COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues New Guidance for Test Developers on How to Plan for Genetic Variants

FDA maze of regulations

As COVID-19 variants threaten to affect some COVID-19 tests, FDA releases new guidance on how to stay ahead of viral mutations

The US Food and Drug Administration (FDA) issued new guidance for COVID-19 test developers as SARS-CoV-2 variants become a more prominent concern. The purpose of this guidance is to help test manufacturers monitor changes in how variants could affect their tests, and design new tests that will address these COVID-19 variants.

The “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests” primarily provides recommendations for molecular diagnosis test developers but also addresses antigen and serology tests. The new guidelines are intended to provide nonbinding recommendations that will assist test developers as they navigate the emerging variants.

Toward the performance of diagnostic tests, three main components are addressed by this new guidance. These suggestions include:

  1. Considering designs that will minimize the impact of viral mutations on new or existing tests;
  2. Routinely monitoring for viral mutations and new variants that could impact test performance; and
  3. Clearly conveying any test limitations through the test’s labeling.

The guidance document provided by the FDA provides in-depth recommendations on how to achieve these suggestions and how to approach addressing variant-related changes to existing emergency use authorizations (EUAs).

The new FDA guidance also provides several resources for clinical laboratories for monitoring the spread of variants. Clinical laboratory leaders wishing to see this guidance in its entirety can do so here.

Related Resources:

FDA: Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests