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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40 Clinical OMICs January/February 2018 Pembrolizumab Approval for MSI-high/dMMR Tumors This year, for the first time, we have seen the approval of a cancer therapy based solely on a biomarker, independent of the cancer 's tissue of origin. Historically, cytotoxic cancer therapies have been approved for individual diseases, on a disease-by-disease basis. These therapies preferentially kill dividing cells, but without discretion for cancer cells over normal tissue. Over the past 20 years, targeted therapies have emerged, allowing treatment of cancers with specific mutations with drugs that directly tar- get those mutations. However, the approvals of these therapies were still limited to specific dis- eases. Pembrolizumab (Keytruda) has now been approved for any solid tumor with high micro- satellite instability (MSI-high) or a deficiency in a gene associated with the mismatch repair DNA repair pathway (MMR). This advancement moves the field closer to classifying and treating cancers based primarily on their molecular pro- file, rather than on their tissue of origin. AMP Somatic Variant Guidelines The numbers of genes and variants being sequenced and reported in cancers, and the exploding number of targeted therapies, has turned the interpretation of a sequencing report into a monumental task for oncologists. Further- more, the variation among laboratories report- ing results has diversified, making it difficult for physicians to quickly identify the most important findings on a report. This year, the Association for Molecular Pathology, in collaboration with the American Society of Clinical Oncology, the College of American Pathologists, and the Amer- ican College of Medical Genetics and Genomics published guidelines for the interpretation and reporting of somatic variants. The publication laid out a tier-based system for reporting vari- ants, based on well-defined levels of clinical evi- dence. Adherence to these guidelines will help to standardize somatic sequencing reports, enhanc- ing the ability of the physician to interpret the report and ultimately improving patient care. SHERYL ELKIN Chief Scientific Officer N-of-One From Immunotherapy to Developments in Gene Editing, Experts in the Field Weigh in on the Year's Most Important Advances 2017 Year In Review Natali_Mis / Getty Images

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