May 2020 Cover Story: ‘Let’s Go Save Some Lives’

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Posted By on May 7, 2020

ASU pivots to fight COVID-19

In late January, when an Arizona State University student was diagnosed with Arizona’s first case of the novel coronavirus, our state woke up to the realities ofCOVID-19. Arizona was not well prepared to deal with the threat. Testing nationwide was limited, plagued by shortages of testing kits and reagents. ASU President Michael Crow was faced with having 90,000 students and no medical school. How could he make sure students could get testing if they needed it?

Dr. Joshua LaBaer had an idea. LaBaer is one of the country’s premier investigators in the field of personalized diagnostics. Formerly the founder and director of the Harvard Institute of Proteomics, he was recruited to ASU’s Biodesign Institute as the first Virginia G. Piper Chair of Personalized Medicine in 2009 and is the executive director of the Biodesign Institute today.

LaBaer realized he had a secret weapon at his disposal: his lab’s previous contract with the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA. As part of that $39 million project, LaBaer’s team had developed a diagnostic assay for assessing exposure to radiation. “Imagine if a nuclear bomb went off in a major American city and civilians were exposed to gamma radiation. There would not be an easy way to determine who had been exposed and how much radiation they had been exposed to,” LaBaer said. “We developed an assay to assess gene expression in the white blood cells in a manner that would predict radiation dose.”

Part of that multi-year project required LaBaer’s lab to automate their method and demonstrate that they could do 2,400 assays in a 24-hour window. As a result, they had the robots and other automation in place. Now, if they just swapped the genes related to radiation for coronavirus ones, they would be ready to do viral testing.

After LaBaer’s realization in mid-March, he convened a team of six for daily phone calls to get testing off the ground. It has since snowballed so that those calls now include more than 50 people.

“Back then, it was just, could we do the test? Then I realized, well, if we’re going to do the test, we’re going to have to have sample collection,” LaBaer said. After talking to several Arizona hospitals, LaBaer learned that supply chain shortages meant there were just a couple thousand kits in the entire state.

“Some hospitals were saying they had 200 kits total,” LaBaer said. “So I said, ‘You know what, we’re a university. We know how to make this stuff.’” Staff and students sprang into action and have assembled more than 15,000 testing kits to date.

With kits in place, ASU stepped up to collect specimens. Katherine Kenny, the associate dean of academic affairs at ASU’s Edson College of Nursing and Health Innovation, met with LaBaer’s team on March 29 to come up with logistics and procedures. They opened up drive-through testing three days later. “In normal times, if somebody wanted to set up a health screening of any type, it would take meetings and committees and legal approval that could take months. Here, there was a level of respect, understanding and dedication that was just magnificent,” Kenny said.

All of Edson College’s faculty are registered nurses, and many were thrilled to have a chance to serve. In fact, as the chief nurse of this operation, Kenny realized it would be a valuable opportunity for students, too. So she got permission from the provost and President Crow that for this one effort, they could include doctoral students preparing to be nurse practitioners as well as undergraduate nursing students in their last semester before graduation.

Kenny sees it as a once-in-a-lifetime event. “The students participating see their faculty in action with them,” she said. “It is an experience that I hope they never have to see again in their career — I mean, the last pandemic was 1918. But it’s an amazing public health event to serve the community.”

Edson College faculty and students have become incredibly efficient at the procedure. “We can collect a specimen — including drive-up and drive-away — in less than two and a half minutes,” Kenny said. “It’s thanks to the spirit of continuous quality improvement. We review every day, put it in writing, and the next day we make the change.”

This can-do attitude also allowed LaBaer and the Biodesign Institute to retool their lab rapidly. “As a clinician and a doctor, and also one who does diagnostics, I realized I was going to need CLIA certification for this,” LaBaer said. The Clinical Laboratory Improvement Amendments (CLIA) govern lab testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services before they can accept human samples for diagnostic testing.

LaBaer not only navigated complex federal regulations to gain CLIA certification, but he also got the lab cleared by the FDA and got emergency-use authorization. “We got fully certified to do everything,” he said.

Next came tweaking their molecular-biology protocols. “We had to get all of our equipment into a single room under a separate lock and key because we’re dealing with clinical samples that, in theory, could carry live virus,” LaBaer said. Only certain people are allowed in and out of that room so that it’s safer for the university and everybody in it. They also had to develop automation, train personnel, work out how to transfer samples from collection kits to the tubes used to run assays, and how to check bar codes to ensure two forms of identification at every step. Biodesign Institute scientists got this all set up in four weeks.

The Biodesign Institute’s high-throughput platform uses specialized robots to process samples, allowing it to get results faster than state and hospital labs, where tests are usually processed by hand. Plus, robots can read results for multiple samples at the same time, allowing ASU to complete hundreds of tests a day. (The lab promises results in 48 hours, but so far, from the moment they get the sample to the moment they deliver the answer, they are averaging under 24 hours.)

LaBaer said they are currently analyzing about 400 samples a day, gathered from people experiencing COVID-19 symptoms who have been seen at various healthcare facilities or their drive-through sites. “The entire process, start to finish, is done by robots, which means that without even taking a deep breath, we can do 400 samples a day. It would not take much to expand that to round-the-clock testing to analyze well over 1,000 samples a day if needed,” LaBaer said.

Even with the headstart the BARDA project allowed, gearing up for high-speed coronavirus testing has not been easy or inexpensive. The supplies, implementation and staffing are costly. Plus, LaBaer and his team realized that if demand for testing were to increase dramatically, they would be dead in the water if one of their instruments went down.

