The FDA has granted an emergency authorization to the Centers for Disease Control and Prevention’s (CDC's) novel coronavirus diagnostic, allowing it to be used at qualified and designated laboratories across the country.
Until now, the test—a real-time RT-PCR panel that searches for traces of viral RNA in nasal or oral swabs—could only be used to evaluate samples shipped to the CDC’s own labs, slowing the agency’s turnaround time in responding to the spread of the disease.
FDA Commissioner Stephen Hahn described the move as a “critical step forward in protecting the public health.” Since the new virus was first identified in Wuhan, China, last December, the World Health Organization has confirmed more than 24,500 cases of the disease in 25 countries with at least 425 deaths, including 11 cases in the U.S.
Though federal health officials say they believe the chances of the disease spreading within the country are low, Department of Health and Human Services Secretary Alex Azar declared a public health emergency Jan. 31 in response to the threat.
Currently, there are no other FDA-cleared or commercially available diagnostics for the virus, dubbed 2019-nCoV.
The agency said it is working with coronavirus test developers to accelerate their development programs by sharing scientific reference materials and providing companies with templates to request their own emergency use authorizations from the federal government. Additionally, those developing therapeutics have been invited to join the FDA’s pre-IND program.
Emergency use authorizations have been granted in the past to in vitro diagnostic kits for other biological threats, such as during outbreaks of the Zika and Ebola viruses and for certain strains of influenza.
Separately, the FDA has notified blood donation centers that they may encourage potential donors to defer giving blood if they have traveled to areas affected by the outbreak or if they suspect a potential infection.
However, the agency said the potential for 2019-nCoV transmission through blood, as with respiratory viruses in general, is considered low and should be caught by routine screening methods—such as donors being in good health and having a normal body temperature on the day of donation.