Health Law Daily FDA issues guidance on development of coronavirus tests
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Friday, May 15, 2020

FDA issues guidance on development of coronavirus tests

By Wendy Biddle, J.D.

FDA lays out four policies that help with fast-tracking COVID-19 tests.

The FDA issued a final guidance on the policy for coronavirus tests. The guidance includes four policies that will help facilitate the development and use of SARS-CoV-2 tests. Two policies center around emergency use authorization (EUA) submission to the FDA or bypassing the EUA when the test is developed under the state’s authority; one policy relating to commercial manufacturers rapid distribution of diagnostics for specimen testing while EUA is being prepared; and a policy regarding the use of serological testing (Notice, 85 FR 29461, May 15, 2020).

Labs pursuing EUA. The first policy the guidance explains involves certified labs that are seeking to develop and perform diagnostic tests to detect the SARS-CoV-2 virus and want to pursue an EUA for the tests. The policy lays out that all clinical tests should be validated. After validation, the labs should notify the FDA that their assay has been validated and include a statement that the FDA’s independent review is pending. The labs should then use a template the FDA has provided to submit the EUA, which the FDA will preliminarily review to identify issues with the performance data. While waiting for the FDA determination on the EUA request, the labs should obtain confirmation of the first five positive and first five negative clinical specimens. If the results cannot be confirmed the lab should notify the FDA that their prior test results may not be accurate.

State-authorized labs. Certain labs in New York began patient testing to increase availability of COVID-19 tests at the request of the New York State Department of Health. On March 13, 2020, the President issued a memorandum stating that the states can authorize labs within a state to develop and perform tests. In accordance to that memo, the FDA established a policy that allows states to authorize labs within their state to develop their own COVID-19 tests and perform specimen testing where tests are not submitted to the FDA and the lab does not have to submit an EUA request. The FDA requests that states notify them if they choose to use this method to expedite testing. The FDA will not review the process the states adopt. The FDA does expect that the state oversight process will require that labs validate the tests prior to use.

Diagnostic tests. This policy applies to manufacturers that want to develop and distribute diagnostic test kits to lab or healthcare workers for point-of-care testing. The FDA does not intend to object to commercial manufacturing of test kits for a reasonable period of time, if the test has been validated and the manufacturer notifies the FDA while preparing the EUA request. Generally this policy follows the same guidelines as the lab policy, with the exception that the FDA recommends that the manufacturers submit a completed EUA request within 15 business days of the notification to the FDA. If the manufacturer does not submit within that time frame, the FDA will remove the manufacturer from its website.

Serology tests. The FDA lastly issued a policy on antibody tests, or serology tests. The FDA does not intend to object to a commercial manufacturer’s development and distribution of serology tests where the test has been validated, and while the manufacturer is preparing its EUA request. The manufacturer must notify the FDA of validation. The FDA suggests that the completed EUA request be submitted within 10 business days of the notification.

Lastly the FDA has made available EUA templates on its website to help with the preparation, submission, and authorization of an EUA.

MainStory: TopStory FDAGuidanceNotices FDCActNews ClinicalNews Covid19 PrescriptionDrugNews SafetyNews

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