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FDA to Harmonize COVID-19 Data with New Terminology Codes

NEW YORK – In a bid to standardize the reporting of diagnostic test results and improve data gathering and analysis, the US Food and Drug Administration said it plans to develop new terminology codes.

The agency described a program to develop the new codes on Wednesday during its fifth weekly town hall meetings with SARS-CoV-2 diagnostic developers.

Sara Brenner, associate director for medical affairs and chief medical officer at FDA, said during the town hall that laboratory data harmonization is "sometimes an overlooked, but really essential aspect of understanding how many infections we have in the country at any given time."

As part of a public-private partnership Brenner said the FDA and the Association of Public Health Laboratories, along with manufacturers, labs, standards developers, the US Centers for Disease Control and Prevention, and other agencies across the US Department of Health and Human Services are working to ensure that molecular diagnostic testing for SARS-CoV-2 as well as serological testing "can be described the same way from the get go, right out of the lab."

The detection of the emergence, prevalence, and spread of infectious diseases is essential in efforts to protect and preserve public health at the local, state, and national levels, she said. Surveillance efforts can be hindered by an inability to pool and compare data unless consistent electronic reporting practices are adopted, she added.

The codes to be developed could draw from several initiatives already completed or underway to harmonize diagnostic data reporting. FDA's Center for Devices and Radiological Health has standardized diagnostics terminology that it encourages manufacturers to use in the submission process. On its website, FDA also refers to Clinical Data Interchange Standards Consortium (CDISC). This standards developing organization announced a task force to create guidance on standardizing COVID-19 research data last month, which it noted the FDA was aware of and observing. CDISC also recently made interim COVID-19-specific terminology available.

The APHL has also described collaboration with public health partners, federal agencies, and standards development organizations "to develop messaging and data standards while integrating technology from the latest platforms."

Brenner said that for SARS-CoV-2 diagnostics, there has been inconsistency in how tests are described, such that tests meant to give the same type of answer are often described in different ways.

This in turn results in "ambiguities in the meaning of that information, as well as an inability to roll it up or aggregate that data, understand it, and analyze it collectively," she said.

Brenner said that "terminology codes" are currently being developed and assigned to each test that will represent the question that the test asks of the specimen, and the range of answers that can be generated from that test.

"This information will be extremely important in terms of addressing shortages for testing, ensuring that tests are working the way that they're intended to, better understanding their performance … and expediting ways to validate and interpret how therapeutic or clinical interventions are actually working in terms of health outcomes," said Brenner.

Diagnostic developers looking for more information or interested in participating in the effort can reach the FDA at [email protected]

"Simply by describing our diagnostic tests the same way from the get-go, the data generated from those tests can be used to gather more detailed information in real time that will help us protect the nation and get back on our feet," Brenner said.