Virginia Tech scientists have developed a new COVID-19 test and secured federal and state approvals to begin processing samples at on-campus labs in Blacksburg and Roanoke.

The university will support local health departments throughout the region to provide timely analysis to identify patients suspected of having COVID-19 — a critical step in the process of slowing the pandemic in Virginia. No patient samples will be collected at either of the labs — that step is done by health departments or health systems working with health departments, including the Schiffert Student Health Center at Virginia Tech.

“Virginia Tech has received emergency permission to begin testing COVID-19 samples and we have notified local health departments that we are ready to begin receiving samples soon,” said Michael Friedlander, executive director of the Fralin Biomedical Research Institute at VTC and Virginia Tech’s vice president of health sciences and technology. “With expanded testing becoming crucial to controlling the pandemic, in Virginia and the nation, Virginia Tech faculty, staff and graduate students went to work to answer the challenge.”

The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization on Monday for the university to proceed with testing. FDA review of the validation is pending. After review, the university will receive official notice as to whether full FDA approval is granted.   

Virginia Tech scientists (from left) Harald Sontheimer, Dipan Patel, Bhanu Tewari, Thomas Maynard, Robyn Umans, Joelle Martin, Carmen Muñoz Ballester, and Michael Friedlander discuss steps to utilize lab space for COVID-19 testing assays at the Fralin Biomedical Research Institute at VTC.

COVID researchers
Virginia Tech scientists plan labs for COVID-19 testing at the Fralin Biomedical Research Institute in Roanoke. Harald Sontheimer (left), a faculty member at the research institute and a professor of neuroscience in the College of Science, and Michael Friedlander (right), executive director at the Fralin Biomedical Research Institute, say test results will be returned to health departments within 24 hours. Dipan Patel (second from left), Bhanu Tewari, Thomas Maynard, Robyn Umans, Joelle Martin, and Carmen Muñoz Ballester have worked to finalize testing protocols while practicing social distancing at the Roanoke site.

With hospitals challenged by shortages of critical resources and diagnostic labs glutted with potential COVID-19 samples, scientists with both the Fralin Biomedical Research Institute in Roanoke and the Fralin Life Sciences Institute in Blacksburg confronted the problem.

“We were alarmed that the backlogs at testing labs seemed to be growing without much relief, which makes it difficult to treat patients appropriately and to contain the pandemic guided by timely, accurate data,” Friedlander said. “With so many scientists at the forefront of biomedical technology, facilities, and expertise — we were confident our teams could develop assays and make a meaningful contribution.”

Faculty research leaders and their teams, led primarily by Carla Finkielstein at the Fralin Life Sciences Institute in Blacksburg and also by Harald Sontheimer at the Fralin Biomedical Research Institute in Roanoke, noticed the hardship and jumped into action.  

“Everyone is helping in any way that they can from their positions at the university,” said Finkielstein, an associate professor of biological sciences in the College of Science and affiliated faculty member of the Fralin Life Sciences Institute. “It amazes me; it is a true team effort.”

All the analysis will be done in a standardized, safe manner under the certifications and guidelines of university, state, and federal oversight. The final approvals to conduct the tests came this week after weeks of stressful, round-the-clock work to overcome multiple hurdles.

The challenge of completing work quickly was magnified because access to critical reagents were in short supply and aligning instrumentation and protocols with state and federally mandated guidelines was a complex process. 

“Despite the obstacles, Dr. Finkielstein rolled up her sleeves, went into her lab, and started cranking,” Friedlander said.  “Carla is a non-stop force of nature with the compassion for service to others to match her grit and scientific acumen. She and her fantastic team of postdoctoral fellows have been working tirelessly ever since.”  

Sontheimer, the director of the Center for Glial Biology in Health, Disease, and Cancer at the Fralin Biomedical Research Institute, and executive director of Virginia Tech’s School of Neuroscience in the College of Science, and his group of postdoctoral associates, technicians, and graduate research assistants used their experience in molecular biology and molecular virology to work closely and in parallel with Finkielstein’s team developing the assay and preparing the protocols for implementation at the Fralin Biomedical Research Institute in Roanoke.

All eight members of Sontheimer’s lab are devoting their attention to the effort, while postdoctoral fellows and research associates are working back and forth between Roanoke and Blacksburg, sharing information.

“In Roanoke, we couldn’t have done it without Robyn Umans of the Sontheimer lab and Carmen Munoz Ballester of Dr. Stefanie Robel’s lab,” Friedlander said. “They and their colleagues are true heroes, completely dedicated — Carmen has been working around the clock and trains others in the techniques she has helped perfect – and she is expecting a baby in a couple of weeks on top of that.”

