All day, couriers from the Veteran’s Hospital, Regional One, Methodist and the medical examiner’s office bring small coolers of specimens to what last winter was a glorified broom closet on the fifth floor at 930 Madison Ave.

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Seven months ago, the space at the University of Tennessee Health Science Center campus was transformed into a laboratory that many days processes a third or more of all COVID-19 tests in Shelby County.

And it has the capacity to do more.

“I knew Memphis was underdeveloped for molecular testing. I didn’t realize how desperate this situation was until sometime in February,” said Dr. Neil Hayes, an oncologist at UTHSC and founding member of The Cancer Genome Atlas.

Back then, when it was clear the tsunami was headed this way, he texted a colleague under the table during a meeting: “Should we get into COVID?”

“Yep,” Tim Hodge remembers responding. “And off we went. That was March 1.”

Two weeks later, their team filed for emergency-use authorization from the Food & Drug Administration. By late March, they had assembled tens of thousands of testing kits, put together specimen testing analysis — including writing the script for the robotics — and then honed the whole customer interface element to the point the city could open Tiger Lane, one of the first public testing centers.

“We crushed the labor issues. We have thousands of Ph.Ds. We have many hundreds of students,” Hayes said. “We put out an email, and we had dozens of medical students stuffing kits and aliquoting the product. When you heard everyone in the world couldn’t get kits, we had kits. The health department would show up for kits. We handed them out by the thousands.”

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UTHSC is one of only about a dozen academic centers in the nation to win FDA approval for COVID-19 tests.

For Hayes, renowned cancer physician and researcher, and Hodge, director of pathology for the university’s clinical arm, University Clinical Health, the achievement epitomizes the power of a public university, both because it is layered with talent and nimble enough to innovate. 

“This is the way it is supposed to work. That’s why our public health systems are in place like this,” Hayes said. “In the course of six weeks, we formed a new business with brand-new technology. We skirted around the shortages, and everything here evolved out of the necessity that was presented to us. 

“Private partners couldn’t do this. They did something great too, but they couldn’t develop this from-scratch test,” he said.

“They have a better capital model than we do; they can borrow money, go to the bank and get a loan, but if those reagents aren’t available, there is nothing they can do.”

Novel approach

Testing bogged down in late July in part because Roche, a national supplier, had limited quantities of the reagent needed for analyzing specimens. American Esoteric Laboratories in Shelby County could get only 40% of the supply it needed.

The shortfall coincided with a spike in cases, which meant it was taking a week to 10 days to get test results back.

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“The really important thing to understand is that those ... (testing) instruments are like Coke machines. They can only hold Coke. When they run out, they have nothing else,” Hodge said.

“We said, ‘OK, we’re not going to be beholden to a particular vendor, Roche or Holigic. We are going to build a system that uses basic components that I can buy anywhere.'”

When no one could get viral transport media, for instance, UTHSC made its own. It was completely different from what others were using, the components were readily available, and they also killed the virus, a novel approach.

“Belt and suspenders, we also heat inactivate it,” Hodge said. “Like I told the staff, ‘You may get COVID-19 infection, but you are not going to get it from working here.’”

UTHSC, which also provides and runs the tests for its clinicians, graduate students, staff and patients in its University Clinical Health arm, is running 600-800 tests a day with capacity for hundreds more.

“Obviously, we have a lot of folks that do clinical rotations,” Hayes said. “Some of them have to have tests every 72 hours.”

The beauty of it, Hayes says, if a new strain of coronavirus were discovered tomorrow, the lab could have a new test up and running almost immediately.

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“We would have to go through some of the pain of the regulatory compliance, which I don’t object to. They are there for a reason. But in terms of having a brand-new test, we could have it next week,” he said.

A university that can provide testing for its staff and students is “already fantastic,” said William Buchser, a genetic researcher at Washington University in St. Louis.

But being able to innovate in a crisis is its own marvel, he said.

“Having this other testing option, if Memphis did get to the point where they started filling up beds and running out of other tests – which still could happen – that could be a huge benefit.”

Under Buchser’s direction, Washington University received FDA approval in late August for a PCR saliva test for coronavirus. His team is working on a second saliva test for use in doctors’ offices.

The number of universities that have turned out FDA-approved tests “is in the single digits or slightly higher,” he said.

At Washington U, the work was driven by colleagues and students, he said, wondering what they could do early in the pandemic when much of St. Louis was shut down.

“A bunch of us here got together, ‘If we could make testing cheaper and easier, we could contribute,'” Buchser said.

