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

“AACC commends the U.S. Senate for passing the Coronavirus Aid, Relief, and Economic Security (CARES) Act yesterday, which will provide vital support to Americans in the midst of the coronavirus outbreak. In particular, we applaud the Senate for responding to the concerns of the clinical laboratory community and revising this legislation to ensure that it provides insurance coverage for all COVID-19 tests, regardless of whether or not they are performed under an FDA emergency use authorization (EUA). Last week, FDA eliminated its unnecessary and cumbersome EUA requirement for COVID-19 tests for those labs located in states willing to assume oversight responsibilities for the test, a positive change that will enable more labs to create and perform these tests. However, this inadvertently created a new problem, because an earlier version of the CARES Act only provided coverage for COVID-19 tests performed under an EUA. AACC has worked intently to educate lawmakers about this discrepancy in collaboration with Sens. Lamar Alexander, R-Tenn., and Pat Toomey, R-Pa., who championed this issue in the Senate. We would like to thank Sens. Alexander and Toomey for their prompt action, as well as the other legislators who worked to align this bill with FDA’s new guidance. The final legislation will help to ensure that all patients have access to COVID-19 testing, which is crucial to bringing this outbreak under control. We now urge the House of Representatives to move swiftly to pass this bill and send it to the President for his signature.”

Since the beginning of the COVID-19 outbreak, AACC has been providing laboratory professionals with the latest guidelines from CDC and FDA to help them to create and validate accurate, reliable tests for COVID-19. AACC has also created a directory of U.S. clinical laboratories that are, or will be, performing COVID-19 tests and that is designed to help healthcare providers rapidly identify COVID-19 cases.

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