Georgia-Battelle Principal Research Scientist Roy Johnson was part of a team that was awarded the Association of Public Health Laboratories (APHL) Presidential Award for outstanding contributions to support public health laboratories during the influenza H1N1 pandemic response. The award was presented to the Influenza Division of the Centers for Disease Control and Prevention (CDC).
Johnson was one of four people from the Influenza Division team singled out by the APHL and the only Battelle employee named, though he represents a team of Battelle staff who worked on the project. Johnson works in the Influenza Division at CDC-Atlanta where he is a subject matter expert (SME) in the FDA’s processes for development, manufacture, and clearance of in vitro diagnostics (IVDs).
Johnson played a critical role in CDC’s ability to respond to the H1N1 pandemic and was in constant communication with high- ranking health officials both within and outside of CDC during the H1N1 pandemic. His expertise in the regulatory process became evident during activities that led to the clearance of IVDs under Emergency Use Authorization (EUA). Johnson was mostly responsible for the determination of a new regulatory mechanism for the clearance of fielded Research Use Only (RUO) devices for use with IVDs.
Through Johnson’s leadership, a flu diagnostic test was cleared, manufactured and delivered to public health laboratories in the United States and internationally in only eight days. Johnson and his team’s efforts proved to be a major milestone for CDC in improving their ability to respond in a timely manner to this public health crisis.
Johnson’s regulatory expertise facilitated both the clearance of the seasonal flu assay and the EUA for the H1N1 assay and provided teleconference training to help all labs implement the test and coordinate all the instrument upgrades.
In a letter from the APHL, the team was acknowledged for its dedication. "Those of us in the know truly appreciate the amazing efforts of the entire influenza team to provide reliable and rapid diagnostics to the nation in lightning speed, and the continued efforts to support and sustain the capacity that has been built."