Trump emergency plan boosts diagnostic testing rollout

By Brian Casey, LabPulse.com editorial director

A rapid scale-up of diagnostic testing for the novel coronavirus was the focus of a declaration of emergency by President Donald Trump in a March 13 press conference. The plan calls for sharply boosting the production of coronavirus test kits while also making tests available at a network of drive-through sites.

In an address at the White House Rose Garden, Trump announced a series of sweeping measures designed to eliminate government regulations that may have been hindering the federal response to the coronavirus outbreak. Most of Trump's address was devoted to the administration's plans for making diagnostic testing more available across the country -- an issue that has become a flash point for criticism of the administration's response to the virus.

In his emergency declaration, Trump said that previous government regulation included "very old and obsolete" rules. The new declaration would enable the U.S. Department of Health and Human Services (HHS) to waive rules that may have impeded hospitals and healthcare providers from responding adequately to the coronavirus outbreak. The declaration would also make available $50 billion in federal funding to fight the outbreak.

But Trump reserved the lion's share of his speech to explain what the administration is doing to make diagnostic test kits more available to test for SARS-CoV-2. Healthcare providers and clinical labs in the field have complained that they have not had enough coronavirus tests available to meet demand, and some have claimed that testing criteria have been too restrictive.

The new plan relies on a combination of making more testing capacity available and at the same time making it easier for Americans to get tested, such as with drive-through testing sites. The administration is also working with Google to set up a website that will enable Americans to determine on their own whether they should seek out testing.

With respect to testing capacity, Trump explained the work the administration has been doing with diagnostics manufacturers such as Roche and Thermo Fisher that builds on a meeting between diagnostics vendors and the government last week.

Roche developed a high-throughput test for the coronavirus, cobas SARS-CoV-2, that received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) within 24 hours of submission of an application. The test's high-volume capacity should be a step forward in meeting demand for coronavirus testing, Trump said.

Trump noted that a second test, by Thermo Fisher Scientific, is following quickly behind the Roche assay, and he hopes that the FDA will also be able to approve this test within 24 hours of receiving an application. Taken together, the two tests should expand coronavirus testing capacity by 1.4 million tests, Trump said.

In remarks given after Trump's speech, Dr. Deborah Birx, who was named White House coronavirus response coordinator last month, contrasted the administration's response to the coronavirus outbreak with the slower response to the HIV outbreak in the 1980s. The first AIDS cases appeared in 1981, but a test wasn't available until 1985, she said.

Birx also noted that much of the administration's work on coronavirus response has been happening out of the public spotlight.

"I understand that a lot of this behind-the-scenes action over the last couple of weeks was invisible to the press and American people," Birx said. "But this intense effort has not only resulted in innovative solutions, but an automated high-throughput system bringing the availability of quality coronaviral testing to the American people at unprecedented speed."

The second element of the plan to expand coronavirus testing is to make the kits more available to the public. To that end, the administration plans to work with retailers such as Walmart, CVS, Walgreens, and Target to aggressively expand the number of testing sites. An executive with Walmart, for example, pledged to devote space in the stores' parking lots to drive-through testing sites.

The final point in the plan is to help Americans decide whether they should get tested. Trump noted that the administration did not want everyone to get tested -- only those who met certain criteria. To that end, the administration has been working with Google to set up a website that will allow Americans to find out if they need a test by answering a series of questions.

If individuals confirm that they have symptoms of COVID-19, they will be directed to a drive-through testing facility. By running samples through high-throughput systems like the Roche and Thermo Fisher devices, results will be available in 24 to 36 hours, Birx said.

In his own remarks at the press conference, Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said the new plan would help remove constraints that have hindered the government's response to the outbreak.

"We still have a long way to go, there will be many more cases, but we will take care of that," Fauci said. "Ultimately ... this will end, but what's going on here today is going to help it to end sooner than it would have."


Copyright © 2020 LabPulse.com
 

To read this and get access to all of the exclusive content on LabPulse.com, create a free account or sign in now.

Member Sign In:
MemberID or email address:  
Do you have a LabPulse.com password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?