On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which included announcements intended to help clinical laboratories and test kit manufacturers get tests to patients more quickly.
On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. Key components of the announcement, which follows on the heels of recent FDA announcements intended to increase patient access to testing, include the following:
Authorizing states to allow high-complexity clinical laboratories to offer COVID-19 tests without first obtaining an Emergency Use Authorization (EUA). On March 12, 2020, FDA announced that it would allow New York State to authorize certain laboratories in that state to offer validated COVID-19 testing without obtaining an EUA from FDA, provided such laboratories met certain requirements established by the state. The FDA’s March 16, 2020 announcement extends similar authority to the remaining 49 states, provided such states affirmatively choose to take responsibility for tests developed and used by laboratories in their states. The process will be established individually by each state and will not necessarily need to mirror New York State’s process. States may allow clinical laboratories that meet Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements to perform high-complexity testing in those states (1) to engage directly with appropriate state authorities instead of with the FDA, and (2) to offer their tests without first obtaining an EUA.FDA requests that states notify the agency if they intend to use this flexibility to expedite COVID-19 testing. While FDA will not review the process adopted by any individual state to review laboratory requests to begin testing, the agency expects states to require laboratories to validate their tests prior to clinical use.
Authorizing manufacturers to distribute validated COVID-19 test kits prior to submission of an EUA. Expanding the policy FDA previously announced for CLIA-certified clinical laboratories that perform high complexity testing, FDA will now allow commercial test kit manufacturers to distribute COVID-19 test kits for a reasonable period of time after the manufacturer’s validation of the test, provided that the manufacturer (1) is preparing an EUA request and (2) provides instructions for use of the test and data about the test’s performance characteristics on the manufacturer’s website. Following completion of assay validation, manufacturers should notify FDA (e.g., via email to CDRH-EUA-Templates@FDA.HHS.GOV) that their assay has been validated and that they intend to begin distribution. FDA requests that manufacturers submit a completed EUA request within 15 business days of notifying FDA that the assay has been successfully validated. To facilitate manufacturer preparation of the EUA, FDA has posted a template submission on its website. If FDA is not able to authorize an EUA, FDA would expect the manufacturer to suspend distribution and conduct a recall of the test.
Providing recommendations for development of serology tests. Prior to March 16, 2020, FDA guidance primarily focused on nucleic acid-based tests for the detection of COVID-19. However, the agency also acknowledged that some commercial manufacturers and laboratories are seeking to develop antibody tests for COVID-19. FDA notes that it does not intend to object to the development and use of COVID-19 antibody tests, provided the test has been validated, the test developer provides notice to the FDA, and warning statements are included with the tests. Such warnings may include statements that the test has not been reviewed by FDA, that negative results do not rule out COVID-19 infection, that results from antibody testing should not be used as the sole basis to diagnose or exclude COVID-19 infection or to inform infection status, and that positive results may be due to past or present infection with non-COVID-19 coronavirus strains. FDA also provides specific recommendations for antigen detection and serology validation studies, including limit of detection/analytical sensitivity, cross-reactivity/analytical specificity, microbial interference or clinical agreement studies, as may be applicable.