The utilization of next-generation sequencing (NGS)—which can examine millions of DNA variants at one time—is now being regulated. The FDA has released 2 draft guidances regarding the use of these NGS-based tests, which can be used to inform risk and treatment decisions across multiple tumor types.
The first draft guidance, titled, “Use of Standards in FDA’s Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” provides recommendations for designing, developing, and validating NGS-based tests for rare hereditary disease.
The second draft guidance, titled, “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” describes an approach wherein test developers may rely on clinical evidence from FDA-recognized public genome databases to support clinical claims for their tests and provide assurance of accurate clinical interpretation of genomic test results.
The guidances are part of the of the FDA’s engagement in the Precision Medicine Initiative (PMI), created by the White House in early 2015.
“Targeting the right treatments to the right patients at the right time is the goal of the President’s Precision Medicine Initiative,” said FDA commissioner Robert Califf, MD, in a statement. “Soon, patients will have a much more complete picture of their health than in the past, informed by their genetic and genomic makeup.
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