When COVID-19 overwhelmed the country in March 2020, one of the first crucial actions taken was to quickly rebuild the country’s testing infrastructure.
This was easier said than done, needless to say. Government and industry mobilized to test everywhere, from mass testing sites to retail pharmacies to community centers. Diagnostics manufacturers similarly escalated the production of at-home tests, which became especially popular during the Omicron surge.
But even as the immediate threat from COVID-19 fades, it will be crucial to maintain some form of momentum around testing. At a webinar hosted by the Johns Hopkins Center for Health Security COVID-19 Testing Toolkit and the nonpartisan Capitol Hill Steering Committee on Pandemic Preparedness and Health Security on Wednesday, experts called on policymakers and industry to maintain momentum around testing – both for future COVID surges and other infectious diseases, such as influenza.
“Private/public partnerships have led to widespread production of PCR and rapid tests,” noted Anita Cicero, deputy director at the Johns Hopkins Center for Health Security. “However, it’s been an ongoing challenge to ensure long-term public access to testing, especially during times that demand wanes, like now. This pandemic also illustrates the potential value – and pitfalls – for rapid diagnostic testing for other infectious diseases in the future.”
In recent weeks, Biden administration officials have raised the alarm on this very issue, emphasizing that the federal government is running out of funds to maintain not only testing infrastructure, but also vaccinations and the supply of COVID-19 drugs.
Earlier this month, Congress dropped a $15.6 billion COVID-19 aid package from the government spending bill, leaving much of the federal pandemic plan in jeopardy. In addition, a federal program that provided access to free testing for uninsured Americans ended last week when its money ran out.
“The lack of COVID-related funding in the 2022 omnibus will make it difficult for our response teams to be properly resourced to fight the virus,” Rep. Lori Trahan explained during the webinar. “Waiting to provide funding until we’re in a surge will be too late.”
Trahan laid out the consequences of a potential funding shortfall: an inability to secure sufficient supply of booster shots, to vaccinate or test the uninsured, and to maintain current testing capacity.
The situation isn’t entirely dire. Dr. Tom Inglesby, director of the Hopkins Center for Health Security (who’s currently serving as the White House COVID-19 response team’s senior policy advisor for testing), noted that he sees several ways for the federal government and diagnostics industry to maintain testing momentum.
“The administration has publicly committed to sustaining the U.S. testing infrastructure so we don’t have to go through the constraints many experienced during Omicron,” he noted. “As part of that, we sent a formal request for information to get best ideas from industry on how to sustain and maintain infrastructure – and what can be developed ahead.”
The recently launched Test to Treat initiative aims to boost the number of testing locations across the country – and equip those locations to administer medication to individuals who test positive for COVID-19. The program comes with an education component as well, designed to inform the public about the availability of antiviral drugs.
“It’s a public education effort as well as an effort to reach HCPs, where antivirals have been under-prescribed,” Inglesby said. “[It’s important] to reach healthcare providers with good information, to help them understand these medicines and be more inclined to prescribe them.”
Inglesby also stressed the importance of maintaining state and local testing infrastructure.
“We want local testing programs to continue, at the extent they’re needed, and not scaled down,” he added. “[There will be] support from FEMA for local testing efforts, so we’re hopeful that state and local programs will continue. Now more than ever, people will rely on those programs.”
On the industry side, Susan Van Meter, executive director of AdvaMedDx, said manufacturers should also be wary of decreasing capacity and production during periods when case counts decline.
“When the demand for testing declines, as it did before Delta, we saw a contraction of testing sites and manufacturing capacity,” she noted. “I do have concerns about that. While we have lab capacity now, we should expect to see a contraction there because of lack of demand signals.”
In any event, there are lessons diagnostics manufacturers can learn from the high-scale production of over-the-counter tests during the last year.
“I’m heartened that the U.S. has created the first national stockpile of diagnostic tests,” Van Meter said. “We know there are core technologies and diagnostics that can help us in the future. We need to have a certain stockpile of commonly-used diagnostics, and diagnostic raw materials, to help manufacturers scale up.”
There’s also agreement on policy that would strengthen partnerships between manufacturers and the government to ensure that COVID-19 tests – as well as rapid tests for other infectious diseases – are high-quality.
“We think the Food and Drug Administration did a terrific job once it developed templates for diagnostic test developers, to tell the developers what the agency wanted to see and give them that clarity,” Van Meter said.
By way of example, she pointed to the bipartisan VALID Act, which was reintroduced in Congress last year. The proposed bill would ensure modernized regulation for all diagnostic tests and ensure transparency in test performance for clinicians and patients.
Ultimately, the country needs to figure out how to manage flux in testing demand and create consistency in testing capacity.
“We’ve heard very consistently from U.S. manufacturers that, without more stability, they can’t afford to keep producing tests. It remains clear that this is a problem,” Inglesby said. “While we can add pharmacies and businesses buying tests in the market, the market alone is not going to make the testing availability for surges or to make the market stable. We need to have a strong working partnership between the industry and government.”
If all goes well, the future of rapid testing will remain bright long after COVID-19 recedes as a threat. Expanded testing capacity could be used to diagnose and more quickly treat other conditions – that is, if attention spans don’t wane.
“People have used COVID-19 tests to make decisions on how to isolate, when to send children to school or how to protect vulnerable members of their family,” said Gigi Gronvall, senior scholar at the Hopkins Center for Health Security. “Why stop with COVID? There are a lot of diseases where it would be fantastic to have a test to use at home to stop the spread of disease – if it’s a question of allergies or a more serious disease, if it’s a chicken soup and rest issue, or if you should go to the doctor. This is why diagnostic testing will have such a great future.”