CAROLINA ON OUR MIND HAP P ENIN G S AT U N C

U N C Re se archers Lea d t he C h a rg e Ag a inst the Co ro nav irus O ut b re a k Melissa Miller and her team sprung into action early to develop a test for COVID-19. By Mark Derewi cz

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uring the SARS outbreak in 2002, Melissa Miller was a postdoctoral fellow at UNC working on a diagnostic test in case the outbreak turned into a pandemic that would affect North Carolina. Thankfully, it didn’t. She did the same for MERS and H1N1, also known as swine flu or pandemic flu. North Carolina did not end up needing increased testing capabilities, but she was ready for those outbreaks, too. In 2019, Melissa, now a professor in the UNC School of Medicine’s Department of Pathology and Laboratory Medicine, saw a new coronavirus appear in China. When the World Health Organization created a laboratory assay to test people for the infection, Melissa reacted well before the virus captured the attention of the world. For weeks, as director of the Clinical Molecular Microbiology Labs at the UNC Medical Center, she led a team of technicians to develop a test for coronavirus disease 2019. She focused on identifying the new virus’ unique genetic sequence, and when she succeeded, she worked to verify her results and ramp up UNC Health’s capacity to test many samples in one day. On March 16, the Food and Drug Administration allowed UNC Health to use Melissa’s test, in accordance with its guidance for individuals who meet Centers for Disease Control and Prevention criteria. The FDA allowance limits the use of Melissa’s test for patients at UNC Medical Center, UNC REX Healthcare in Raleigh and UNC 16

Health affiliate hospitals across North Carolina, as well as a select number of UNC Health clinic locations. Use of this test by UNC Health entities allows for increased testing capacity at the state health department and LabCorp in North Carolina, and Melissa has applied for official FDA approval of her test under the Emergency Use Authorization authority. On day one, Melissa’s lab had the capacity to process 120 samples for COVID-19 testing. By the end of the week, the lab was up to 300 a day, and UNC Health had purchased new equipment to boost testing capacity to 500 samples a day. “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,” Melissa says. “We have developed a highquality test, we have the infrastructure to roll it out, and [we] are ready to help the people of our state.”