By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence
The U.S. Department of Health and Human Services Secretary issued a notice declaring the enterovirus D68 (EV-D68) poses a “significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad.” Thus, based on that determination, the Secretary also announced that these circumstances justify authorization of emergency use of new in vitro diagnostics to detect EV-D68.
This is the first step toward the FDA authorizing emergency use of an unapproved diagnostic test for detection of the virus. The notice indicates that the Centers for Disease Control and prevention (CDC) requested that emergency use of new in vitro diagnostics be authorized for detecting EV-D68 “to allow the Department to take preparedness measures based on information currently available about the EV-D68.”
The CDC explains that EV-D68 is a non-polio enterovirus causing respiratory symptoms and is transmitted between individuals through an infected person’s coughing or sneezing or when individuals touch surfaces previously touched by others with the virus. It believes infants, children, and teenagers are most at risk of infection. While the CDC reports that enteroviruses appear every year, “during 2014 the number of people reported with confirmed EV-D68 infection was much greater than that reported in previous years.” Specifically, CDC indicates that 1,153 cases of EV-D68 were confirmed between mid-August 2014 and January 15, 2015, in 49 states and the District of Columbia. The CDC also estimates millions of other patients may have been infected with EV-D68 but had mild cases and didn’t get tested. Lab tests can detect the presence of enterovirus but the CDC indicates testing used by hospitals and physicians can’t indicate which type of enterovirus (such as EV-D68) is involved.