NEW YORK – With President Joseph Biden taking office this week, the lab industry is keen to see what steps his administration will take to boost SARS-CoV-2 testing.
Last week he released details on his $1.9 trillion American Rescue Plan, a legislative package that would include $50 billion to expand SARS-CoV-2 testing and an additional $30 billion investment in the Disaster Relief Fund to help ramp up production of supplies including items like vials, reagents, and protective gear that are essential to collecting and running clinical samples.
The president's plan also calls for doubling the number of drive-through testing sites and investing in new testing technologies, particular at-home and rapid tests.
On Wednesday, Biden signed an executive order establishing the positions of coordinator and deputy coordinator of the COVID-19 response, which according to the order will be responsible for, among other things, "coordinating the Federal Government’s efforts to expand COVID-19 testing and the use of testing as an effective public health response."
On Thursday, the president signed an executive order establishing the COVID-19 Pandemic Testing Board which is tasked with bringing federal resources to expanding testing capacity and improving access to testing. The order also instructs federal agencies to provide free testing for people without insurance and lays out what insurers' obligations are with regard to covering testing.
During a press conference on Thursday presenting his administration's COVID-19 plan, Biden announced that he was signing an executive order to use the Defense Production Act to accelerate the production of supplies, including for testing, and noted that the administration had "already identified suppliers" it is working with.
He also said he was directing the US Department of Education and the US Department of Health and Human Services "with clear guidance and resources to safely reopen schools," and added that expanded SARS-CoV-2 testing would be a key part of this effort.
Mara Aspinall, professor of practice, biomedical diagnostics at Arizona State University, as well as the former president of CEO of Ventana Medical Systems, said that beyond the concrete actions proposed by the Rescue Plan, it is significant in that it appears to recognize the continued need for extensive testing even with the release of vaccines for the virus.
"The first piece [of a testing program] for me is that testing doesn't stop just because we are doing vaccine rollout," said Aspinall, who coauthored Rockefeller Foundation's National COVID-19 National Testing & Contact Tracing Action Plan.
"Number one, the vaccine rollout, even in the best case, will take several more months," she noted. "Number two, not everyone wants to get vaccinated. And number three, even though the vaccines are extraordinarily effective, they aren't 100 percent effective. So, we need to continue to focus on the importance of testing."
Aspinall also highlighted as a key component of the plan the proposed funding to support more frequent testing in schools to help them reopen for in-person instruction.
"We need to use testing to reopen schools as soon as possible," she said, noting that while teachers have been prioritized for vaccines in many states, the timing of vaccination will differ as will uptake of vaccines by teachers. "So we need to continue testing aggressively to be able to continue to have our schools as safe and reliable a place as possible. We need to have teacher and staff and parents feel comfortable, and the only way to do that in the short term is through testing."
Mark Birenbaum, executive director of the National Independent Laboratory Association, said that the proposed funds for testing and protective supplies were welcome. He added, though, that NILA and its member labs would also like to see more efforts to provide transparency around how those supplies are distributed.
"It has really been mysterious how these supplies have been doled out to various laboratories around the country," he said.
Birenbaum said that the federal government directed allotments of supplies and reagents to the states early in the pandemic with the idea being that the states would then distribute them to labs.
"But many times it wasn't clear who had what in their state and how they were giving it out," he said. "Sometimes they gave it to the public health lab and the public health lab had problems in terms of how to distribute it because they didn't know how much testing they were going to be required to perform and how much [of the supplies] they could give out to labs in their state."
Birenbaum added that the country's testing efforts would also benefit from having systems in place to better distribute supplies and samples so that backlogged labs could more efficiently direct specimens and, when needed, supplies, to labs with excess capacity.
He suggested that during the pandemic certain labs had held onto samples even when they could not process them in a timely fashion.
"That contributed to these long turnaround times," he said. "If they were overwhelmed, they should have engaged other labs to help do some of the testing and provided them with some of their supplies and equipment."
Birenbaum did not name any labs specifically, but over the summer Quest Diagnostics struggled with testing backlogs that pushed SARS-CoV-2 test turnaround times to a week or longer throughout much of July. Quest's SARS-CoV-2 turnaround currently averages around two days.
"That's why we need transparency to see exactly how these supplies and equipment are being distributed and to whom," he said. "Not during normal times, but during an emergency, I think you need to know that. We had labs who had the capacity to do 3,000 tests per day that were only doing 300 because they couldn't get some of the supplies and reagents. And if the other labs can't keep up, then in an emergency they need to call upon these labs and say, hey, can you do some of this, and here are some supplies to do it."
He noted that NILA had tried to facilitate these kinds of interactions between its members during the pandemic, but, he said, "I think it needs to be done on a bigger scale. It's something that I think for the future needs to be looked at very carefully."
The American Clinical Laboratory Association declined to comment on the American Rescue Plan when contacted by 360Dx, but last week ACLA President Julie Khani issued a statement that said the plan "takes critical and necessary steps to address core challenges that have persisted since the outset of this pandemic."
"Meeting the evolving needs of patients nationwide requires significant investment in high precision instruments, adequate testing supplies, a highly trained workforce, modernized reporting systems, cutting edge research, and specialized transportation logistics," she added.
In a statement, Scott Becker, CEO of the Association of Public Health Laboratories said the steps proposed by the administration "will substantially boost testing and laboratory capacity, address chronic supply chain issues and improve reporting and collection of data to help further guide the public health response."
Christina Wojewoda, a pathologist and director of microbiology at the University of Vermont Medical Center, said the Biden administration's proposed increase in funding to support efforts by test manufacturers to ramp up their available supplies of reagents, and specifically pipette tips, could have a significant impact.
"It is really reagents and pipette tips that are the limiting factor right now," she said. "And those seem to be things that could be addressed by federal assistance."
Wojewoda said that sampling collection supplies are relatively under control, in part because labs have moved on from hard-to-source supplies.
"I haven't even thought about viral transport media in months," she said. "I don't even know if it exists anymore because everybody switched over to saline because it's cheap and easy to get your hands on."