FDA delivers new guidance for test makers on dealing with COVID-19's emerging strains

coronavirus test tubes
The FDA has said it believes the overall risk to be low but that certain tests relying on a single string of the virus’s RNA could be more susceptible to new mutations than a diagnostic that searches for multiple genetic targets. (Getty/RossHelen)

As the U.S. passes a grim milestone with at least 500,000 deaths caused by COVID-19, the FDA is preparing to manage an ongoing and future threat from the disease: new viral mutations that may hinder the effectiveness of tests, treatments and vaccines.

The agency issued new guidance to biopharma companies, urging them to evaluate the potential impact of emerging strains on their products and outlining how to pursue changes as developers look to adapt in response.

At the beginning of this year, the FDA had warned the makers of gold-standard molecular diagnostics that—depending on changes in the coronavirus’s genome and the specific sequences used by a test to generate a positive result—some mutations may result in a higher rate of false negatives.

At the time, the agency said it believed the overall risk to be low but that certain tests, which may rely on a single string of the virus’s RNA, could be more susceptible to mutations than a diagnostic that searches for multiple genetic targets.

The new diagnostics guidance calls on molecular, antigen and antibody test developers to consider emerging coronavirus variants during the development process as well as after the product is on the market. In the future, the agency said it may require companies to do so as a condition for an emergency authorization or approval. 

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said the agency’s longtime head of its drug-focused center, Janet Woodcock, M.D., currently speaking as acting FDA commissioner.

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“We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products,” Woodcock added. “By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.”

The FDA made similar recommendations for the developers of vaccines and therapeutics and highlighted its past work against viruses that may produce new widespread mutations, such as the seasonal flu or HIV.

The agency also noted that the currently authorized vaccines made by Pfizer-BioNTech and Moderna continue to be effective against today’s coronavirus strains but they may have to be recalibrated in the future.