AMRA and BioTelemetry Research Raise the Standard for Medical Imaging in NASH/NAFLD Clinical Trials
AMRA, the international leader in body composition analysis, and BioTelemetry Research (“BTR”), a leading global imaging and cardiac core lab, announced today the formation of an exclusive alliance for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) clinical trials. This first-to-market partnership will advance imaging science and benefit clinical trial sponsors in several musculoskeletal and metabolic therapeutic areas.
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In clinical studies, muscle and fat fractions have traditionally been measured by scanning individual organs such as the liver, or particular body regions such as the abdomen. Commonly, researchers would prefer to scan the entire body in order to learn exactly where study participants are losing or gaining muscle or fat mass. However, until now they have been constrained by prohibitive costs and insufficiently precise outcomes.
AMRA’s body composition analysis service has introduced a new and better paradigm where rapid, six-minute whole body MRI scans are transformed into precise, three dimensional-volumetric fat and muscle measurements. This standardized, automated method eliminates reader variability and reduces processing costs. With those advancements, BioTelemetry Research is able to provide clinical trial sponsors with new, high-value information to about their drug compounds’ efficacy and mechanisms of action, including the identification of previously undetectable changes within and beyond the liver.
Tommy Johansson, Chief Executive Officer of AMRA, commented, “BioTelemetry Research is the ideal core lab to help us deliver this enhanced value to clinical trial sponsors. They bring unique expertise managing the protocol complexity, site training intensity and equipment variability that are common to non-standard-of-care MRI trials.” He continued, “BioTelemetry was a leading pioneer in proton density fat fraction (PDFF) analysis, and have analysed more liver fat cases, from more sites, in more regions than any other group in industry. I am excited to see where our partnership will take us.”
BioTelemetry Research President and General Manager, Scott Satin, added, “By employing AMRA’s automated analysis, we are now able to efficiently provide more actionable data to our pharmaceutical partners. Ordinarily, a whole body MRI scan takes 10 to 15 minutes and produces hundreds of images. Prior to AMRA, such analyses were infeasible in clinical trials largely because of the time needed to label fat and muscle tissues within every image. With those challenges eliminated, we can now help sponsors assess the effects of their treatments more quickly and completely.”
Through collaboration with leading universities such as the University of California, San Diego (UCSD) and the University of Westminster, London, AMRA’s technique has been proven to enable market-leading accuracy and precision when measuring fat depots and muscle volumes, as well as the fat infiltration of muscles and in organs. BioTelemetry has the scientific expertise and operational experience to apply this technique successfully in global clinical trials. Together, the alliance is committed to accelerate the prevention and treatment of diseases such as NAFLD and obesity.
AMRA is the first in the world to transform images from a rapid, 6-minute whole body MRI scan into precise, 3D-volumetric fat and muscle measurements. AMRA’s cloud-based analysis service offers precise, automated insights that have far-reaching implications for the pharmaceutical industry, academic R&D and, soon, clinical practice. AMRA was founded in 2010 as a spin-off of the Center for Medical Image Science and Visualization (CMIV), the Department of Biomedical Engineering (IMT) and the Department of Medicine and Health (IMH) at Linköping University, Sweden. For more information, visit www.amra.se.
BioTelemetry Research is the clinical research division of BioTelemetry, Inc., (NASDAQ: BEAT) the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care. The Company currently provides cardiac monitoring services, original equipment manufacturing with a primary focus on cardiac monitoring devices and centralized imaging and cardiac core laboratory services. More information can be found at www.gobio.com/research.
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