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Amid Coronavirus Outbreak, FDA and Industry Seek Roadmap for Emergency Diagnostics 

Diagnostics & Healthcare News February 3, 2020

Just as some manufacturers hasten to make tests available for the novel Wuhan coronavirus, FDA will convene with industry representatives Monday in hopes of developing a better “roadmap” for how diagnostics are evaluated during and potentially after emergencies.

Doctors Walking Down a Hall

The workshop was planned months before the Chinese outbreak to address the relatively few diagnostics that make the transition from emergency use authorization to full marketing status.

“Often what happens is that you get those diagnostic tests out in the market, use them during an emergency, and then when the emergency is waning, they are not submitted for approval to FDA,” said Danelle Miller, Roche Diagnostics’ vice president of global regulatory policy and intelligence.

Regulators and manufacturers alike have recent lessons to draw from, given that HHS issued declarations authorizing emergency use of diagnostics for Ebola virus in 2014 and Zika virus in 2016. HHS issued a declaration for the coronavirus Friday, following the World Health Organization officially labeling the outbreak a public health emergency, the sixth such declaration since the designation was created in 2005.

While EUA serves a clear purpose in emergency cases with no available diagnostic alternatives, a transition to full marketing status reflects additional data to back safety and effectiveness, giving healthcare providers further assurance, FDA said.

Once an emergency is contained, the “population-based medical value assessment and the business case for commercializing a test may vanish as the epidemic resolves and as test use diminishes.”

See Full Press Release: Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics | MedTech Dive

Written by: Maria Rachal

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