Clinical OMICs - Volume 3, Issue 9 - 32

Biomarkers Market (continued from page 5) about 40%, in 2015 due to increased routine healthcare checkups and the growing base of the geriatric population, which is at a high risk of developing a host of diseases. The validation biomarkers segment is one of the fastest growing market segments. Increasing R&D initiatives to develop more specific biomarkers, and the subsequent development of companion diagnostics with enhanced accuracy and sensitivity are key factors in this growth. Biomarkers used by pharmaceutical companies to accelerate the develop of new drugs and as predictive tools in whether a drug will fail helped drug discovery dominated the application segment in 2015. The diagnostic segment will experience significant growth due to the increasing awareness of routine healthcare checkups and rising prevalence of various diseases. In 2015, the oncology segment dominated revenue generation at more than $9.2 billion due to increases in the number of diagnostic tests for oncology drugs and the increasing burden of cancer around the world. The cardiovascular segment is expected to experience the fastest growth over the forecast period, at more than 14%, a result of increasingly sedentary lifestyles and obesity. North America held the largest regional share of the market, around 39% in 2015, while Asia Pacific is anticipated to be the fastest growing biomarker market owing to factors such as the developing economic conditions, a large base of the target population, and a favorable regulatory scenario for clinical trials. New Markers (continued from page 7) Integrating this capability to measure TMB and MSI with one tissue sample, and reported in one test, represents an important advance in clinical care." TMB is described as the total number of DNA mutations per megabase in a tumor sequence. The use of TMB scoring has been gaining favor as a predictor of the likelihood of patients to respond to cancer immunotherapy treatments. Three separate abstracts presented at the American Society of Clinical Oncology (ASCO) annual meeting earlier this year focused on TMB as a possible predictor of immunotherapy response in non-small cell lung cancer, melanoma, and urothelial carcinoma, with each showing correlation between measured TMB and immunotherapy treatments. 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. Some tumors develop high TMB as a result of defective mismatch repair of DNA, a condition in which the length of certain DNA areas becomes more widely varied than normal. This condition, which is referred to as MSI-high and MSI-high tumors, almost always has a high TMB. "The ability to accurately measure multiple biomarkers simultaneously, including TMB and MSI, is an important advance for the field of cancer immunotherapy," said Thomas George, M.D., GI oncology program director, University of Florida. Clinical Utility Standard Significantly, AMP takes issue with the Medical Test Methods Guide from Agency for Healthcare Research and Quality (AHRQ), which asserts that "the value of a medical test must always be linked to the context of use, including molecular diagnostics." From AMP's point of view, the use and value-the clinical utility-of MDx to help inform patient care is not nearly as narrow as the AHRQ contends. Instead it seeks a broader context for the CU of MDx as a vital tool in a medical team's global patient assessment and management, a role of increasing importance as the U.S. health system shifts to value-based, patient-centered care. (continued from page 5) ular diagnostic testing based upon realistic evidence levels is paramount and clinical utilities beyond therapeutic selection are valuable to patients, providers, and family members," said Elaine Lyon, Ph.D., 2014 AMP president and FEND Task Force co-chair. "Ultimately, we need to capture evidence for the clinical utility of molecular pathology procedures outside of a traditional randomized control trial setting, recognizing that any individual test result is an intermediate outcome that relies on proper clinical interpretation and utilization in context for that specific patient to achieve maximum benefit." 32 Clinical OMICs September 2016 www.clinicalomics.com http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9