Carla Finkielstein (left), an associate professor of biological sciences, is coordinating COVID-19 test development on the Blacksburg campus with Rich Helm, an associate professor of biochemistry who leads Core Services and the Genomics Sequencing Center
Virginia Tech scientists have developed a new COVID-19 test and have 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 Virginia Tech Carilion 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.
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 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.”
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.”
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.”
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.”
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.”
