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NIH Aims to Streamline FDA Authorization of High Impact OTC COVID-19 Tests Through $70M Program


NEW YORK – Aiming to speed more over-the-counter COVID-19 tests to market, the National Institutes of Health Rapid Acceleration of Diagnostics initiative has established a new effort to support review and validation of such tests.

Announced at the end of October, the initiative, called the Independent Test Assessment Program, or ITAP, will provide independent validation, clinical studies, and data collection to support US Food and Drug Administration Emergency Use Authorization applications for OTC COVID-19 tests.

The program, which is supported by $70 million in funds from NIH, will focus primarily on tests currently being produced at scale for sale outside the US that could potentially be brought to the US to address the country's problems with a lack of access to inexpensive OTC COVID-19 tests, said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering and leader of the RADx Tech program.

"The question is, do we have tests [outside the] US that could be produced at the scale of tens of millions per month, and how fast could they get into the US," Tromberg said. "Our basic criteria [for participating in the program] are: You are manufacturing at scale somewhere in the world, and people are buying and using your tests. We're only doing it really for tests that could be impactful quickly."

Since the start of the pandemic, the RADx program has been funding and otherwise supporting the development of various COVID-19 testing technologies including OTC rapid tests. This has given it an infrastructure that Tromberg said could help it move existing non-US tests through the FDA's regulatory process. He noted that tests developed within the RADx program account for 32 EUAs.

"Because RADx has been evaluating tests in an accelerated way with our validation core and our clinical studies core, we can parallelize clinical studies," he said. "We can work with contract research organizations, we have our own laboratory network, we have IRBs. We have laboratories with 100,000 banked samples and enormous expertise in data analysis."

The program was inspired in part by a program launched by the National Cancer Institute earlier in the pandemic to evaluate the performance of COVID-19 serology tests, Tromberg said.

There is good reason to think some test suppliers with substantial capacity have avoided the US market due to the stringency of the FDA's EUA process compared to regulations in some other geographies.

For instance, speaking recently to 360Dx, an FDA official indicated that the agency has not gotten submissions from many of the companies offering tests in countries like Germany, where OTC COVID-19 tests are abundant and far less expensive than in the US.

"They may be fine tests," the official said. "We can't compel folks to come to the US."

At the beginning of October, the FDA authorized Acon Laboratories Flowflex COVID-19 home test for OTC sales and noted that authorization of the test, which had been available in other countries for months, "was expected to double rapid at-home testing capacity in the US" in the near term and that the San Diego-based company planned to be producing 200 million tests per month by February 2022.

The ITAP will also help manufacturers of tests with an FDA EUA for point-of-care use apply for an EUA for OTC use.

The goal is to "optimize the process, introduce efficiencies, potentially parallelize some of the studies so that, for instance, the analytical performance studies and the clinical studies get off the ground at the same time," Tromberg said. "I think we can shave many weeks off of the EUA process."

In addition to helping streamline the process of collecting analytical and clinical data, the program would also speed the overall EUA process by ensuring that companies are submitting complete and appropriate applications to the FDA, Tromberg suggested. He noted that he had discovered through his work with test vendors in the RADx program that this is a stumbling block for many.

"Some companies, some of them big companies, are surprisingly naïve about [EUA applications], and particularly over-the-counter authorizations," he said.

Tromberg noted that, in particular, the FDA is always concerned about relying on company-submitted data. He added that his experience with RADx has borne out those concerns.

"Every company that has applied [to RADx] has submitted their own data for us to evaluate and then [we] try to make a decision on whether we are going to invest in them," he said. "There is a not a single company that has come to us initially with data and claims on sensitivity and specificity that has stood up in our validation core and come out with the same performance."

In many cases the performance figures provided by the company were better than what the RADx evaluation found, though in several cases the RADx evaluation showed a higher performance level than what the vendor data indicated, Tromberg said.

He declined to say how many tests the program would be able to evaluate at a time and how long the evaluation process would take, but said that he believes it will be able to evaluate products from multiple companies in parallel.

He said the program is accepting inquiries from manufacturers interested in participating and also reaching out to invite vendors that could be good candidates.

"There are some pretty obvious ones that are big manufacturers that have sold hundreds of millions of tests around the world," he said.