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11th February 2020  Editorial by: Paul Carton

HHS Opens up Funding Agency for 2019-nCoV Diagnostic Kits

There are now 13 people diagnosed with 2019-nCoV in the United States (CDC, 02/10/2019). The US Department of Health and Human Services (HHS) has declared it a public health emergency and has opened up funding for diagnostic manufacturers to apply for to develop their 2019-nCoV diagnostic kits.

The diagnostic technology on what the application is based on must already be cleared by the FDA along with a plan that can meet the FDA requirements for Emergency Use Authorisation (EUA) within 12 weeks of receiving the award. 

The Easy Broad Agency Announcement (EZ-BAA) award has been modified by BARDA DRIVe, the research arm of the HHS that works with commercial partners, to allow a grant to be given to diagnostic products in response to the 2019-nCoV outbreak.

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Date Published: 11th February 2020

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