NEW YORK – As the US tries to take hold of the growing coronavirus outbreak within its borders, the Trump administration on March 13 hightlighted the role of the private sector as its to increase SARS-CoV-2 testing capacity.
During a press conference to declare a national emergency over COVID-19, the disease caused by the SARS-CoV-2 coronavirus, Trump surrounded himself with executives from commercial test developers, clinical labs, pharmacy retailers, and others to announce a "new partnership with private sector to vastly increase and accelerate our capacity to test for the coronavirus. We want to make sure that those who need a test can get a test very safely, quickly, and conveniently."
What form the partnership is taking is unclear, and details about it were not disclosed, but as the administration tries to catch up with a growing demand for coronavirus testing, commercial test makers and labs will need to play a significant role.
As of Saturday, the coronavirus had infected about 2,200 people and killed about 48 in the US. Some say, however, that the numbers may actually be considerably higher as a limited availability of testing may mask the true figures. According to some estimates, only about 19,000 SARS-CoV-2 tests have been performed in the US so far, and the administration has been roundly criticized for the way it has bungled testing for the coronavirus.
In announcing the national emergency, the administration is taking a number of steps to manage the outbreak, including waiving laws to make telehealth more accessible and allowing doctors to practice across state lines to provide their services where they are most needed. Rules for when a patient in a hospital is eligible to be admitted to a nursing home may also be waived.
In the testing arena, according to Trump, a first outcome of a new relationship between the private sector and the federal government in coronavirus testing was the expedited Emergency Use Authorization granted to Roche on Friday by the US Food and Drug Administration for the Cobas SARS-CoV-2 test.
"We did this within hours after receiving the application from Roche – a process that would normally take weeks," Trump said. "We therefore expect up to half a million additional tests will be available early next week."
The Trump administration and the commercial sector may have started working together as early as a week ago. According to Quest Chairman, President, and CEO Steve Rusckowski, his firm and others were called to come together last week under the leadership of Vice President Mike Pence. "And we took advantage of that opportunity to work with the FDA, to work with the [US Centers for Disease Control and Prevention]. And we are up and running with tests in a number of our facilities," he said during the press conference.
Commercial players, however, have been developing tests and reagents for detecting SARS-CoV-2 and diagnosing COVID-19 for weeks now. When the FDA issued its first EUA for a coronavirus test in early February, for a CDC test, it also said that it was working with other diagnostic developers to accelerate test development and EUA requests.
In late February, the FDA also relaxed its rules to allow high-complexity CLIA-certified labs to immediately perform tests they developed and validated for SARS-CoV-2 while they pursued Emergency Use Authorization. Since then, a number of commercial labs, including Quest Diagnostics, Laboratory Corporation of America, and Opko Health's BioReference Laboratories have launched their coronavirus tests.
On Friday, the CEOs of Quest and LabCorp reiterated their commitment to increase testing capacity in the US.
Rusckowski said that his firm would be bringing in Roche's EUA test during the weekend, as would LabCorp, "so the capacity available to the American public to support this action with consumers will be considerably increased in the next few weeks."
LabCorp President and CEO Adam Schechter added that his firm is "working with academic medical centers, with our colleagues at Quest, with other hospitals and other laboratories to ensure that we do everything we can to increase the testing as we move forward."
Deborah Birx, coronavirus response coordinator for the White House, noted during the press conference that expanded testing at Quest and LabCorp has found that the proportion of coronavirus tests coming back positive for COVID-19 is about 1 to 2 percent. By comparison, in South Korea, which has more than 8,000 cases and 72 deaths, the positivity rate is between 3 and 4 percent, she said.
The White House also is calling on test makers to step up, and subsequent to the press conference, Thermo Fisher Scientific announced it was issued EUA by the FDA for its TaqPath COVID-19 Combo Kit for detecting the coronavirus. The test can now be used by high-complexity CLIA labs for patient testing.
Becton Dickinson President and CEO Tom Polen noted at the press conference that the company will be increasing its manufacturing capacity of collection devices and testing equipment. In a statement, he added that BD would work "around the clock internally and with external partners to increase the coronavirus diagnostic capacity in the US."
In the coming week, the company will submit an EUA request to the FDA for a coronavirus test for use on the BD Max molecular diagnostic platform. The firm is also looking into developing a point-of-care test for SARS-CoV-2 for use on the BD Veritor system.
During his remarks, Trump also said that tech giant Google was in the process of developing a website to help patients assess whether they need to be tested for the coronavirus and to help them find a nearby location for testing, if necessary. He further said that 1,700 Google engineers are currently working on the endeavor.
As it turns out, it's not Google but its sister company Verily Life Sciences that is working on such a website. In a statement posted on Twitter, Verily provided little information about the effort.
"We are developing a tool to help triage individuals with COVID-19 testing," the firm said. "Verily is in the early stages of development and planning to roll testing out in the Bay Area, with the hope of expanding more broadly over time. We appreciate the support of government officials and industry partners and thank the Google engineers who have volunteered to be part of this effort."
Lastly, retailers will also play a part to increase SARS-CoV-2 testing capacity. Walmart, CVS, Walgreens, and Target, all of whom participated in Friday's press conference, said that they will dedicate spaces, probably in parking lots, in some stores to provide coronavirus testing.