Perspectum today released the results of a multinational study showing that LiverMultiScan can reduce liver biopsies, lead to fewer specialist consultations, and improve the rate of diagnosis for patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The groundbreaking study was published in Nature Communications Medicine and shows that MRI for patients with MASLD is cost-effective in Europe.
"These findings support the utility of multiparametric MRI biomarkers to diagnose and improve patient management all while avoiding the need for biopsy in many patients," said Perspectum CEO, Rajarshi Banerjee, MD, PhD. "Specifically, the study showed Perspectum's LiverMultiScan improves certainty of diagnosis to allow for timely treatment, lowers costs and helps clinicians and patients to manage symptoms and reduce the impact of the disease."
In this real-world, randomized control study, 802 adults with suspected MASLD from four countries were diagnosed with either LiverMultiScan or usual care which included ultrasound and liver biopsies. The study reflected the real-life clinical practice of providers in each of the countries, and the participants were monitored for up to one year. To measure cost-effectiveness, the authors compared access to health care practitioners, patient assessments, and number of patients with a diagnosis at the end of the trial. Liver fat (PDFF) and disease activity (cT1) were used to identify patients not requiring biopsy in the imaging arm.
Key findings of the RADIcAL-1 study showed:
- The use of non-invasive multiparametric MR images (LiverMultiScan) is a cost-effective tool that achieved an Incremental Cost-Effectiveness Ratio (ICER) per Quality-Adjusted Life Year (QALY) gained of €4,929 (USD$ 5,369).
- Diagnosis rates were improved by approximately 10 percent compared to the current standard-of-care.
- The need for specialist consultations were reduced including 7 percent fewer hospital appointments, 7 percent fewer visits to general practitioners, and 29 percent fewer ultrasound procedures.
- Importantly, the study avoids 50 percent of unnecessary biopsies, offering a safer, pain-free alternative without increasing liver-related health care use.
The economic burden of chronic liver diseases is rising globally. MASLD affects approximately 30 percent of the population in North America and Europe. The cost of managing MASLD is significant, with direct annual medical costs estimated at $103 billion in the U.S. and €27 billion in Europe.1 With the introduction of the first ever drugs to treat metabolic dysfunction-associated steatohepatitis (MASH), such as Rezdiffra (resmetirom), an alternative to liver biopsy is essential. Liver biopsy is an invasive diagnostic involving significant health risks and discomfort, including a 2.4 percent risk of significant complications. The new study results illuminate the clinical performance of multiparametric MRI when used to identify and monitor patients prescribed the new classes of MASLD therapeutics.
"In addition to being more patient friendly and faster, this study shows non-invasive pathways are more cost-effective than liver biopsy. The evidence in the study may also provide policy makers and practitioners with a greater understanding of how scaling LiverMultiScan into standard of care can be a win-win for improving diagnosis and managing costs associated with care," said Dr. Banerjee. "The RADIcAL-1 study points to the promise of multiparametric MRI as a cost-effective tool to identify and manage MASLD patients with fewer specialist appointments and interventions, offering patients an alternative to biopsy."
Henry Chang, Executive Director of the Fatty Liver Foundation, commented, "This study demonstrates that multiparametric MRI is a cost-effective, non-invasive diagnostic tool that can enhance MASLD detection, reduce dependence on liver biopsies, and improve overall healthcare efficiency. Diagnostic innovations that streamline clinical workflows while minimizing patient burden, are essential to advancing MASLD care, particularly given the increasing prevalence of the disease."
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 719445.
About Perspectum:
Perspectum, a global medical technology company, with offices in the U.S and U.K, delivers leading digital technologies that help clinicians provide better care for patients with chronic metabolic disease, multi-organ diseases, and cancer. With a strong focus on precision medicine using advanced imaging, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, monitoring, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers, and technologists, Perspectum offers a way to manage complex health problems at scale.
About LiverMultiScan:
LiverMultiScan is a commercially available, FDA cleared software medical device (SaMD) intended for diagnosis, monitoring, and clinical management of patients with liver diseases. It is a non-invasive, non-contrast, and safe technology that assesses the liver disease activity, fat, and iron using existing MRI infrastructure and provides visually enhanced patient friendly results. Various research studies and peer reviewed publications demonstrate the clinical utility of LiverMultiScan in the diagnosis and monitoring of liver diseases such as MASH/MASLD, auto-immune hepatitis, and viral hepatitis.
About MASLD:
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a spectrum of liver diseases where there is excess fat in the liver (steatosis). MASLD is a growing global public health problem, fueled by the prevalence of obesity and related metabolic disorders. MASLD remains drastically underdiagnosed, often placing patients at risk for complications. Early diagnosis and intervention, including lifestyle modifications and pharmacological treatments, are crucial in managing MASLD and preventing serious liver complications.
1 Younossi ZM et al. The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology. 2016; 64:1577-1586. |
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Contacts:
For further information, please contact:
Sandy Max
Director of Government and Corporate Affairs
Perspectum, DC Office
sandra.max@perspectum.com
