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Vox deemed April, just as the country was on the cusp of an enormous increase in testing, a "lost month." The publication interviewed an expert who insisted, "Testing is not going to be resolved until the federal government takes ownership of expanding it; as long as they keep kicking it to the states, we will remain stuck."

(The day the piece was published, the U.S. performed 273,000 tests; a little more than a week later, it performed more than 360,000.)

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Testing is reliant on a complicated ecosystem prone to disruption at any number of places. If there aren't enough swabs, samples can't be collected. If there isn't enough personal protective equipment, personnel can't be protected while collecting samples. It there aren't enough tubes or transport media, the samples can't be sent out to be tested. If there aren't enough reagents the chemicals necessary to detect the virus the tests can't be run. It doesn't matter if most of the components are in ample supply if there's a shortage in one of them.

There are a couple of types of tests. Molecular tests, the workhorse on COVID-19, identify the genetic material of the virus during an active infection; antigen tests, not nearly as prevalent, look for specific proteins on the surface of the virus, also during an active infection; and serological tests identify antibodies to the virus in the blood, indicating a past infection.

On top of that, there is a variety of different molecular tests. There are lab-developed tests, which are what they sound like tests developed by commercial labs like Quest or LabCorp. The labs process these tests themselves from samples coming from hospitals, physician offices, urgent-care clinics, and mobile sites. These were the first tests available other than what came from the CDC.

Then, there are the diagnostic manufacturers, companies like Hologic, Roche, Abbott, and Thermo Fisher, that develop test kits that can be run on their specific machines, which are at hospitals and labs.
There are also point-of-care tests, where the sample is taken and the test is run, at the same place.
And, finally, at-home collection kits have been developed.

The diversity of platforms is ultimately a strength, but it makes for a mosaic where everything has to be matched e.g., it does no one any good to have a Roche machine if there isn't a Roche test available to run on it.

Working through this complexity was one of the challenges of boosting testing to another level.

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In early March, the White House called leaders of the diagnostic manufacturers and the commercial labs to talk about scaling up. Dr. Deborah Birx, the White House coronavirus-response coordinator, describes it as "really a call to action by the president and vice president to say very clearly, 'We need enhanced and greater diagnostic laboratory capacity. You are the private sector that have the technical ability to do this.'"

It coincided, weeks later, with the first big bump in testing.

Scott Whitaker, the CEO of the medical-technology association AdvaMed, explains the progression, from the first lift in numbers in March to the plateau in April to the recent sharp increase: "You get a handful of companies that were quick to the gate, and you started running all those tests on the machines that they had available with the labs. The next round comes in and scales up even more dramatically on the high-throughput machines," machines capable of running a lot of tests quickly.

"And," he continues, "that's when it started to take off again."

A key event was the FDA's acting to clear away in late February the hurdles for commercial labs to begin offering tests. Within days, labs were ready to accept specimens, and they have ramped up ever since. By March 22, the labs that are part of the American Clinical Laboratory Association, encompassing the big players in the industry, had collectively performed 200,000 tests; by the end of May, they were consistently performing more than 200,000 a day.

"Even for the larger players," a lab industry insider explains, "the LabCorps and the Quests, they were able to bring it online at one of their labs, say. And then it's just gradual, that expanding out." As the shortage of supplies and backlogs from the pent-up demand for testing were worked through, the testing reached a different level, and "then the issue became actually unused capacity."

Meanwhile, the Trump team worked to see that every component necessary to testing was being manufactured.

It put in big orders to assure companies that they'd have a customer if they drastically scaled up production. It went to new players to get them to pitch in Oak Ridge National Laboratory started making metal molds for plastic tubes, and Coca-Cola started making tubes. It cleared the way to use sterile saline, much easier to procure than traditional transport media, for some tests. It got a so-called fill-finish company to begin putting transport media, instead of its usual injectable vaccines, in vials.
And so on, all across the supply chain.

The DPA was a tool, but not the main event. The act can be usefully deployed to rate orders and move the government to the front of the line, and to make investments in companies to increase their production. No one thought that using it to nationalize industry or take over supply chains made sense.

Giroir calls that idea "absolutely insane." He asks, "Why would we buy it all up, bring it to a warehouse in FEMA, and try to redistribute it, when they've got mature distribution chains that they use every single day throughout the country?"

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The experience of Hologic, a major player in this space, shows how we've got to a different place on testing. The company is focused on women's-health diagnostic and medical-device products. Along with Roche, it is the leader in molecular diagnostics. Its state-of-the-art machines are called the Panther and the Panther Fusion, which attaches to the Panther.

According to Hologic's CEO, Stephen MacMillan, early on a couple of its scientists focused on the outbreak in China, including one with family in Wuhan, and encouraged the development of a test even when the CDC said it was going to be taking the lead. "So we, in a skunkworks way," says MacMillan, "started working on developing, effectively, our first test, which goes in our Panther Fusion. It leverages a lot of the flu-testing technology that we use, and there was a clear pathway for approval."

That got approved in late March. "At that point," he says, "we were getting inundated with calls from governors, customers, everybody, and including a whole bunch of world leaders saying, Can we help them?"

Hologic could make about 600,000 of the test per month, which was much more than the number of its flu test, at about 50,000 a month. But it realized that the demand was going to be bigger.

It began work on a higher-volume test using a form of nucleic-acid testing. It got approved in early May, and Hologic is making about a million of the tests a week. It runs on its high-throughput Panther platform. There are 1,000 Panthers installed in the United States, and each of them can run 1,000 tests a day. Results are available within a couple of hours.

MacMillan says that the first shipment of this second, high-volume test went to hundreds of labs and hospitals around the country in late April and that it was coordinated with the coronavirus task force to put a special emphasis on hotspots. "That's where things really kicked up in May," he says of the overall testing number. "I think it's as we started to get really major volume on high-throughput instruments around the country." And, of course, as he notes, "other companies were ramping up capacity as well."

The innovation around a new test is complex, using the reagents to identify a strand of DNA, developing the software to program the Panther machines to run the tests, making sure it all works and is accurate.

"We'll do it in the lab, where we'll inject the tube with the actual virus," MacMillan says. "We'll then run our tests through it, and we'll make sure, Are we getting it when we know there's the virus in it? Also, are we not ruling it out when it's not?"

"Literally, our R&D team, they were working through the weekends. We had R&D people coming in at three in the morning on Fridays, Saturdays, and Sundays," he continues. "They put the tests going in before they leave work and it would be running, and they'd come back in as soon as it was coming off."

"We've committed that we'll provide at least a million tests a week, from here going forward. We are scaling additional capacity, to be able to provide even more than that. We haven't stated it publicly yet, but e by September we'll be delivering well over a million a week, should the country need it."

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