FDA sets down final guidance on next-gen sequencing tests; third draft on in vitro diagnostics

Scott Gottlieb
FDA Commissioner Scott Gottlieb says the new guidances "provide a modern and flexible framework to generate data needed to support the FDA’s review of NGS-based tests." (FDA)

The FDA has issued a pair of final guidances on developing and validating next-generation gene sequencing tests (NGS) and a third draft guidance related to in vitro diagnostics (IVD) in an effort to accelerate the submission process for investigational cancer drugs and biological products.

The two final guidances center on the use of public genetic variant databases to support the clinical validity of genetic and genomic-based tests; and the design, development, and analytical validation of NGS tests in diagnosing germline diseases.

"As disease detection technologies rapidly evolve, so too must the FDA’s approach to reviewing these new innovations," FDA Commissioner Scott Gottlieb, M.D., said in a statement. "The new policies issued today provide a modern and flexible framework to generate data needed to support the FDA’s review of NGS-based tests, and give developers new tools to support the efficient development and validation of these technologies."


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The new and draft guidelines are part of the FDA’s efforts to reduce the administrative burden on sponsors and FDA staff by outlining circumstances under which sponsors may be able to include information about an investigational IVD in the Investigational New Drug (IND) application submissions. The guidance now allows the premarket information related to the investigational drug and the investigational IVD to be contained in a single IND application.

By consolidating the information about both the investigational drug and device into the same application, the agency hopes to nurture a more efficient review process and establish the scientific relationship between the drug and the diagnostic being used to select patients for treatment. 

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