U.S. Embassy & Consulate
in the Kingdom of Denmark

The Trump Administration is taking action to speed up coronavirus testing and increase accessibility across the country.

The FDA is working to help significantly speed up testing and expand accessibility for Americans.

• The FDA issued emergency approval for a new commercial coronavirus test by Roche that will help greatly expand testing nationwide.
  • FDA: “The FDA authorized the Roche cobas SARS-CoV-2 Test, the third Emergency Use Authorization (EUA) granted for a diagnostic test during the COVID-19 outbreak.”
  • FDA: “Laboratories can immediately run tests on Roche’s high-volume platform, which will greatly increase national testing capacity.”
• Emergency approval is expected to come very shortly for another commercial test that will expand testing capacity even more.
• As public health experts have noted, this emergency approval will help significantly accelerate testing.
  • NIAID DIRECTOR ANTHONY FAUCI: “Within a week we’re going to start seeing a real acceleration of testing. I think we are going to see a much different situation than we saw just a few weeks ago.”
  • FORMER FDA COMMISSIONER SCOTT GOTTLIEB: “Very significant approval. Will substantially increase patient testing capacity by end of next week by tens of thousands a day across all labs, commercial and academic.”
• This builds on the Administration’s efforts to cut red tape and expand access to testing.
  • FAUCI: “If a person comes in right now or at least in the next few days to a week and has a symptom that is suggestive of coronavirus, back a week or two or three ago, there were restrictions on that. Those restrictions have been lifted by the FDA.”
  • FAUCI: “One of the restrictions were you had to have proven contact with someone who either has coronavirus or suspected of coronavirus. That’s off the board now.”

The Administration is working with the private sector to help set up drive through testing sites in critical areas impacted by the coronavirus. 

• PRESIDENT TRUMP: “We’ve been in discussions with pharmacies and retailers to make drive-through tests available in the critical locations identified by public health professionals.”

The Department of Health and Human Services is helping accelerate the development of rapid diagnostic testing.

• HHS has announced it is providing funding for the accelerated development of two rapid diagnostic tests for the coronavirus.
  • HHS: “Two diagnostic tests that may detect severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in approximately one hour will receive advanced development support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.”

The FDA is providing new flexibility to the New York State Department of Health to authorize expanded testing at private and public laboratories.

• FDA: “[T]he agency issued enforcement discretion and is not objecting to the New York State Department of Health (NYSDOH) authorizing certain laboratories in New York to begin patient testing after validating their tests and notifying the NYSDOH.”
• FDA: “The FDA is granting this flexibility to NYSDOH based on the urgent public health need for additional testing capacity.” 
• Governor Cuomo thanked President Trump and the Vice President for helping New York dramatically expand its testing capability.
  • GOV. CUOMO: “I spoke with the Vice President today and I spoke with the President, and they are authorizing New York State to do the testing, and allowing our labs to do the tests, and allowing the state health department to set up the protocol. That will increase dramatically our testing capacity. I want to thank the president and the vice President for their receptivity to the idea, and I want to thank them for their quick turnaround.”
  • GOV. CUOMO: “The labs will be coming on, we think next week we’ll go up to a capacity of about 6,000 tests per day which would be a dramatic increase for us. To date, we’ve done about 3,000 tests. So that is a very, very big difference.”

The Administration has designated Admiral Brett Giroir to take point in coordinating coronavirus testing efforts.

• Dr. Giroir’s leadership and experience will help ensure strong coordination between the CDC, FDA, state and local public health authorities, and private labs.  
• As Secretary Azar stated: “A key priority is to ensure that patients, doctors, and hospitals can access tests seamlessly and with maximum ease, and Dr. Giroir will lead efforts to execute on that goal.”
• Dr. Giroir serves as Assistant Secretary for Health at HHS and has an extensive medical background.