FDA Center for Devices and Radiological Health officials reflect on COVID diagnostics approach

  • November 20, 2020

On 4 FEB 2020, just weeks after the first case of COVID-19 was detected in the US, FDA issued an emergency use authorization (EUA) for a test developed by the Centers for Disease Control and Prevention (CDC).  However, after issues with the CDC’s rollout of the test and the need for additional test capacity, FDA opened the door for clinical laboratories and commercial manufacturers to develop and perform their own tests.

Since then, the number of tests available has proliferated, with FDA counting 243 tests authorized under EUAs as of 08 SEP 2020, including nearly 200 molecular diagnostics, dozens of antibody tests and four (4) antigen tests.

While touting FDA’s actions to spur the development of additional tests for COVID-19, Jeffrey Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Timothy Stenzel, Director of the Office of In Vitro Diagnostics and Radiological Health, write that some of FDA’s policies led to many poorly validated tests entering the market.

Initially, FDA said it would not object to certain clinical laboratories validating and using their tests for 15 days before submitting an EUA request.  “Although this approach resulted in earlier test availability, the EUA’s less-rigorous evidence standard, coupled with delayed FDA review, allowed the use of several [laboratory developed tests] LDTs that ultimately proved to have performance problems or to be poorly validated,” Shuren and Stenzel write.

The two (2) officials note that in an analysis of 125 EUA requests from clinical laboratories, 82 had design or validation issues, and that similar issues were seen with tests developed by commercial manufacturers.

In future emergencies, Shuren and Stenzel say they believe the US government and other international actors should establish reference specimens “as soon as a public health threat emerges.”

The two also argue that, “It would be more effective to authorize a small number of well-designed, well-developed, and validated tests run on common high-throughput platforms, followed by a few point-of-care tests, all of which are manufactured in large quantities, than to simultaneously develop and authorize scores of diagnostics.  Such diffuse efforts are an inefficient use of resources.”

Additionally, Shuren and Stenzel say that “common approaches to validating test design and performance” are needed and call for a “common legislative framework to ensure that all clinical tests are accurate and reliable.”  While FDA has long argued that it has oversight over LDTs, the Department of Health and Human Services (DHHS) in August issued a notice stating the Agency “will not require premarket review of laboratory developed tests (“LDTs”) absent notice-and-comment rulemaking.”

REFERENCE:  RAPS Regulatory Focus (News Articles 2020 9); 09 SEP 2020; Michael Mezher

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