Resoundant Expands Services Offerings to Support Use of Quantitative Imaging Biomarkers in Clinical Trials
Resoundant, Inc. announced today that the company is expanding its clinical research services in collaboration with the scientists and medical professionals at Mayo Clinic.
In recent years, clinical research to address chronic liver diseases, such as non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD), has accelerated tremendously. Resoundant has been increasingly involved in advising and providing core lab services for numerous high-profile Phase IIa and Phase IIb trials in these areas.
In response to this growing global demand, Resoundant has made significant investments to expand its suite of clinical research services. These new services include access to Resoundant/Mayo Clinic analysts for central image reads, secure data management, quantitative reporting, site training and identification, regulatory support, study start-up/close-out support, quality control, and proprietary in-house analytics.
Resoundant has focused primarily on two technologies that have become widely applied in clinical trials focused on liver disease: Magnetic Resonance Elastography (MRE) and imaging of proton density fat fraction (PDFF). 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.
“These imaging-based biomarkers are powerful tools in clinical trials and in clinical management of liver disease,” said Richard Ehman, MD, professor of radiology and the Blanche R. & Richard J. Erlanger Professor of Medical Research at Mayo Clinic, and Chief Executive Officer of Resoundant.
“We’re extremely fortunate to be able to tap the expertise and technical know-how of the team that pioneered the development and translation of MRE at Mayo Clinic. Our continuing goals are to help move these projects forward at a lower cost and with greater technical capacity than ever before.”
Since 2017, Resoundant and Mayo Clinic staff have consulted or served as a core laboratory on nearly a dozen trials in the liver disease arena, providing analysis services for thousands of MRE and PDFF exams for indications such as NAFLD, NASH, hepatitis C, hepatitis B, and primary biliary cholangitis.
“This is a very natural expansion for our company,” said Kathy Anderson, JD, Chief Operating Officer of Resoundant. “Our close connections with Mayo Clinic, as well as with talented contract research organizations across the globe, has resulted in sustained organic growth for our clinical trial services.”
To learn more about Resoundant’s Clinical Trial Services, visit: http://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 1,500 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 (http://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
Mayo Clinic and Dr. Ehman have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.