Dynamic duo

Hayes, the Van Vleet Endowed Professor in Medical Oncology, led the lab at the University of North Carolina that sequenced the RNA in more 20,000 cancer and corresponding normal cells for 33 cancers as part of The Cancer Genome Atlas. That work started in 2006. 

He came to UTHSC in 2017 partly because he could see Memphis was a wide-open market for molecular testing. If he could build it, it would lead to better treatments for cancer patients.

“There is a broad range of needs, which for the most part, Memphis is sending to other labs. Why does Memphis need to send to North Carolina? We can do it right here,” he said.

For more than two years, Hodge and Hayes collaborated on that work.

“The aim all along was for him to take these really sophisticated next-gen assays and put them into the clinical environment for patient care,” Hodge said. “I would guess we were 80% of the way when all this (coronavirus) happened.” 

Hodge’s expertise is equally known. In 2000, he raised enough venture capital to start Transnetyx, a Cordova company that quickly became the No. 1 automated genetic testing company in the nation for laboratory animals.

Researchers from around the world send Transnetyx specimens from mice in their research because they need to know before they start if the mouse has the genetic mutation for the disease they are studying.

“You can’t tell by looking at the mouse,” Hodge said. “They have to be genetically tested to see if the mutation is in there.”

He created the testing system. Twenty years later, he changed the pattern slightly to make the system UTHSC is using for coronavirus.

“It’s extraordinarily similar,” he said.

“We used automation and basically put liquid on it that would turn it into a soup and release the nucleic acid into the solution,” he said. “Then we would clean up the DNA with a metallic bead process, using the same type of molecular probes and the same instruments.”

The next level

UTHSC promises results in 24 hours. Hospitals waiting on results for surgeries hear back in eight. The results flow into their electronic medical records systems.

“For patients tested in the community, turnaround time is 12 hours plus however long it takes us to contact them, which is usually less than 24 hours total,” said Dr. Jon McCullers, senior executive dean of clinical affairs and chief operating officer for UTHSC’s College of Medicine.

A dashboard on an overhead screen in the small lab shows the volume as it flows in, including who the customer is and how far away the courier is. Another screen shows lab turnaround times and positivity rates. Average production on Sept. 1 was 0.35 of 24-hour period – slightly over eight hours – with a 9% positivity or “detection” rate.

“The neat thing about this, it is all modular,” Hodge said, walking through the lab in a calf-length PPE coat and plastic gloves. “So, if we have a bottleneck, we buy one more of these, or one more of those. We don’t have to rewrite the code. We can get it quickly and dovetail it into the informatics.” 

“The biggest part, what you don’t see is the informatics,” he said, pointing to invisible cables hidden behind drop-ceiling tiles. “There’s a tremendous about of data flow between the instruments just to make this work. It’s absolutely critical. It is not the chemistry. It is not the machines. It’s the informatics.”

In a matter of weeks, when a quickly executed expansion is finished, the UTHSC lab will have the horsepower to turn out 2,000 tests a day.

“Oh, absolutely we will need it. There is nothing in the modeling that we will be slowing down one bit,” Hayes said.

In the meantime, the partnership of UTHSC experts, including programmers and informatics gurus, have built interfaces to work with each customer’s IT system so samples are tracked without a hitch from the point of collection through specimen analysis, which takes about five hours, “from soup to nuts,” Hodge says.

Ultimately, the same interface sends the results to the patient and state health department.

“Any sample confusion of any kind is unacceptable,” Hayes said. “It may just be one tube, but if you have a tube lost in a haystack of a thousand tubes, you have a haystack problem, not a tube problem. We know that.”

UTHSC on its own could not offer broad care for the public. But University Clinical Health could. It also does the billing, which a state-run university could not do.

“We are still taking an overall loss because of the high startup and now, the expansion costs,” McCullers said.

He expects it will break even in a year.

By working together, the university entities launched a testing program with broad enough ramifications that the City of Memphis has backed its work.

“We were involved heavily with the city. They are part of this expansion initiative,” Hayes said. “Schools are back in session. There are other things that initially weren’t in play that are now, like surgery centers and nursing homes. Some of this is still evolving, but the market is not shrinking.” 

The next improvement will give patients and clinicians a way to track their specimens through the process, from the time the sample is taken to to when it queues up for reporting.

“People want to know where their stuff is,” Hodge says with a smile.

“Pathology, at its heart, is to serve the clinician, who can then serve the patient. We want to make it the best possible client experience.”