Fortunately, the Virginia G. Piper Charitable trust made a $2 million emergency grant to boost ASU’s COVID-19 preparedness in several areas: testing healthcare workers, first responders and other people with essential jobs; assembling nose and throat swab test kits for healthcare providers; and manufacturing personal protective equipment such as face shields through 3D printing.

“Frankly, we had no idea where we were going to get support,” LaBaer said. “So, they stepped up in a huge way.” Piper Trust’s funding helped to cover the cost of equipment, supplies and personnel time. It also helped to purchase a second robot to prepare solutions and process and test samples. “Everything we have now is duplicated, so if any one thing went down, sure, it would slow us down, but it would not stop us,” LaBaer said.

It takes a group of three individuals to run the lab each day, but the Bioscience Institute is onboarding more teams in case the demand for testing increases. “The idea is to have several such teams that never see each other in person so that no team can infect the other teams if they were to get infected,” LaBaer said. The goal is to use testing to keep doctors, nurses and other first responders free of disease so they can continue to care for others safely. If the lab had to go to a 24-hour operation, with multiple teams, it could probably do north of 2,000 assays a day. “With the automation, it’s very scalable,” LaBaer said.

Also scalable is ASU’s university-wide response to the coronavirus crisis. More than 100 labs across the university are involved as well as engineers who have ramped up a massive initiative to design, produce and distribute personal protective equipment and other medical supplies such as swabs and face shields that are already being used by ASU Health Services and medical facilities around the Valley.

The level of volunteerism has been impressive as well. A few weeks back, people on LaBaer’s morning call said they needed help. So they sent out an email to the Biodesign Institute and within five hours had more than 200 volunteers. A few days later, after folks shared the message, they had more than 600. “We’re getting overwhelming response,” LaBaer said. “It’s very, very cool how many people want to help out.”

For now, LaBaer sees testing as the most critical thing that can be done to save lives in our community. It’s how you “see” the scale of the current pandemic, and right now, we’re largely blind. “One challenge with this particular virus is that there is mounting evidence that people are infectious before they get symptoms. That’s why we have to do what’s called contact tracing,” LaBaer said. If we are aggressive about testing people who are symptomatic and then if we’re also aggressive about testing all of the people that they’ve been in contact with, we can start to get a handle on the disease.

“Our focus right now is about getting the state back to normalcy. How do we get people back to work in a way that doesn’t let this whole thing get out again? I think the key is testing,” LaBaer said.

In addition to coronavirus testing, LaBaer’s Biodesign Institute team is also in the early stages of developing a blood test for all seven strains of coronavirus. “We might as well test all of them, because it may turn out that people who’ve had a coronavirus cold before have a little bit better outcome than people who’ve never had it at all,” he said.

This will aid vaccine development efforts, help detect asymptomatic carriers and help understand why some people get very sick while others have no symptoms from a COVID-19 infection.

Meanwhile, ASU professor Brenda Hogue, who is an expert on coronaviruses; molecular biologist Qiang “Shawn” Chen; and virologist Bert Jacobs are working on developing their own coronavirus vaccines using different techniques.

“We want to help, if we can,” LaBaer said.

As the first month of drive-through COVID-19 testing is complete, Kathy Kenny is journaling about the experience for the college history book. “We have had some faculty there every single day. The pride of being a registered nurse and seeing the service-oriented faculty has been really meaningful to us,” she said. “I’m hoping that for every nurse, student and graduate we’re touching, there will be 10,000 people impacted by that through their career, and that they will understand what it means to serve.”

That culture of service reverberates throughout the ASU community as faculty, staff and students come together for a common purpose. One of the most poignant comments came from a security officer who helped with the coronavirus drive-through testing lines. As Kenny explained, “He said, ‘You guys are nurses, and you impact people’s health. But never in my life did I think I would have the privilege of helping employees of my company stay healthy.’”

ASU has been ranked the most innovative school in the U.S. by U.S. News and World Report for five years running, and the university’s response to coronavirus shows why. In a matter of weeks, the school shifted its research capabilities to have a CLIA-certified clinical test with a database and collections facilities. It’s working on getting contact tracing up and running as well as a vaccine to prevent COVID-19. “The Biodesign Institute was set up to be a transdisciplinary institute that engaged people from many different disciplines to solve real-world problems. And that’s exactly what we’ve done here,” LaBaer said. “We’re pulling together molecular biologists, automation specialists, database specialists, operations team specialists and others into one group to say, ‘How do we make this happen?’ And we did it in four weeks.”

In many ways, almost all of LaBaer’s training has led to this moment. He is a physician who has done a lot of research on infectious disease. Much of his history has been in diagnostics, but he also knows automation and databases. “A lot of what I do has built the skills I need to help out here,” he said.

A few weeks ago, when LaBaer began having daily phone calls with colleagues to address how ASU could pivot their work to fight COVID-19, he ended the call by saying, “Let’s go save some lives.” Then he stopped saying it a couple of times.

“People said, ‘You’ve got to say that every time!’ So we say that at the end of every call,” he said.

And then they go out and do just that.

To learn more, go to biodesign.asu.edu

Karen Werner

About Karen Werner

Karen Werner is the editor of Frontdoors Media. She is a writer, editor and media consultant. She has interned at The New Yorker, worked at Parents Magazine, edited five books and founded several local magazines. Her work has appeared in Sunset, Mental Floss and the Saturday Evening Post.