News, Policy & Media

24Feb

FDA issues new guidance on virus mutation impact on testing products

The Federal Drug Agency in the United States has issued fresh guidance on the impact of COVID-19 mutations on testing products. The guidance is intended to brief manufacturers on any implications of variants on the performance, usability or safety of testing products, whether antigen or antibody-based diagnostic tools. Product design considerations are included in the advice, along with ongoing monitoring suggestions regarding testing for COVID-19 during a time in which mutations are being picked up on and sequenced across the world.

Differences in testing methods could lead to differing impacts from mutations. The FDA has suggested that monitoring the impact of genetic variants on antigen tests and serology tests is not as straightforward as it is for RT-PCR tests, and other molecular tests. The Agency has already issued updated advice on vaccines and medicines which are addressing the SARS-CoV-2 virus for developers to consult. On a positive note, the regulator does not foresee any serious implications from the current set of identified mutations on testing products that would lead to an overhaul of the way the products are developed or utilised.

The Swiss-based health agency FIND carried out a study on the impact of viral mutations on diagnostic tests. It found ‘minimal’ alteration to the functioning of antigen and molecular diagnostics for coronavirus regarding the variants first found in Brazil, Kent and South Africa. Dr Janet Woodcock, acting FDA commissioner, said: “The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorised for emergency use to address emerging variants.” The FDA will continue to monitor genetic database information to assess if new variants affect test performance or the product development and post-authorisation stages.

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