WASHINGTON – In a letter to the Food and Drug Administration (FDA), AACC is urging the agency to allow clinical laboratories to develop coronavirus tests without going through FDA review. Lifting this regulatory requirement is key to ensuring that all patients have access to high-quality coronavirus testing and that healthcare workers have the tools they need to control the spread of this disease in the U.S.
The outbreak of coronavirus (which is officially known as coronavirus disease 2019 or COVID-19) is on the brink of becoming a worldwide pandemic, and the Centers for Disease Control and Prevention (CDC) has warned that an increase in U.S. cases is all but inevitable. In light of this, it is imperative for the U.S. to have coronavirus testing in place nationwide so that healthcare workers can contain the spread of this virus. Widely available coronavirus testing will enable healthcare workers to quickly identify, isolate, and treat infected patients—especially those who might currently be slipping under the radar because they have no direct links to China or to other infected individuals. However, the U.S. only has one coronavirus test developed by CDC available in a handful of cities right now, and labs encountered problems with this test during its initial rollout. This issue prompted the Association of Public Health Laboratories (APHL) to request an exemption from FDA requirements for public health labs so that these labs can quickly develop their own accurate coronavirus tests without the delay that would result from going through FDA review.
AACC strongly supports APHL’s request, but the association is concerned that this approach does not go far enough to protect Americans’ health. If the number of U.S. coronavirus cases spikes as in South Korea and Italy, testing requests could overwhelm public health labs, causing a delay in access to testing and resultant delays in diagnosis and care. To prepare for a potential surge in the demand for testing, AACC therefore recommends that FDA also exempt the many national and regional clinical laboratories that are separate from the public health system, but that also have the expertise and capacity to develop and perform coronavirus tests. These clinical laboratories are already subject to stringent regulations under the Centers for Medicare and Medicaid Services, and they have successfully developed, validated, and performed in-house tests for other serious public health conditions (such as HIV when it first emerged).
“AACC strongly recommends that FDA permit all qualified clinical laboratories to develop in-house tests for coronavirus without requiring these labs to submit their tests for FDA review,” said AACC President Dr. Carmen L. Wiley. “It is only by using the expertise of all our laboratory professionals that we will be able to ensure that American citizens have access to rapid, accurate coronavirus testing, and that clinicians will receive test results in a timely fashion to treat their patients.”
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.myadlm.org.