Clinical OMICS

JAN-FEB 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com January/February 2018 Clinical OMICs 43 AMP Guidelines to Improve the Entire NGS Workflow The increasing use of next-generation sequenc- ing (NGS) technologies has raised new challenges, especially regarding how cancer-as- sociated sequence variants are interpreted, how molecular results are reported, how oncology panels are optimized, and how bioinformat- ics pipelines are validated by different clini- cal laboratories. With this series of guidelines, AMP has provided the cancer genomics com- munity with appropriate tools and guidance to help standardize the process and better incor- porate the latest technological innovations in molecular pathology across the complete NGS workflow. AMP believes it is the responsibility of profes- sional organizations to establish guidelines for professional practice, and we routinely engage with other professional associations, such as ASCO, CAP, AMIA, and ACMG to publish evi- dence-based practice guidelines. Our members are among the early adopters and users of NGS technology in a clinical setting and have accu- mulated substantial knowledge and expertise. We convened and led a multidisciplinary, sub- ject matter expert working group to summarize current knowledge, expose challenges, and pro- vide guidance on how to incorporate NGS tech- nologies to improve patient care. All of the AMP guidelines published in The Journal of Molecu- lar Diagnostics are available for free download so that molecular professionals can share this information and promote best practices in lab- oratories around the world. ASCP, CAP, AMP, ASCO Guidelines on Molecular Biomarkers for the Evaluation of Colorectal Cancer This pivotal guideline report addresses the clin- ical use of molecular biomarkers in patients with early and advanced colorectal cancer. This guideline establishes standards for molecular biomarker testing that supports targeted ther- apy decisions and advance personalized care for patients with colorectal cancer, which is the second leading cause of cancer-related death in the U.S. for women and men combined. The report includes 21 guideline statements (eight recommendations, 10 expert consensus opin- ions, and three "no recommendation") based on evidence from a comprehensive literature review, which included more than 4,000 articles. The guideline supports mutational testing for genes in the epidermal growth factor receptor (EGFR) pathway to inform targeted therapy decisions as well as other biomarkers. Addi- tional recommendations are intended to stream- line molecular testing processes and contribute to improving patient outcomes. FEDERICO MONZON President Association for Molecular Pathology FDA Approvals for Diagnostics The FDA took several positive steps in 2017 in support of new next-generation sequenc- ing (NGS)-based tests designed to profile solid tumors. These multi-gene tests help bypass the sequential testing approach, which tests tumors one gene at a time and run the risk of depleting tissue, and help expedite selection of targeted therapies. The FDA's premarket approval of a small number of NGS tests marks a turning point for precision medicine and for patients who can benefit from them. One such companion diag- nostic that received FDA premarket approval in June is the Oncomine Dx Target Test, which is designed to simultaneously evaluate 23 genes clinically associated with non-small cell lung can- cer (NSCLC). Additionally, three of the genes on the test (ROS1, EGFR, and BRAF) are also used to identify patients who may be eligible for treat- ment with one of three FDA approved targeted therapies. This approval also underscores the value NGS can bring for better health outcomes, but there is more work to be done in 2018. The national coverage decision recently proposed by the Centers for Medicare & Medicaid Services is a major step forward for NGS-based testing, but there are other approaches, such as liquid biopsy testing, that also should be considered for the benefit they can bring to improve health outcomes.

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