and is up and running, if additional instrumentation is required to meet demand, getting a hold of that instrumentation can take weeks to months.

He gave the example of the CDC assay which he said runs on an Applied Biosystems 7500 Fast Dx instrument from Thermo Fisher Scientific.

"Say you're running [the test] on one or two of those instruments. You can't just go and buy 10 more," he said, noting that out of curiosity he recently asked the company how long it would take to ship a 7500 Fast Dx if he placed an order. The answer was one month.

Cohen said he didn't know how long it would take the vendors BioReference is working with to ship instruments if the lab decided it needed additional ones to expand capacity.

"The answer from each one of them would be different," he said.

He said the company could also expand capacity by starting testing out of its other facilities around the country, some of which have the necessary instrumentation in place. Currently, all SARS-CoV-2 testing is being done out of BioReference's Elmwood Park, New Jersey lab.

Boorstein said that Lenco planned to begin testing as one of the 28 private labs New York Governor Andrew Cuomo asked on Wednesday to launch testing. Boorstein said he believed Cuomo's request stemmed in part from concerns that national reference labs would not have enough capacity to meet SARS-CoV-2 testing demand.

Boorstein said Lenco was taking a three-part strategy to testing. The first component was to get testing up and running on the Hologic Panther Fusion systems it has in place. He said the lab was currently waiting to receive reagents after which it will be able to do validation in several days and then start testing at a rate of around 1,000 tests a day. He said they could triple that volume by adding Fusion modules but that this would probably take additional months.

Lenco also plans to implement an assay using BioFire's Torch system as soon as reagents are available.

The company also has the equipment necessary to perform the manual assay currently in broad use but no source of reagents or validation samples, Boorstein said. "We're trying to work with the state. If they want us to bring [the test out] on that platform, then we need their assistance in getting reagents and validation samples."

Cohen said that BioReference's decision to use multiple vendors' platforms for testing was in part a hedge against potential issues with reagent supply chains.

"I want to make sure I'm not dependent on one vendor right now because of the supply chain side," he said.