Frequently asked questions

LiverPRO is a data-driven and evidence-based Software as a Medical Device (SaMD) that timely and accurately detects liver fibrosis. It combines age with data from minimum three out of nine common blood-based biomarkers to produce an easily interpretable liver fibrosis risk score and category. Typically, patients are grouped into low, moderate, and high risk. In some use cases, the risk score and category are coupled with a clinical recommendation on next steps.  

LiverPRO is based on a static machine-learning model that does not continuously learn during use. It is developed and provided by Evido Health to challenge unsustainable patient pathways in clinical practice and trials, unlocking a preventive healthcare system where early diagnosis and interventions with tailored treatments are the norm.

LiverPRO is designed for standard and routine laboratory parameters such as liver enzymes and markers of liver functions (i.e. excretion, metabolism, portal hypertension, and synthesis). It combines age with data from minimum three out of nine common blood-based biomarkers, namely, albumin, alkaline phosphatase (ALP), aspartate transaminase (AST), bilirubin, cholesterol, gamma-glutamyl transferase (GGT), international normalised ratio (INR), platelet count, and/or sodium. Due to its inherent flexibility, LiverPRO adapts to whichever three or more biomarkers that are available per individual. The only mandatory input variable is age.

LiverPRO automatically selects the best-performing combination of input variables that is available. The optimal combination depends on the targeted liver fibrosis stage(s). In general, including more input variables can (but does not necessarily) lead to higher performance. If available input variables are predictive of a certain liver fibrosis stage, three variables can yield the same performance as nine input variables.

No. LiverPRO is a fully digital solution (Software as a Medical Device, SaMD) that uses and processes information about age combined with standard and routine data from already sampled blood tests.

By combining age with data from minimum three out of nine common blood-based biomarkers, LiverPRO can be applied to:

• Individual patient laboratory panels in clinical care
• Historical laboratory data in electronic health records (EHR)
• Aggregated laboratory datasets in real-world evidence or clinical trial databases

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As long as the required input variables are available in structured form, LiverPRO can be run retrospectively or prospectively.

LiverPRO is directly compatible with existing clinical workflows, leveraging blood test results that have already been sampled during consultations with at-risk patients. LiverPRO is integrated centrally in the laboratory information systems (LIS) to provide automated processing once the input variables are ordered and measured, which means that no additional actions are required by the clinicians. The results (risk score, risk category, and clinical recommendation) are then delivered as part of the laboratory report in the electronic health record (EHR) system.

LiverPRO can be used as a screening tool in steatotic liver disease (SLD) clinical trials to identify patients with a higher probability of meeting liver fibrosis inclusion criteria before undergoing more invasive or costly tests. By enriching the pool with candidates more likely to be eligible, sites can recruit faster and with fewer procedures.

During clinical trials, LiverPRO can be applied in two main ways: as a centralised screening solution or as a pre-screening tool.

• In the use case of a centralised screening solution, a sponsor/CRO runs LiverPRO on blood test results to identify candidates that should move to confirmative testing. This helps increase correct classification rate of the entire screening pathway and reduce screen failure rate while testing less individuals overall.
• In the case of a pre-screening tool, individual sites use LiverPRO directly on their own candidate lists, referrals, or internal databases. Site staff upload existing routine laboratory data, receive LiverPRO risk scores for each candidate, and invite high-risk patients for formal screening. This uncovers eligible patients from data sources that have not been previously used or have been used but in an inefficient manner, allowing sites to find more patients for clinical trials faster.

LiverPRO can be applied to real-world patient datasets across several use cases, bringing an opportunity to enrich existing data with regulatory-grade liver fibrosis score. Because it runs on routine laboratory data already present in many databases (e.g. patient registries, EHRs, and insurance claims), LiverPRO can be deployed retrospectively without additional sampling or physical procedures.

Specific applications include but are not restricted to: prevalence mapping of liver fibrosis, predicting liver-related events such as liver-related death or complications, and tracking LiverPRO score changes over time in longitudinal data, with or without a therapeutic intervention.

LiverPRO insights can support evidence portfolios for trial design, HTA submissions, market launch preparations, patient awareness campaigns, and more.

LiverPRO has been validated across multiple patient cohorts with various disease prevalence, risk factors, ethnicities, and steatotic liver disease (SLD) conditions. It has been tested in real-world patient data sources and clinical trial cohorts using retrospective and prospective analysis methods. The scientific publication describing the development, validation, and prognostic evaluation of LiverPRO was published in The Lancet Gastroenterology and Hepatology (Lindvig, K. P., et al., 2025).

LiverPRO is a CE-certified medical device according to the In Vitro Diagnostic Regulation (IVDR Class B), allowing clinical implementation across Europe. Its intended use is to assess the likelihood of having liver fibrosis among adult individuals at risk of steatotic liver disease (SLD). In other words, LiverPRO is authorised as a diagnostic support tool in Europe.

Outside Europe, the CE-mark is widely accepted in many markets. Otherwise, LiverPRO may be used in research or under local regulatory frameworks as appropriate.