Practical Issues in Identifying and Communicating Incidental and Unexpected Findings Arising from Mutation Analysis Utilizing Next Generation Sequencing for Clinical Oncology


Ryan Bender, Anatole Ghazalpour, Zheng Tan, Wenhsiang Wen, David Arguello, Joanne Xiu, Rebecca Feldman, Gargi Basu, and Zoran Gatalica


With the maturation of next generation sequencing platforms in clinical diagnostics the wealth of data that is generated in a time efficient and cost effective manner. On consequence of generation increased amounts of clinical data is the detection of incidental and/or unintended findings. A key consideration for many clinical labs is how to report or communicate these incidental findings to the ordering physician. Recently the ACMG has released a set of guidelines for reporting incidental findings; however, this article does not meet the needs of a genetics oncology laboratory on several fronts. Therefore, it is essential to identify and adopt a set of standards for reporting incidental findings detected in tumor samples that addresses the special needs of personalized medicine in oncology.

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