%0 Journal Article %T Assessing the Value of Next-Generation Sequencing Tests in a Dynamic Environment %A Howard A. Burris %A Leonard B. Saltz %A Peter P. Yu %J About the Ed Book | ASCO Educational Book %D 2018 %R https://doi.org/10.1200/EDBK_200825 %X NGS-based testing is a technology in evolution¡ªevolving from completion of the human genome mapping in 2003, which at that time, relied on laborious older technologies, some of which, such as Sanger sequencing, remain the gold standard for DNA analysis. Instead of sequencing being performed one nucleotide at a time, genomic material is fragmented into shorter lengths of approximately 100 base pairs. These shorter fragments are sequenced in parallel, and much as a jigsaw puzzle is reconstructed by referring to a complete image, the short genomic sequences are mapped to one or more reference human genomes.1 The precision of this massively parallel sequence mapping is highly dependent on technical factors, such as the number of times that a nucleotide is repetitively sequenced (depth of coverage) and the computational algorithms used to map the nucleotide position. The pace of technologic evolution in genomics continues to accelerate, reducing cost and test turnaround time of NGS tests, while simultaneously increasing cost through the introduction of new technology, wider adoption of that technology, which may be premature, and downstream consequences on medical decision-making. The ultimate value of any diagnostic test is its impact or lack thereof on the clinical treatment of patients, which is dependent on knowing when to obtain the test in question and whether therapeutic choices exist that can be exploited. Just as genomic testing technology is in a continuous state of evolution, the pipeline of new therapeutics targeted to an expanding knowledge base of genomic and immunologic drivers of malignant behavior is increasing in parallel. The cancers of individual patients are also in a dynamic state, with clonal evolution and acquired resistance refuting a one-cancer, one-driver mutation model. These considerations illustrate the interdependency of factors that are relevant to assessing the value of NGS and other future genomic-based tests of the genome, transcriptome, proteome, and metabolome of individual patients with cancer. Ultimately, assessment of overall utility necessitates an understanding of the technical performance limitations of the test, the role of these tests in clinical trials enterprise design, and the use of these tests in routine patient treatment. INTRODUCTION Section: ChooseTop of pageAbstractINTRODUCTION <