STONY BROOK, NY, May 18, 2020 — Stony Brook University now has access to a new highly sensitive clinical test for COVID-19. The new testing protocol, developed in collaboration with scientists at Applied DNA Sciences, received FDA Emergency Use Authorization (EUA) for a unique assay, which detects RNA of SARS Cov-2, the novel coronavirus that causes COVID-19.
The EUA was based on clinical studies performed in the Molecular Pathology Laboratory of Stony Brook University Hospital (SBUH), directed by Dr. Silvia Spitzer and supported by Pathology resident, Dr. Karen Bai, Medical Scientist Training Program (MSTP) student, John Yuen as well as several other graduate and MSTP student volunteers.
According to Dr. Kenneth Shroyer, Chair of the Department of Pathology, the efforts put forth by the team provided the FDA with the necessary evidence demonstrating the new RNA assay is highly sensitive and specific and thus, could provide another tool that could be deployed to perform COVID-19 testing for patients at Stony Brook University Hospital.
“This collaboration to enable high throughput and accurate COVID-19 testing addresses the needs of Stony Brook Medicine, our local communities, and New York State,” said Dr. Kenneth Kaushansky, Senior Vice President for Health Sciences and Dean of the Renaissance School of Medicine. “It firmly represents an outstanding example of the academic-industrial collaborations that are enhancing our ability to provide the best possible care for our patients.”