NIH Ramps Up Point-of-Care COVID-19 Testing: Progress Report

Ken Terry

July 23, 2020

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The National Institutes of Health (NIH) on Wednesday delivered a progress report on its crash program to facilitate the development and implementation of new point-of-care COVID-19 tests by the end of this year.

NIH aims to facilitate COVID-19 testing that will cover 2% of the US population (6 million people) each day by December, NIH Director Francis Collins, MD, and colleagues write in an article published online July 22 in the New England Journal of Medicine. That testing rate would be eight to 10 times higher than the current daily rate.

Using $1.5 billion appropriated by Congress in April, the agency's Rapid Acceleration of Diagnostics (RADx) program has been working with private companies to "support the development, production scale-up, and deployment of accurate, rapid tests across the country," the authors explain. The goal is to greatly increase the amount of testing by early fall, when some schools are expected to reopen and when influenza season begins.

Currently, US testing capacity fluctuates between 520,000 and 823,000 tests per day. Some experts have estimated the United States currently needs 20 million tests per day to help control the pandemic, authors write.

In an unrelated announcement Wednesday, the Advanced Medical Technology Association (AdvaMed) unveiled a national COVID-19 diagnostic supply registry to help state and federal governments respond to the pandemic. The registry will compile information from diagnostic test manufacturers plus publicly available data on the number of tests performed.

AdvaMed estimates that test shipments now top 800,000 daily. Scott Whitaker, president and CEO of AdvaMed, declared in a news release, "Our industry stepped up and, practically overnight, maximized production of the vital medical technologies and testing we need."

"Innovation Funnel"

The NIH has more ambitious goals. According to its report, the mission of RADx is to expand the use of current COVID-19 tests and to develop new assays that might provide reliable results faster. That's a key issue at a time when it can take up to a week or more to provide results to patients, who might be spreading the virus in the interim.

The key part of the program, which has been in progress for 3 months, is RADx Tech, which uses an "innovation funnel" design to move applications from diagnostic companies quickly through multiple stages of review. About 15% to 20% of applications merit further review, the authors say. Of those initiatives, about one third receive NIH support for further development.

So far, more than 600 applications have been submitted by large and small companies. Of those, 27 applications made it into phase 1 testing, and one project is about to begin phase 2.

"The RADx-tech program offers extensive expertise and support to bring diagnostic technologies…from development to deployment," the authors write.

Point-of-Care vs Laboratory Tests

The report authors note that most tests to diagnose COVID-19 detect either viral RNA or viral antigens. Although the viral RNA tests are highly sensitive and specific, they require a large amount of laboratory space and complex equipment in a centralized lab. Results delivery can take hours or days, not counting the time to transport samples to the lab.

"For this reason, low-complexity molecular diagnostic point-of-care tests with rapid turnaround have substantial practical advantages," the authors explain. They note that a number of these tests have received emergency use authorization from the FDA, but they don't explain why they're not in widespread use.

Antigen tests, they add, can be done at the point of care and provide rapid results, "but they have lower sensitivity than most nucleic acid-based [viral RNA] assays."

Rapid Ramp-up of Testing

Another component of the NIH initiative, the RADx-Advanced Technology Platform (RADx-ATP), is designed to support companies with existing point-of-care diagnostic technology already authorized by the FDA for COVID-19 testing. Successful applicants must have the ability to scale production to 20,000 to 100,000 tests per day by the fall.

The RAD-ATP program aims to expand the testing capacity of high-throughput labs, also known as "mega-labs," to 100,000 to 250,000 tests per day. The authors suggest that "next-generation sequencing" can help the mega-labs make this leap, but they don't say whether the technology is ready for commercial use.

The RADx Radical arm of the NIH program focuses on nontraditional diagnostic approaches that have a longer time horizon than the other efforts.  RADx Radical will evaluate home-based testing and the repurposing of existing technology for testing COVID-19, among other things. The initiative will also support projects that use biological or physiologic biomarkers to detect an infection or prevent the severity of disease. Some of these technologies will take more than 6 months to develop, the authors note.

The program's fourth component, RADx Underserved Populations (RADx-UP), will establish community projects to improve access to testing in underserved and vulnerable populations, including racial and ethnic minorities that have borne a disproportionate burden of disease and mortality from COVID-19. In cooperation with these communities, the authors write, NIH plans "a series of interlinked, pragmatic implementation science projects at multiple sites across the country" to determine the best ways to care for these populations.

The distribution and implementation of new kinds of tests will be critical. "We anticipate coordinating closely with Operation Warp Speed," the authors say, referring to the Trump administration's effort to support the development and distribution of COVID-19 vaccines. In addition, the NIH will be "leveraging the logistic expertise of the Department of Defense" in some unspecified way.

The NIH officials foresee a "burst of increased testing capacity by the fall of 2020." However, "the challenges are considerable, and the timetable is truly daunting," they observe.

One of these challenges, they note, is that many smaller diagnostic companies lack expertise in the digital health platforms that provide connectivity among test results, electronic health records, and public health organizations. COVID-19 test results must be transmitted not only to patients, but also to state and local public health authorities, using national interoperability standards and common data elements.

National Supply Registry

AdvaMed's COVID-19 diagnostic supply registry addresses another health information technology need that has emerged in the course of the pandemic: the lack of information about where governments and healthcare providers can obtain COVID-19 testing supplies and equipment.

"It is absolutely vital to our nation's health and economic recovery that we have sufficient supplies to test everyone who needs it, and, just as important, to know where these supplies are so we can get them where they are most needed," said AdvaMed CEO Whitaker. "This national registry will be a crucial tool for federal and state authorities as they work to protect both patients and health care providers and move to reopen the US economy."

The registry will compile information from diagnostic companies along with publicly available data on daily tests performed to create a centralized and standardized COVID-19 diagnostic supply registry. The registry will provide weekly state- and national-level updates on the number of molecular, antigen, and serology (antibody) tests shipped in the United States.

AdvaMed is launching the registry in partnership with 13 commercial diagnostics manufacturers: Abbott, Becton Dickinson, bioMérieux, Bio-Rad, Beckman Coulter, Cepheid, Hologic, Ortho Clinical Diagnostics, QIAGEN, Roche Diagnostics, Sekisui Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific.  

The registry's first publicly released dataset shows that since the beginning of the pandemic, more than 65 million tests have been manufactured and shipped nationwide, according to AdvaMed.

NEJM. Published online July 22, 2020. Full text

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