The collaboration aims to broaden clinical access to non-invasive diagnostics like the ELF blood test to detect liver disease before serious complications develop.
Siemens Healthineers and Novo have announced a collaboration focused on advancing care for patients living with metabolic dysfunction-associated steatotic liver disease (MASLD) and its progressive form, metabolic dysfunction-associated steatohepatitis (MASH). The organizations are engaged in several initiatives to strengthen disease awareness, support earlier clinical assessment, and expand patient access to non-invasive blood testing.
According to the companies, MASLD affects millions of people worldwide, including nearly a quarter of US adults, and is closely associated with obesity, type 2 diabetes, and cardiovascular disease. Furthermore, the announcement noted that MASLD has become the leading indication for liver transplant among women, with healthcare costs associated with the condition projected to exceed $635 billion by the end of the decade. Although the condition is reversible if detected early, silent progression and low disease awareness have left many individuals undiagnosed until significant liver damage develops.
“Too often, liver health flies under the radar,” says Michele Zwickl, head of laboratory solutions for Siemens Healthineers North America, in a release. “People deserve the same level of awareness as for other major diseases, creating a better opportunity to intervene before serious complications develop.”
Expanding Access to Non-Invasive Testing
Historically, clinical assessment of liver fibrosis has relied heavily on specialized imaging equipment or invasive procedures such as liver biopsy, which are not widely accessible to patients, according to the release. While clinicians recognize that liver biopsy remains necessary for certain individuals, consensus has grown around the role non-invasive tests play in the broader management of MASLD and MASH.
The collaboration seeks to advance solutions that make disease assessment more accessible across the healthcare continuum, including increasing the adoption of non-invasive testing approaches to provide diagnostic insights while reducing reliance on invasive biopsies.
Among these diagnostic options is the Enhanced Liver Fibrosis (ELF) test from Siemens Healthineers, which is the first and only blood test authorized in the US to help clinicians assess the risk of disease progression in patients with advanced fibrosis due to MASH and guide patient management decisions, according to the companies. The test is available through major national laboratory providers and covered by Category 1 CPT code 81517. In addition to supporting high patient testing volumes, blood-based testing avoids failure rates and unreliable results associated with certain other non-invasive modalities; for example, ELF test results are not impacted by patient body composition characteristics such as BMI.
“Earlier triage is one of the most important opportunities to improve the future of MASH care,” says Michelle Long, senior international medical director for MASH at Novo, in a release. “Our collaboration recognizes that patients, clinicians, laboratories, health systems, and industry partners all have a role to play in creating a more effective pathway for liver disease assessment and management.”
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