BIO Comments Following FDA Public Meeting: Ultra High Throughput Sequencing for Clinical Diagnostic Applications

BIO commends the FDA for prospectively seeking input from industry to ensure that the regulatory environment is supportive of the rapid technological advancement of clinical diagnostic applications. The approach to assessing the analytical validity of next generation sequencing clinical diagnostic applications must be both clear and flexible enough to allow for the variability among the platforms. Further, assessment of the analytical validity and clearance of this technology should focus on the individual platform, rather than proceeding on a gene-by-gene basis. FDA should work closely with industry to develop standards or standardized methodologies to ensure that they are accurate and reliable, but also clear and flexible enough to ensure that innovation in this area is not inhibited.