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Mayo Clinic Awarded FDA Grant for Biomarker Development

Rochester, MN, USA—Resoundant, Inc. announced that the Food and Drug Administration (FDA) has awarded Mayo Clinic $250,000 to further advance liver stiffness as measured by magnetic resonance elastography (MRE) as a key biomarker for clinical trials into non-alcoholic steatohepatitis (NASH).


The grant, entitled Systematic Analysis and Threshold Synthesis for |G*| as a Diagnostic Biomarker for NAFLD and NASH Clinical Trials, will leverage the large, published evidence base for MRE to identify quantitative thresholds that are suitable for use in NASH clinical trials where staging fibrosis is needed.


“Clinical research to address chronic liver diseases, such as NASH and non-alcoholic fatty liver disease (NAFLD), has accelerated tremendously,” said Kay Pepin, PhD, senior engineer in Mayo Clinic’s lab for Advanced MRI. Dr. Pepin also services as Director of Research Translation at Resoundant, a Mayo Clinic company.


“We felt that by working with the FDA on the harmonization of cutoffs specific for fibrotic NAFLD/NASH would help move this important research forward.”


Mayo Clinic and Resoundant have been increasingly involved in providing expertise and core lab services for high-profile clinical trials, focusing primarily on MRE and proton density fat fraction (PDFF) for NAFLD and NASH trials. Both MRE and PDFF are recognized as well-validated, best-in-class MRI technologies for assessing liver fibrosis and steatosis respectively. These non-invasive technologies are routinely deployed in trials as key biomarkers due to their rapid acquisition protocols, superior accuracy, repeatability, and wide availability.


Liver stiffness via MRE as a biomarker has an accepted Letter of Intent into the FDA’s Biomarker Qualification Program – in applications from Resoundant and from the Foundation for the National Institutes of Health Biomarkers Consortium.


“There has been a welcome push by key stakeholders, patient groups, and regulatory agencies into developing noninvasive diagnostics for NAFLD and NASH clinical trials. Getting noninvasive biomarkers like liver stiffness and fat fraction quantification accepted by the FDA will be a big help to both researchers and patients waiting for novel treatments while hopefully one day replacing liver biopsy,” said Dr. Pepin.


To learn more about Resoundant’s Clinical Trial Services, visit: www.resoundant.com/clinical-trials or email clinicaltrials@resoundant.com



About MR Imaging for Chronic Liver Disease

Quantitative imaging technologies offer powerful capabilities to address the global problem of chronic liver disease. For many patients, MRE can serve as a reliable, less expensive, and safer alternative to biopsy to diagnose and stage liver fibrosis.


The technical advantages of MRE for assessing fibrosis and PDFF for assessing liver fat have been well-validated in dozens of studies against paired biopsies, with high degrees of inter-reader agreement and repeatability. Both biomarkers have also been standardized across various vendor platforms and field strengths and utilize the same quantitative cutoffs regardless of the underlying etiology (viral hepatitis, fatty liver disease, etc.) – making them ideal for clinical research. Neither is significantly affected by common co-morbidities that can cause failure in complementary ultrasound-based techniques, such as obesity.


About MRE

MR Elastography was invented at Mayo Clinic. It is widely available to clinicians at over 1,800 locations across the globe and is the only MRI technology that has been validated for staging liver fibrosis. Clinicians and patients can find U.S. locations at MRE:connect (www.resoundant.com/mre-connect). The role of MRE has been increasingly recognized in multidisciplinary clinical guidelines for routine liver fibrosis assessment, particularly in suspected cases of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The American College of Radiology issued Appropriateness Criteria® that identify MRE as the most accurate and applicable noninvasive liver fibrosis exam. MRE is reimbursed via a Category I CPT® code (76391) and is covered by numerous public and private insurance plans.


About Resoundant, Inc.

Resoundant, Inc. is a medical technology company dedicated to improving patient care and diagnosis accuracy by making Magnetic Resonance Elastography (MRE) available around the world. Resoundant is based in Rochester, MN and was founded by Mayo Foundation for Medical Education & Research, Mayo Clinic physicians and researchers.

For more information, go to http://www.resoundant.com


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