At a recent public workshop, FDA's Office of In Vitro Diagnostics and Radiological Health addressed the need for FDA to develop a regulatory system for next generation sequencing ("NGS") tests. Sometimes referred to as "high throughput sequencing," NGS tests sequence large segments of DNA to identify genetic variants that may lead to disease. FDA acknowledged a wide spectrum of options for regulating NGS tests but ultimately pointed to a white paper in which the agency described its marketing authorization for an NGS instrument and its related reagents and assays. In that case, the company had used representative variants to demonstrate test performance, rather than methods requiring assessment of the enormous number of genetic variants detected by the tests. FDA plans to continue to use this approach in the future, along with other "novel and efficient approaches."
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