WASHINGTON, D.C. – As UNC Health faced bureaucratic delays from the FDA to launch UNC Health’s new breakthrough coronavirus (COVID-19) diagnostic test, Senator Thom Tillis (R-NC) worked behind the scenes to urge the FDA to expedite the process so UNC Health could begin coronavirus testing as soon as possible.
Today, UNC Health announced that UNC Medical Center and UNC School of Medicine in Chapel Hill have developed a COVID-19 diagnostic test based on the World Health Organization (WHO) assay. It is now in use to conduct coronavirus testing for UNC Health patients in accordance with FDA guidance for individuals who meet criteria set by the CDC. The use of UNC Health’s test by entities across the state will increase testing capacity at the state health department and LabCorp in North Carolina.
“I applaud UNC Health for once again showing that North Carolina is the tip of the spear when it comes to biomedical innovation, developing one of the fastest coronavirus test protocols while conserving reagent, which remains in critically short supply,” said Senator Thom Tillis. “This is a major accomplishment for UNC, Dr. Miller, and the team, and a breakthrough that will help address the testing capability shortage in North Carolina. I applaud the FDA for considering our requests to expedite allowance to make innovative diagnostics available to the public without further delay.”
“The ability to conduct in-house testing is a crucial step in our response to COVID-19. Our ability to test patients and receive results in a matter of hours will help us to better understand the spread of the virus in our state and, most importantly, allow us to quickly move to treat positive patients and provide relief to patients who test negative,” said Dr. Wesley Burks, UNC Health CEO and Medical School Dean. “I would like to thank our US delegation who supported our efforts, especially Senator Tillis for his leadership on this critical issue and thank the many members of our UNC Health team who have worked tirelessly to develop this test and plan for its successful deployment.”
“Quickly creating and validating tests for emerging pathogens has always been part of my passion and commitment, ever since I was a fellow here during SARS,” said Melissa Miller, PhD, director of the Clinical Microbiology and Molecular Microbiology Labs at the UNC Medical Center. “We have developed a high-quality test, we have the infrastructure to roll it out, and are ready to help the people of our state.”
For more information, North Carolinians can visit the UNC Health COVID-19 Resources website: