By Leah S. Poniatowski, J.D.
Labs certified for high-complexity testing given green light to use in vitro diagnostics before formal FDA authorization in order to make COVID-19 testing widely available.
In light of the public health emergency presented by the novel coronavirus (COVID-19), the FDA is allowing certain laboratories to use in vitro diagnostics which were developed and validated without FDA emergency use authorization in order to ensure the wide availability of testing, according to non-binding guidance issued by the FDA (Notice, March 6, 2020, 85 FR 13169).
Public health declaration. The Secretary of the Department of Health and Human Services determined on February 4, 2020, that the novel coronavirus originating from China presents a public health emergency. The CDC laboratories developed a diagnostic assay, which was issued an emergency use authorization (EUA) from the FDA on the same date. Despite actively working with other diagnostic developers, the FDA determined that severe health consequences coupled with the rapid spread of the virus demands testing capabilities that cannot be met at present.
Pursuant to section 564 of the FD&C Act, the FDA issued the present guidance vis-a-vis diagnostic methods for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) before formally granting emergency use authorization in light of the present emergency circumstances.
Test validation. In order to help ensure that COVID-19 tests are validated before being implemented, the FDA provided several recommendations concerning the testing process. First, the FDA addressed documenting the limit of detection and provided a recommendation as to how to test dilution series. Second, if a laboratory does not have any known positive samples for testing the virus, the FDA also provided guidance as to how the laboratories should conduct testing under those circumstances. Third, the FDA recommended that laboratories also document the results of in silico analysis results against publicly available sequences of the virus. Finally, the FDA addressed cross-reactivity, stating that in silico analysis of the assay as compared to other common flora and pathogens is sufficient and that recognized laboratory procedures should be followed for cross-reactivity testing.
FDA notification. Upon validating an assay, the FDA recommends that laboratories notify the FDA and provide details as described in the guidance text. Additionally, laboratories should immediately notify the appropriate public health agency of all positive results. With respect to test reports, they should include a statement to the effect that the test has been validated but is awaiting FDA review.
EUA requests and testing. The laboratories in scope of this guidance are expected to pursue an EUA from the FDA. The agency has prepared a template specific to COVID-19, which can be obtained by contacting the FDA at the email address provided in the guidance or from the FDA website. The FDA also recommended that confirmation of the first five positive and the first five negative clinical specimens be confirmed by another laboratory while waiting for FDA authorization.
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