ASH Clinical News May 2015 | Page 64

Demystifying the Lab FIGURE. Schematic Comparison of Exome and Genome Sequencing Panel A shows the targeted nature of exome sequencing, with sequence reads concentrated over the coding portions of genes. This is in contrast to genome sequencing, shown in Panel B, in which the sequence reads are nearly randomly distributed over the entire genome. Each approach has advantages over the other, some of which are listed in the two panels. only want to know about one particular mutation and don’t need to spend the time or money on a broader panel.” A laboratory must have specialized equipment to perform NGS, and physicians also must be trained to interpret the data and develop appropriate therapeutic strategies for a wide range of molecular subtypes.6,7 For this reason, “WGS is still primarily in the realm of research since we don’t know how to interpret the overwhelming majority of what we find,” Dr. Bejar said. WES: An Unbiased Approach “Even if we were to perform WGS on a patient or that patient’s tumor, we would likely restrict our analysis to mutations whose implications are best understood,” he added. “These are almost entirely in protein coding regions, which are much better covered by WES.” WES is an unbiased way to examine every protein coding region, which allows hematologists to locate mutations and polymorphisms that they were not initially looking for. Reprinted with permission from The New England Journal of Medicine. (Source: Biesecker LG, Green RC. Diagnostic clinical genome and exome sequencing. N Engl J Med. 2014;370:2418-25.) since disruptive mutations can occur almost anywhere along the length of a gene,” Dr. Bejar said. Which Genomic Panel Should You Choose? The goal of genomic studies is to improve diagnostic precision and patient outcomes, but establishing the best circumstances for their use remains a challenge. “As always, the clinical picture is the most important factor in determining which test is appropriate,” Dr. Welch said. “The physician must understand what question is being asked and then apply the best test to answer it.” There are no cut-and-dried rules for when to apply a specific test, but the experts interviewed for this article provided some guidance about which test to use when. WGS: Too Much Information to Handle? WGS is most appropriate when structural variants or non-coding mutations are suspected, or when there is uncertainty about 62 ASH Clinical News which chromosome position to evaluate. But it may be an information overload. “Ideally, we would use WGS all of the time, as it is intended to capture all of the genomic DNA information,” Dr. Slager noted. “However, the current infrastructure is not able to handle such a large number of samples with a quick enough turnaround for clinical practice (e.g., within 1-2 days for results).” Dr. Slager also pointed out that, even when the infrastructure for WGS is in place, it might not be warranted for analysis of a specific genomic region known to be cancer-related, such as a gene or pathway. “Simpler genotyping panels would get the information easily and quickly without the overhead that comes with managing all the data generated from WGS technologies.” Dr. Bejar agreed that a more targeted approach is useful for quickly detecting a specific mutation, such as the JAK2 V617F mutation in a patient with polycythemia vera. “In that scenario, we really SNP Genotyping: A Happy Medium? “At the moment, WGS is not well suited for routine clinical use. It’s more expensive and often less sensitive than other approaches. This may change as sequencing becomes cheaper and our ability to interpret what we find grows,” Dr. Bejar said. “Even WES is overkill in most clinical situations.” Cost also remains a significant factor when deciding which genomic test to use. WGS is the most expensive approach and not yet cheap enough for routine clinical use, with SNP genotyping as the most affordable option. He suggested that for most diseases, including cancers, targeted sequencing of specific genes is the sensible choice for obtaining high coverage at relatively low cost. “SNP genotyping arrays that look at SNPs across the genome remain useful in some clinical scenarios but are rapidly being eclipsed by the falling cost of WES and other targeted sequencing techniques.” The Present and the Future of Genomics One challenge with the routine use of genomic profiling today is that the cost of computing is not falling as quickly as the cost of sequence production, so computing power is not sufficient to deal with all the raw data being generated by NGS.5,7 “We are entering a phase when the analysis costs more than the sequencing production,” Dr. Welch pointed out. “Most genomic panels in clinical use focus on the exons of a small number of target genes. In cancer, these are typically oncogenes and tumor suppressor genes that are recurrently mutated – a subset of which will have important clinical implications,” Dr. Bejar said. “As the cost of targeted sequencing has fallen, this approach has become increasingly favored in the clinical setting,” Dr. Bejar said. Recently, at the 2014 ASH Annual Meeting, Janine Pichardo, BS, from the department of Pathology at Memorial Sloan Kettering Cancer Center in New York, and researchers demonstrated the clinical utility of this approach. Using a commercially available NGS-based gene panel targeting hundreds of cancer-related genes, investigators were able to diagnose a wide spectrum of hematologic malignancies known to be difficult to diagnose, subclassify, and risk-stratify with conventional methods.9 “Our study shows that a broad sequencing panel targeting single nucleotide variations, insertions, deletions, copy number alterations, and translocations may improve diagnostic accuracy in 10 to 15 percent of patients with hematologic malignancies,” Ms. Pichardo said. “In our opinion, physicians treating hematologic malignancies should make every effort to integrate comprehensive targeted genomic profiling to the care of patients with hematologic malignancies.” —By Amy Dear ● REFERENCES 1. Ciardiello F, Arnold D, Casali PG, et al. Delivering precision medicine in oncology today and in future-the promise and challenges of personalised cancer medicine: a position paper by the European Society for Medical Oncology (ESMO). Ann Oncol. 2014;25:1673-78. 2. Garraway LA, Verweij J, Ballman KV. Precision oncology: an overview. J Clin Oncol. 2013;31:1803-05. 3. Genetics Home Reference. Handbook: Help Me Understand Genetics. Lister Hill National Center for Biomedical Communications; U.S. National Library of Medicine; National Institutes of Health; Department of Health & Human Services; 2015. Accessed April 23, 2015 from http://ghr.nlm.nih.gov/handbook.pdf. 4. American Cancer Society. Family Cancer Syndromes. Accessed April 23, 2015 from www.cancer.org/ cancer/cancercauses/geneticsandcancer/heredityand-cancer. Revised June 25, 2014. 5. Merker JD, Valouev A, Gotlib J. Next-generation sequencing in hematologic malignancies: what will be the dividends? Ther Adv Hematol. 2012;3:333-39. 6. Braggio E, Egan JB, Fonseca R, Stewart AK. Lessons from next-generation sequencing analysis in hematological malignancies. Blood Cancer J. 2013;3:e127. 7. Johnsen JM, Nickerson DA, Reiner AP. Massively parallel sequencing: the new frontier of hematologic genomics. Blood. 2013;122:3268-75. 8. Edenberg HJ, Liu Y. Laboratory methods for highthroughput genotyping. Cold Spring Harb Protoc. 2009; (11):pdb.top62. 9. Pichardo JD, Feldstein JT, Arcila M, et al. A comprehensive clinical next generation sequencingbased assay can impact hematopathologic diagnosis in a significant subset of patients with hematologic malignancies. Abstract #2984. Presented at the ASH Annual Meeting, December 7, 2014. May 2015