Clinical Lab 2.0 Study to Evaluate how the ‘Lab Initiated Care Model’ Can Help Address a Leading Cause of Liver Disease

Clinical Lab 2.0, a Project Santa Fe Foundation initiative, has received a grant from Siemens Healthineers to demonstrate how clinical laboratories can support identification of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) and improve care for patients at risk for advanced liver disease.  The liver disease that can result from MASLD is the number one cause of liver transplantation in women; significantly affecting men as well. [1]

MASLD is a growing health concern and thought to be the liver’s manifestation of metabolic disease and is caused by the buildup of excess fat in the liver. [2] Most people with MASLD are unaware that they have this disease, as it is typically asymptomatic and progresses silently. [3] It is fueled by comorbidities such as obesity, diabetes, and metabolic syndrome. [4] [5]

Almost one in three adults in the U.S. have MASLD. [6] [7] About 20% (approximately 1 in 5) will progress to a more aggressive form of the disease known as Metabolic dysfunction-Associated Steatohepatitis (MASH) and are at risk to develop progressive disease.  Without early intervention, outcomes could include advanced fibrosis or cirrhosis, with its related risks of liver cancer and/or liver failure. [8]

Clinical Lab 2.0 is a coalition of laboratory leaders exploring how laboratory medicine and pathology can expand the role of diagnostic services to support population health management and increasingly serve the health system through established standards and evidence.  The research coalition focuses its projects on diseases which have a high prevalence in the population.

Demonstration projects such as the MASLD study serve to develop the clinical evidence base for the valuation of clinical laboratory services in achieving better patient outcomes and cost-effective healthcare.  The Clinical Lab 2.0 demonstration project for MASLD will examine the impact of a non-invasive blood test in patients with diabetes and pre-diabetes, to better identify patients who are at risk for serious liver disease arising from MASLD.  The project goal is to evaluate how well clinical guidelines are being followed at the participating institutions, and to examine the impact of recommended screening on the health care being provided to these patients.  The evidence obtained from this study can inform improvements in patient care pathways, so that potential liver disease can be identified and managed earlier in its course.

“Clinical Lab 2.0 is an international effort to improve health care for people with chronic health conditions.  This project is significant because participation extends beyond the founding institutions to involve health systems who not only share the vision but are also participating in examining how MASLD is being managed in their patient populations.  The systems want to proactively risk stratify for earlier detection and disease management, with the goal of preventing progression of MASLD to MASH and its severe outcomes,” said Khosrow Shotorbani, MBA, MT(ASCP), the CEO and co-founder of the Project Santa Fe Foundation, founder of the Clinical Lab 2.0 movement.  “The aim of Clinical Lab 2.0 is to help improve human condition”, said Dr. James Crawford, MD, PhD, chair of the board of directors for Project Santa Fe Foundation, and emeritus chair of pathology at Northwell Health.  “The patient populations that will be studied at the three participating institutions are diverse, with varying degrees of access to medical resources, and spanning rural and urban settings in different regions of the U.S.  The project will allow us to develop and share a model which other laboratories can use to help their health system provide earlier care for MASLD patients.”  Three integrated health systems will support the project, including Boston Medical Center (Boston, Mass.), Northwell Health (New Hyde Park, N.Y.) and Advocate Health (Charlotte, N.C.) which is affiliated with Wake Forest University.  Siemens Healthineers, the sole grant provider for the project, is a participating corporate member of Clinical Lab 2.0.

Clinical Lab 2.0 projects turn potential into real-world clinical application and benefit,” said Michele Zwickl, head of Laboratory Solutions, Siemens Healthineers North America.  “Siemens Healthineers is invested to fostering collaborative innovation that underscores the clinical laboratory’s value to a health system.

1. Noureddin et al. 2018. Am J Gastroenterol. 113(11):1649–59.
2. Kim CH et al. 2008. Cleve Clin J Med. 75(10):721-728.
3. Alqahtani et al. 2021. Hepatol Commun. 5(11)1833-1847.
4. Younossi et al. 2018. Nat Rev Gastroenterol Hepatol. (15)11-20.
5. Tinaro et al. 2021. Endocrinol Metab Clin North Am. 50(3):37-55.
6. Lee et al 2024. Hepatology. 79 (3): p 666-673.
7. Ciardullo S et al. 2021. Liver Int. 41(6):1290–3.
8. Cusi, K et al.2022. Endocrine Practice. (28) 528-562.