WASHINGTON -- Today, the U.S. Department of Health and Human Services (HHS) agreed to implement a streamlined process by which the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) will collaborate to conduct reviews of Emergency Use Authorizations (EUA) submitted by laboratories working to develop and administer tests for the coronavirus. This will allow laboratories, including those at academic institutions, to continue rapid development of safe, accurate coronavirus tests. The HHS decision follows calls by U.S. Senator Amy Klobuchar (D-MN) for the agencies to take action to expand our testing capacity with tests produced at academic laboratories - such as the University of Minnesota’s Genomic Center, which is developing a process to produce approximately 60,000 tests per day.
“Since the start of this pandemic, I have been pushing for increased testing capacity so we can save lives. Lab-based testing efforts that can offer rapid, accurate, and inexpensive testing, like the one at the University of Minnesota, are essential to helping us control the spread of the coronavirus,” Klobuchar said. “That is why I am relieved that the Department of Health and Human Services agreed to streamline the review process for laboratories working to develop and administer these tests. With cases spiking across the country, these efforts are more critical than ever. ”