Current guidelines and recommendations place the responsibility of validating the bioinformatics pipelines (and ensuring reliability after update of any of its components) with the operator/quality manager of the test facility 32, 33, 39 . In fact, thus far, many different sets of benchmark materials and resources have been produced for local use or within collaborative endeavours (see 34). Benchmark datasets have also been used to compare different methods or tools 17, 82, 83 . The extent to which these datasets address the concerns described in this document is the subject of a case-by-case evaluation that may become crucial for a wide implementation of NGS technology for routine and regulatory use. An open and inclusive discussion on the different issues (described here or arising upon more detailed considerations) will be important for the development of a resource that can gain wide acceptance and use.