While Germany, South Korea, and Taiwan implemented aggressive testing strategies and infrastructure during the early spread of SARS-CoV-2, the United States failed to develop and distribute reliable diagnostic tests when the pandemic initially hit the country, according to a new report.
This failure cost thousands their lives.
In a report released this week, “Diagnostics for Biodefense: Flying Blind with No Plan to Land,” the Bipartisan Commission on Biodefense describes the ways in which these missteps by the U.S. government lead to a public health breakdown. The report also outlines the diagnostics steps that should be taken to combat further spread of the virus.
“Diagnostics touch every facet of the response to a biological event,” said Commission Co-Chair, former U.S. Sen. Joe Lieberman, in a written statement. “Failing to establish a robust testing regimen early in an outbreak has cascading effects that cripple the nation’s ability to effectively respond and contain spread. The Administration and Congress should not wait until COVID-19 recedes to take up these important recommendations. Instead, they should establish diagnostic testing capacity and support development of new tests to address COVID-19 now and for the infectious disease pandemics or bioterrorist attacks to come.”
To organize greater diagnostic testing capacity, the Commission recommends the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 be amended to direct the Secretary of Health and Human Services, along with the Secretary of Defense, to establish a task force to create a national plan for COVID-19 testing. This task force would be charged with establishing innovative diagnostic solutions and dramatically scaling up testing across the country.
The report calls on Congress to require this task force to develop and implement a national plan to:
- Organize and optimize the development and deployment of COVID-19 testing throughout the United States;
- Identify and determine how to overcome the complex logistical and administrative impediments posed by government bureaucracies, commercial self-interest, and inefficient local acquisition mechanisms;
- Overcome these obstacles;
- Identify and determine how to overcome supply shortages that prevent testing;
- Actively seek out alternative diagnostic methods that would require different supplies (so as not to put the same strain on the supply chain currently seen); and
- Evaluate strategies that could alleviate pressure on the supply chain, such as pool testing (which must be complemented by a low positivity rate and robust test and trace capabilities to provide value).
One of the goals would be to establish centralized laboratory-based diagnostic tests, as well as develop cutting-edge point-of-care and point-of-need diagnostics that someone with limited training can use. These tests should produce results in less than 30 minutes, according to the report.
Government bureaucracy hindered testing early in the pandemic. Ideally, Emergency Use Authorization (EUA) is supposed to fast-track innovation, but when the U.S. Secretary of Health and Human Services, Alex Azar, declared a public health emergency in January and allowed the Food and Drug Administration (FDA) to provide EUA for some diagnostic tests, it had unintended consequences. Clinical laboratories can develop tests without FDA approval, however, those that went through the EUA process found it “lengthy and cumbersome” and none successfully navigated it “nearly a month after the public health emergency declaration,” according to the report. While the FDA intended for this process to protect against the use of faulty tests, these inadequacies also meant tests developed by other countries could not be used in the United States.
“Because of COVID-19, we saw some additional investment in diagnostics, but not anywhere close to the degree required to keep the nation safe from biological threats,” said Commission Co-Chair and former Secretary of Homeland Security Secretary Tom Ridge. “Despite top U.S. health officials recognizing that existing diagnostic technology cannot cope with COVID-19 and that the obvious need for new, innovative diagnostic technologies, the federal government continues to more highly prioritize and invest in vaccines and therapeutics. We must seize upon the opportunity provided by COVID-19 to ensure that our nation possesses or can develop the diagnostic tests it needs when it needs them.”
Testing is critical to helping decision-makers take steps to save lives, say the report’s authors. Take New York as an example. On March 1, the first confirmed case of COVID-19 appeared in that state. If health officials had had better diagnostic testing, they may have discovered that already 10,000 infections were present during that time. They could have closed restaurants, bars, and schools sooner and issued a stay-at-home order earlier. It may have prevented 54,000 deaths.