During the SARS outbreak in 2002, Melissa Miller was a postdoctoral fellow at UNC-Chapel Hill working on a diagnostic test for SARS in case the outbreak turned into a pandemic affecting North Carolina. Thankfully it didn’t. She did the same for MERS and H1N1, also known as swine flu or pandemic flu. She was ready for those outbreaks, too, but North Carolina did not need increased testing capabilities.
In 2019, now a professor in the UNC School of Medicine’s Department of Pathology and Laboratory Medicine, Miller saw a new coronavirus appear in China. When the World Health Organization created a laboratory assay to test people for the infection, Miller sprang into action well before the virus captured the attention of the world. For weeks, as director of the Clinical Microbiology and 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 hard to verify her results and ramp up UNC Health’s capacity to test many samples in one day.
On March 16, the U.S. Food and Drug Administration allowed UNC Health to use Miller’s test, in accordance with FDA guidance for individuals who meet criteria set by the Centers for Disease Control.
The FDA allowance limits the use of Miller’s test for patients at UNC Medical Center, UNC REX Hospital and UNC 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 will allow for more testing capacity at the state health department and LabCorp in North Carolina, and Miller has applied for official FDA approval of her test under the Emergency Use Authorization Act.
On day one, Miller’s lab had the capacity to process 120 samples for COVID-19 testing. By the end of the week, the lab increased its capacity to 300 a day, and UNC Health has 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,” Miller said. “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.”