Loading player for https://video.vt.edu/media/Virginia+Tech+researchers+develop+new+COVID-19+tests+to+combat+backlogs%2C+shortages/1_4465y9wb...

“This effort is the result of very purposeful support by Virginia Tech Provost and Executive Vice President Cyril Clarke to muster the university’s biomedical expertise against the pandemic,” Friedlander said. “His support has been key to our timely forward movement and tackling the scientific and regulatory challenges head on.”

Friedlander and Matt Hulver, the executive director of the Fralin Life Sciences Institute, pressed forward to make arrangements to reconfigure lab space for Virginia Tech scientists to process COVID-19 samples in Roanoke and Blacksburg,

“Many faculty members stepped outside of their normal roles and routines, but ultimately these people are scientists who are at the top of their game,” Hulver said. “We realized this testing uses technologies that many of us have available in our labs, and we could be part of the solution. We have robotic equipment. Our scientists understand biomedical research. We have software. We have safety training. It’s what we do.”

Meanwhile, Friedlander moved forward connecting faculty members who could meet the COVID-19 testing problem head-on, working with Virginia Tech Legal Counsel Kay Heidbreder and Assistant Vice President for Emergency Management Michael Mulhare in identifying and clearing regulatory hurdles, and working to reach agreements with the Virginia State Health Department, the U.S. Food and Drug Administration, and regional health departments. 

Critically important, Virginia Tech had federal CLIA certification — short for Clinical Laboratory Improvement Amendments — to do complex testing through its Schiffert Student Health Center, which permits the university to perform non-research tests such as the COVID-19 assay using human samples. 

Kanitta Charoensiri, director of Schiffert Health Center, and other center leaders worked to help Friedlander and the teams in Blacksburg and Roanoke apply for testing approval under Schiffert’s license.

Sample testing will enable Virginia Tech to support health providers throughout the region.

“We anticipate a wave of COVID cases, and we need to be ahead of it,” said Sontheimer, a professor of neuroscience in the College of Science. “If you can immediately identify someone as positive for the virus it is a great help, because otherwise that person will infect at least five or 10 more people unnecessarily. We are approaching the point where we should be able to return a conclusive test result of a number of patient samples in a day. Once we get going, our faculty and postdoctoral associates hope to process several hundred samples a day.”

Researchers, such as Finkielstein and Rich Helm, an associate professor of biochemistry in the College of Agriculture and Life Sciences who leads Core Services and the Genomics Sequencing Center, Sontheimer, and others collaborated on the novel assays to identify the virus, using a quantitative real-time polymerase chain reaction (qRT-PCR) protocol to test for RNA of the coronavirus in patient samples.

Meanwhile, neuroscientists Anthony LaMantia and Tom Maynard are working with Friedlander and Sarah Glenn, the associate director of facility development and technical operations, in Roanoke at the Fralin Biomedical Research Institute. 

Lamantia and Maynard relocated their research laboratories to the Fralin Biomedical Research Institute from George Washington University in Washington, D.C., two months ago and readied their new sophisticated platforms for qRT-PCR testing that were recently purchased for developmental brain research to begin using in the newly re-configured COVID testing suites at the research institute.

 The New River Valley Health District has provided samples for validation through the Fralin Life Sciences Institute’s platform in Blacksburg, which are being shared for dual analysis at the Fralin Biomedical Research Institute in Roanoke. Both sites are ready to begin processing samples from the health departments.

"We are appreciative that our colleagues in the College of Science and throughout the university were able to quickly commit themselves to working to address the pandemic that has affected scores of nations and is now in our community,” said Sally C. Morton, dean of the College of Science and former interim director of the Fralin Life Sciences Institute. “Scientists solve problems, and COVID-19 represents one of the most extensive challenges to our national health care system in many decades. The work of Drs. Finkielstein and Sontheimer and others will make a definitive impact in Southwest Virginia and beyond.”

Virginia Tech President Tim Sands said the collaboration to establish two sample testing labs exemplifies Virginia Tech’s commitment to community service as a land-grant research university.

“We have the scientific expertise to address the COVID-19 pandemic throughout the state and the world,” Sands said. “Diagnostic health testing may not be part of our normal academic and research routine, but when lives are at stake, it is Virginia Tech’s role to take action and make a difference wherever we can.”

Paige Bordwine (right), southwest regional epidemiologist for the Virginia Department of Health, walked through labs set up to do COVID-19 testing at the Fralin Biomedical Research Institute in Roanoke and the Fralin Life Sciences Institute in Blacksburg on Tuesday.

Lab inspection
Paige Bordwine (right), southwest regional epidemiologist for the Virginia Department of Health, walked through labs set up to do COVID-19 testing at the Fralin Biomedical Research Institute in Roanoke and the Fralin Life Sciences Institute in Blacksburg on Tuesday.