The Need for FDA to Regulate Poorly Performing Commercial COVID-19 Tests Should Not Hinder Laboratory-Developed Tests

WASHINGTON, April 14, 2020 /PRNewswire/ --

Statement attributable to:
Carmen L. Wiley, PhD
President, American Association for Clinical Chemistry

"When the COVID-19 outbreak first reached the U.S., the country's response to the epidemic was hamstrung by extensive and unnecessary regulations causing a lack of testing capacity. To address this situation, the Food and Drug Administration (FDA) loosened its emergency use authorization (EUA) criteria for commercial COVID-19 tests, as well as for non-commercial tests developed in-house by laboratories (known as laboratory-developed tests). This decision has greatly increased the availability of COVID-19 tests, but an unfortunate new consequence is that reports are now surfacing of unreliable commercial COVID-19 serological tests. While most in vitro diagnostic companies operate on good faith and in full transparency, worrying reports have also emerged about a small number of unreputable diagnostic companies that are taking advantage of FDA's relaxed rules, and marketing COVID-19 tests under the false claim that these tests are FDA authorized. Both of these issues are major concerns, and AACC hopes that FDA will be able to strike a balance between enabling COVID-19 tests to quickly come to market while ensuring these tests are safe and accurate.

"However, we at AACC also want to emphasize that these problematic commercial tests are not the same as laboratory-developed tests?and that we still strongly support FDA's decision to step back from regulating lab-developed tests for COVID-19. To clarify the distinction between commercial and lab-developed tests: Commercial test kits are created by medical device manufacturers and sold to various healthcare entities, and have always been subject to FDA review. Laboratory-developed tests, on the other hand, are only used internally by the lab or hospital that created them, and are not marketed or sold to other entities. These tests are subject to stringent regulations under CMS and CLIA, which require lab directors?many of whom are AACC members?to validate the accuracy of these tests before performing them. If FDA revisits its EUA criteria for commercial COVID-19 tests, AACC urges the agency to maintain its hands-off approach to lab-developed COVID-19 tests, which are already validated by lab experts and are needed more than ever now that it is becoming clear that not all of the commercial tests are performing up to par."  

About AACC
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

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Christine DeLong
AACC
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Molly Polen
AACC
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[email protected] 

SOURCE AACC