WASHINGTON — Millions more coronavirus tests are needed to curb the spread of the virus and guide decisions around safely reopening businesses and schools, Sen. Lamar Alexander (R-Tenn.), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, said during a hearing on Thursday.
“There is no safe path forward to combat the novel coronavirus without adequate testing,” Alexander said.
National Institutes of Health Director Francis Collins, MD, PhD, a witness at the hearing, described a new initiative that aims to answer exactly this problem.
The Rapid Acceleration of Diagnostics or RADx, launched last week, will fast-track new inexpensive, reliable, and easy-to-access diagnostic tests, Collins said.
Most of the tests currently available are polymerase chain reaction (PCR) tests that take time to run, require certain trained personnel, and special equipment — a thermal cycling machine — typically only available in labs.
“We need tests that don’t require hours or days to determine results,” he said. Abbott’s desktop PCR system that delivers results in 15 minutes, initially considered a “game changer” for COVID-19 testing, has not lived up to the hype, in part because of relatively high false-negative rates that have made it seem unreliable. Its FDA authorization also requires that it be used only in labs qualified for moderate or high complexity testing, putting it out of reach for most providers.
The RADx program, with a $1.5 billion investment from federal stimulus funding, aims to develop point-of-care tests that are reliable, and sensitive enough to flag even asymptomatic individuals. These tests should also be user-friendly — ideally using saliva samples or blood as well as nasal swabs — and their results should be transmissible by mobile phone, noted Collins.
During questioning, Collins also revealed that he anticipates that a number of the protocol concepts will involve CRISPR, the gene-editing tool, which he described as a “powerful way” to find a “little bit of virus.”
Most importantly, Collins stressed, the tests should be accessible to everyone who needs them.
A review board of experts in clinical, technical, business, regulatory, and manufacturing will evaluate proposals for new tests. Promising submissions will enter into Phase I, where they will be given modest funding as well as technical and clinical support from the reviewers. Well-developed technologies can leapfrog other submissions and begin in Phase II of the program, receiving help to scale the tests for validation, regulatory assessment, and ultimately production and distribution.
While the main focus of the initiative is the development of point-of-care tests, lab-based approaches, especially those that increase the throughput of lab-based tests, would also be considered “as intermediate solutions,” Collins said.
The agency, however, will actively pursue one type of testing, viral antigen testing, which doesn’t require PCR and allows for immediate detection of the virus. Over time, such a test could be taken at home.
The primary goal is to make millions of these tests available by the end of summer, in time for flu season, he said. This is a “stretch goal” and one that many experts say is impossible, but Collins said he remains hopeful.
As of noon on Wednesday, 1,087 applications for the program had been started, 79 were completed, and 20 proposals were ready to be evaluated.
Senators asked for reassurance that the tests would be of good quality and not simply inexpensive, and asked Collins to ensure that the tests would be available in rural areas, even those that haven’t been hard-hit yet.
Collins stressed that these tests would be of high quality and would be made widely available.
He also noted that one part of the initiative would home in on under-served populations that to date have struggled to access tests. Pilot programs would be put in place in certain communities, with the specific aim of “equalizing access” to diagnostics and treatment.
Sen. Mitt Romney (R-Utah) asked whether this kind of testing was really needed if reports that 50-90% of people with the virus are asymptomatic.
“[S]hould we let the virus run its course through the population and not try and test every person?” he asked.
Collins responded that while it’s “extremely unusual” to have a virus in which perhaps 60% of people are asymptomatic, there are still 74,500 people who have died.
“The only way we’re really going to put a stop to that is to know who the people are who are infected … get them quarantined [and] follow their contacts … it’s just good solid shoe-leather public health.”
In between asking logistical questions about the initiative, Democratic senators chastised the Trump administration, blaming the over one million cases of COVID-19 to date on a lack of leadership and a failure to plan.
“It shouldn’t be lost on us how far behind we are on testing,” said Sen. Chris Murphy (D-Conn.), adding that “it’s not an accident.”
He cited a comment from President Trump just the day before who said “by doing all this testing we make ourselves look bad.”
Sen. Patty Murray (D-Wash.) who helped pass into legislation a bill requiring the administration to establish a national strategic plan to increase testing by May 24, reminded the witnesses of the need for numbers and timelines.
“No matter how innovative our tests are, we cannot reopen our country safely until they are fast, free, and everywhere,” and she emphasized the need for the federal government to “do its part.”