Finding patients who qualify for a clinical trial has always been one of the hardest parts of running one. In liver disease, particularly MASLD, it is especially challenging. With more than 130 active studies competing for the same patient population, screen failure rates are high and recruitment timelines are long. Most approaches rely on standard blood tests that were not designed for population-level screening.
New data from the LiveWell study, announced as a late-breaking abstract at EASL this week, suggests there is a better way.
The study, sponsored by Sano Genetics and funded by Innovate UK, evaluated a longitudinal measure called CLDI (Cumulative Liver Damage Index), derived from routine blood test data already held in NHS systems. The results, presented at the EASL Congress in Barcelona, show that CLDI identifies clinically significant liver fibrosis with an AUC of 0.884, compared to 0.572 for FIB-4, the current standard first-line investigation.
That improvement in accuracy has direct implications for clinical trial recruitment. More precise identification at the population level means better-matched patients, fewer unnecessary referrals, and a faster route from identification to eligibility confirmation. The study also demonstrated that this is operationally feasible: 994 participants were recruited from a single NHS site in under a year.
For sponsors running liver disease programs, this is worth paying attention to. Sano contributed genetic profiling to the study as part of a broader precision recruitment model linking population-level risk stratification to timely, non-invasive assessment.
The full press release follows below.
New data demonstrates highly effective way to identify clinically significant liver disease in the general population.
27 May 2026, Somerset, UK and Barcelona, Spain: Predictive Health Intelligence today announced results from the LiveWell study at the EASL Congress, demonstrating that hepatoSIGHT CLDI is a highly effective method for identifying people with clinically significant liver fibrosis from the general population using routinely collected NHS laboratory data.
The study, sponsored by Sano Genetics and funded by Innovate UK, shows that the Cumulative Liver Damage Index (CLDI) can identify clinically significant fibrosis more accurately than commonly used first-line investigations. This will enable a major shift in how liver disease is identified and managed within NHS pathways.
Chronic liver disease represents a growing challenge for the NHS. Death rates have increased more than fourfold since the 1970s, in contrast to improvements seen in many other chronic conditions. Liver disease is typically progressive and asymptomatic until advanced stages, meaning patients are often identified too late for effective intervention. Despite this, there is no national screening programme, in part because existing approaches have not been sufficiently accurate or cost-effective at scale.
Once there is a suspicion of liver disease, the current NHS pathway typically relies on a two-step approach. A first-line score such as FIB-4 is used to identify patients at risk, followed by more expensive second-line testing with Enhanced Liver Fibrosis (ELF) or transient elastography. While this is more efficient than unguided referral, the performance of first-line investigations in the general population is limited, impeding effort to improve earlier identification.
The LiveWell study evaluated an alternative approach using CLDI, a longitudinal measure derived from routine blood tests. This captures cumulative liver injury over time using the hepatoSIGHT case-finding platform. Rather than relying on a single test result, CLDI reflects the total burden of liver damage built up over years.
In this study, CLDI demonstrated strong performance for identifying clinically significant fibrosis amongst the general population, achieving an AUC of 0.884. This compares favourably to published population-level performance for FIB-4 of 0.572.
"These findings are an exciting and important step forward, showing how patients can know more, sooner, and have a better chance to act before serious damage is done," said Larry R. Holden, President and CEO of the Global Liver Institute. "For patients and families, earlier identification means more opportunity, more informed choices, and more hope. This is exactly the kind of progress we need if we are going to turn the tide on chronic liver disease."
The study recruited 994 participants prospectively from a single NHS site in less than a year, providing a substantial real-world dataset and supporting the feasibility of this approach within routine clinical pathways.
Furthermore, by using CLDI to identify high-risk individuals directly from historic data, patients can be referred straight to transient elastography, effectively creating a one-step pathway from identification to diagnostic confirmation. This reduces unnecessary sequential testing and minimises burden on both patients and services. A CLDI-based pathway would be simpler and significantly cheaper than one based on sequential blood tests. During the LiveWell study, patients identified using CLDI were invited for a non-invasive liver scan through Tawazun Health's rapid access FibroScan pathway, alongside genetic profiling provided by Sano Genetics.
"This study is a meaningful step forward for people living with undiagnosed liver disease. The fact that CLDI can identify clinically significant fibrosis this accurately, using data that already exists in NHS systems, changes what earlier identification can realistically look like at scale," said Charlotte Guzzo, Chief Operating Officer of Sano Genetics. "We are proud to have supported this work and excited to see where the larger validation study takes it."
The implications extend beyond clinical care. Patient identification remains a major constraint in liver disease research, particularly in MASLD, where there are currently over 130 active studies ongoing. By enabling more accurate identification of patients at scale, CLDI has the potential to significantly accelerate recruitment, reduce screen failure rates, and improve trial efficiency.
hepatoSIGHT has received funding to extend its footprint across the South West of England, with further rollouts planned in 2027. A wider validation study of CLDI involving 8,000 patients is now in progress, with results expected later this summer.
This work was supported by Innovate UK Grant Number iUK 10073169.
ENDS.
Notes to editors
About Predictive Health Intelligence
Predictive Health Intelligence is a medical technology company with a mission to end the late diagnosis of liver disease. They have developed a case-finding search engine to help clinicians identify people who might be at risk of developing chronic liver disease using existing, historical data. Predictive Health Intelligence was initially funded by the National Institute for Health and Care Research, and is a part NHS-owned entity.
About Sano Genetics
Sano Genetics' mission is to accelerate the world's transition to precision medicine. Sano simplifies precision medicine studies with a 360 degree platform that connects every stage: strategy consultation, patient finding, biomarker screening, patient engagement and analytics. The company works with pharmaceutical companies and biotechs to find, screen, and engage participants faster and more cost effectively. Headquartered in Cambridge, UK. More information at sanogenetics.com.
About Somerset NHS Foundation Trust
Somerset NHS Foundation Trust runs acute hospital services, community services, mental health and learning disability services and a quarter of Somerset's GP practices. Services are delivered from Musgrove Park Hospital in Taunton, Yeovil Hospital, 13 community hospitals, and a range of mental health and learning disability services.
About Tawazun Health
Tawazun Health is a CQC-regulated specialist provider of FibroScan liver assessments, delivering early identification of liver disease risk across healthcare, community, research, and corporate environments. Learn more at tawazunhealth.com.
Media contact
James Hounsell, Co-Founder, Evolene Ltd. James.hounsell@evolene.co.uk