Crushing the coronavirus: What's Biden's 'clear, unified approach' on testing?
As much of the nation waits on vaccines and variants swirl the globe, experts said President Joe Biden's plan to tackle the pandemic this year will hinge on his ability to bulk up the nation's ability to test for the coronavirus -- a massive undertaking that will require cash and industry cooperation.
Biden has laid out a $50 billion plan that would boost the nation's testing capacity through the increase of rapid antigen tests, testing centers, expand lab test processing, provide uniform guidance for in-school COVID testing and establish a national pandemic testing board.
According to the Rockefeller Foundation, the United States needs 193 million tests monthly for schools and nursing homes "to open safely and in stages" -- a threshold the nation has never reached.
National monthly testing rates reached their highest point since the beginning of the pandemic at 53 million in December, according to the COVID Tracking Project at Johns Hopkins University. Since the start of the year, daily testing rates have remained below 2.5 million.
"Testing has never even gotten close to the numbers that public health experts have laid out to contain the virus," said Alexis Madrigal, a co-founder of the COVID Tracking Project.
Calling for a "clear, unified approach" on testing, Biden underscored an immediate contrast from former President Donald Trump, which largely left state and local governments to coordinate their own strategy on administering coronavirus tests. The Trump administration saw its role as providing the money and supplies to the states, but communities often struggled to keep up with the demand.
Biden's plans have imbued new optimism to those in public health who have for months warned the current U.S. approach isn't working -- though experts say there will be no magic wand.
Coordination of all spheres of government "can't be underemphasized," said Dr. Julie Morita, who was a member of the Biden transition COVID advisory board and executive vice president of the Robert Wood Johnson Foundation.
"And such comprehensive and robust plans are still going to take some time for operationalizing. It's not like a switch can be flipped and we can just go from not a coordinated system to a strong coordinated system, overnight," Morita added.
Experts eye COVID-19 testing as turf where Biden has an opportunity to make his mark.
"It's a way for Biden to totally distinguish his response and it's badly needed," Dr. Michael Mina, assistant professor of epidemiology at Harvard T.H. Chan School of Public Health, told ABC News. "And the aggressive action he could take in rapid-testing innovation really could help define a forward approach."
Ramping up further production will require investment: earlier this month before the transfer of power, Health and Human Services announced $550 million in additional funding allocated to its community-based testing program extended through April 2021. Previously, the Trump administration pushed out more than 150 million Abbott BinaxNOW rapid antigen tests to be used to track the virus in some populations.
As Biden's plan seeks to expand the usage of rapid tests, some debate still lingers among diagnostics experts over whether rapid tests might risk producing false negatives at a higher rate.
But with the vaccine rollout underway, experts said there's no perfect test and widespread surveillance will be an important tool in stopping the spread. Easy access to testing has faced serious issues of inequitable distribution and inconsistent price points over the course of the pandemic.
"You'll miss some, but you'll catch others and you'll catch them early so you can isolate them rapidly and do the contact tracing very promptly as well," said Dr. Wafaa El-Sadr of rapid tests.
"There are situations where in parts of this country there's not the luxury of having PCR testing," El-Sadr, a professor of epidemiology and medicine at Columbia University Mailman School of Public Health, added.
Investments don't begin and end with tests themselves, experts said, more money must also go toward sufficient staffing and supplies, improved technology systems and funding further innovation -- especially if the U.S. is looking to reopen.
Some experts urged Biden to commit a large portion of his $50 billion to rapid antigen tests. Though not as specific as the "gold standard" PCR, they have a higher throughput ability and at lower cost -- essential to reopening efforts in screening a larger share of the population.
Mina told ABC News that he would propose as much as $20 billion be put toward investment in rapid testing.
"The FDA is really lagging behind," he said. "If Biden really wants to make a difference around testing he should immediately use his powers to change the FDA authorization pathway for these rapid tests."
For months, testing companies have been at work to get authorization for rapid, home-based COVID-19 tests. But only a handful of companies have cleared the Food and Drug Administration's manufacturer requirements to get authorization.
A national testing board might have the bandwidth to address such issues, depending on who Biden appoints and their purview. The team will be tasked with expanding testing and fielding further scientific innovation and -- experts hope -- creating a unified message, that public health officials emphasize the need for clarity and consistency which has been absent amid muddled messaging and the politicization of the pandemic in 2020.
"Building back that trust in the federal government is an essential component to this response," Morita said. "Being honest, being clear, being consistent is really important."
Implementing consistent testing protocols within schools nationwide has been another key challenge as some school districts have taken a piecemeal approach to testing because of the lack of clear federal guidelines -- an issue that the newly established pandemic testing board might aim to solve.
The board will also face the complex responsibility of how to "best implement immediate stewardship of resources available now -- while building capacity and understanding where we need to be going and how to get there," Dr. Blythe Adamson, an epidemiologist, economist and former member of the Trump White House coronavirus task force, told ABC News.
Biden has instructed federal agencies to use the Defense Production Act as needed to boost supplies, something the Trump administration said they did more than a dozen times, according to Adm. Brett Giroir, the Trump administration's testing coordinator.
The Korean War-era idea is aimed at pushing manufacturers to ramp up and expedite production -- which now could be used for items including syringes, N95 masks and test ingredients like reagents, pipette tips, kits and nitrocellulose material for rapid antigen tests.
But experts added that manufacturers can't be pushed beyond their ability under the act.
"It's not as though you can grab a company and force a magical, greater supply of their product," Adamson said.
But some elements of that all-hands-on-deck attitude implemented with the DPA, she said, could prove effective, like offering attractive loans to manufacturers to increase their production capacity.
"I've been on the phone with point-of-care testing manufacturers, and they're operating at full speed, but the cost to add a new line to their plant is prohibitive without knowing how long they'd be able to continue using that added manufacturing line," Adamson said. "Hand in hand with advanced purchase commitments, this could help ease that barrier."