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( FMI ) today announced the addition of new clinical markers to its FoundationOne and FoundationOne Heme products, which are designed to enhance oncologists insight into potential response to immunotherapies. This ability to determine TMB and MSI from its assays is additional to the existing comprehensive profiling of genes provided by FoundationOne and FoundationOne Heme. Taken together, the molecular information provided by Foundation Medicine provides unique insights to physicians and enhances their ability to predict response to immunotherapies, identify targeted therapeutic options, and improve access to clinical trials all from a single assay. Cancer immunotherapies are at the forefront of cancer treatment, and new, quantitative approaches are needed to predict clinical responses to this important, but also expensive, class of therapies, said Vincent Miller, M.D., chief medical officer of Foundation Medicine. Prior to our ability to measure TMB and MSI with FoundationOne, these biomarkers could only be detected separately, either through tests such as immunohistochemistry, polymerase chain reaction (PCR) or whole exome sequencing. Importantly, high-quality, predictive TMB scoring can only be accurately performed with sophisticated algorithms developed to work with broad, hybrid capture-based platforms that can analyze all relevant alterations simultaneously. Integrating this capability to measure TMB and MSI with one tissue sample, and reported in one test, represents an important advance in clinical care. A growing body of evidence, most recently presented at the American Society of Clinical Oncology (ASCO) annual meeting this year, validates the ability of a new independent marker, TMB, to predict the likelihood of response to cancer immunotherapies. TMB is reported as the total number of DNA mutations per megabase in a tumor sequence. This phenomenon has been validated across a wide range of tumor types, including advanced bladder cancer, lung cancer, breast cancer, colorectal cancer, advanced head and neck cancer and melanoma.
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