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Overview

Clinical algorithms that support your practice in triaging patients with suspected MASLD and assessing fibrosis severity

Metabolic dysfunction-associated steatotic liver disease, MASLD, is the leading cause of liver-related morbidity and mortality,³ affecting nearly 1 in every 3 people.⁴ Diagnosis of advanced fibrosis due to MASLD remains a challenge due to its silent progression and vast prevalence, with over two-thirds of cases undiagnosed.⁵

As MASLD progresses, it may lead to metabolic dysfunction-associated steatohepatitis, MASH. Approximately 20% of patients with MASH with advanced fibrosis or compensated cirrhosis will progress to cirrhosis or develop decompensation, respectively, over a 2-year time period.⁶

navify algorithms, FIB-4 Index and ADAPT by Evidencio are clinical algorithms that assess the likelihood of advanced liver fibrosis and fibrosis severity in patients showing evidence or signs of MASLD.

Global prevalence is 38% and rising⁴

The prevalence of MASLD will be increasing parallel to the prevalence of metabolic diseases.⁷

90% of patients are undiagnosed⁸

MASLD is frequently asymptomatic in its early stages, allowing silent progression to more severe conditions.⁹

~€35 billion in annual medical costs¹⁰

The economic burden of MASLD is substantial and escalates notably with disease progression.¹¹

Liver fibrosis can be reversible, if caught early enough¹²

FIB-4 Index is a CE-marked Class C IVD* non-invasive risk stratification tool intended to be used by healthcare professionals as the first-line step in assessing the likelihood of advanced liver fibrosis (stage F3-F4). It is intended for use in adults suspected of MASLD to triage patients into low, Intermediate or high likelihood and therefore at-risk categories.¹

ADAPT is a CE-marked Class C IVD** algorithm intended to combine age, diabetes status, Elecsys® PRO-C3 concentration and platelet count to assess the severity of hepatic fibrosis in patients showing evidence or signs of MASLD.²

Non-invasive tests

Rely on blood-based biomarkers: AST, ALT, platelet count for FIB-4 Index¹ and Elecsys® PRO-C3, and platelet count for ADAPT.²

High sensitivity and specificity

Combining high sensitivity of 1st line assessment, FIB-4 Index, with the high specificity of 2nd line assessment, ADAPT.¹³

In line with MASLD guidelines

ADAPT shows relative high performance in identifying MASLD with advanced fibrosis in tertiary hepatology care and in ruling out advanced fibrosis in low-risk populations.¹⁴

FIB-4 Index score interpretation. FIB-4 Index score less than 1.3 (age 65 or younger) or less than 2.0 (over 65 years): low likelihood of advanced fibrosis (F3–F4). Score 1.3 to 2.67 (age 65 or younger) or 2.0 to 2.67 (over 65 years): intermediate likelihood of advanced fibrosis (F3–F4). Score greater than 2.67: high likelihood of advanced fibrosis (F3–F4). Interpreting the score of FIB-4 Index: a numeric score interpreted based on cut-off values indicating different likelihoods of advanced liver fibrosis; note that results apply to MASLD population.

Interpreting the score of FIB-4 Index

The FIB-4 Index outcome is a numeric score that can be interpreted, based on cut-off values, as different likelihoods of having advanced liver fibrosis.¹^,¹⁴

NOTE: results applicable for MASLD population.

Interpreting the score of ADAPT

ADAPT's scoring system provides specific cutoffs for different stages of fibrosis, allowing clinicians to assess the severity of hepatic fibrosis in patients with significant fibrosis (≥F2), advanced fibrosis (≥F3) or cirrhosis (F4) and no intermediate zone.²^,¹³

Benefits

Supporting patient throughput in MASLD assessment

Regulated FIB-4 Index and ADAPT algorithms, directly integrated into your workflow, could improve clinical decision-making, including potential streamlining of workflows, lower testing impact on healthcare budget, regulatory compliance and patient safety.

Streamlining patient throughput

ADAPT potentially reduces false positives, ensuring significant fibrosis patients are genuinely at risk.¹³

Reduce testing costs

Testing specificity is identified as the primary driver of potential savings, which ADAPT could contribute to.¹⁵

Legal and regulatory certainty

CE-mark ensures compliance for the use of formulas in the EU for a clinical purpose.¹⁶^,¹⁷

Assurance of quality and cybersecurity

Evidencio products developed and validated under processes that comply with international standards (ISO 13485:2016; ISO 27001:2022).¹⁸^,¹⁹

Integration

Integration via navify Algorithm Suite

Experience a single integrated platform designed for healthcare providers and laboratories that simplifies IT complexity while reducing the risk of vulnerabilities. With integrated Roche and partner medical algorithms, we provide a comprehensive solution that streamlines processes and enhances collaboration.

Integration workflow step by step²⁰

1) In the EMR, an order for the ADAPT is dispatched/ordered via Order Entry by HCP.

2) The order for Platelets, PRO-C3 (and others, as ordered) are transmitted to the devices; the results are being determined.

3) Results are transmitted from the device to the LIS.

4a) The request is sent to navify® Integrator via HL7 from the LIS.

4b) Certain input parameters, such as Diabetes Status, may only be provided by the EMR; this can be sent directly to navify Integrator via the Interoperability Engine for navify Integrator.

5) The request is transformed into a request that is standardized and sent to navify Algorithm Suite.

6) After computing ADAPT, the result is returned.

7) After receiving the result, it is returned to the LIS.

8) ADAPT score and interpretation is returned to EMR via the existing workflow.

Single point of contact for customer support

Roche offers centralized customer support for all algorithms in our portfolio to ensure consistency and reliability. We manage issues that arise for all hosted algorithms, streamlining the process and eliminating the need for customers to engage with individual providers.

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Security and data privacy are central to Roche's operations, founded on a "Security and Privacy by Design" philosophy and ISO/IEC 27001 certification. Our dedicated technical team performs ongoing risk assessments, penetration tests and network monitoring to minimize IT complexity and vulnerabilities, prioritizing data confidentiality to protect patient information across all partners.

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FAQs

Frequently asked questions

If you don’t find answers to your questions here, we’re happy to provide more information and discuss your needs in detail.

For whom is the FIB-4 Index intended?

The FIB-4 Index algorithm is intended for use in patients who meet the indications and contraindications listed below¹:

Clinical Indications

The FIB-4 Index should be used for patients who meet the following inclusion criteria:

Adults (≥18 years of age)
Patients with suspected or established chronic liver disease due to one or more of the following etiologies:
- Metabolic dysfunction-associated steatotic liver disease (MASLD), including metabolic dysfunction-associated steatohepatitis (MASH)
- Chronic hepatitis C (HCV)

Clinical contra-indications

The FIB-4 Index should not be used for patients who meet the following exclusion criteria¹:

Patients with hepatocellular carcinoma (HCC)

Although not considered exclusion criteria, the results of the FIB-4 Index should be reviewed with extra attention if the patient meets one or more of the following:

Haemochromatosis, as there is limited data on this condition in the context of risk prediction algorithms, including the FIB-4 Index
Sustained virologic response (SVR) in HCV patients
In chronic hepatitis B (HBV), standard FIB-4 cut-offs may misclassify fibrosis stage (reported in the EASL clinical practice guideline on the management of HBV infection, based on the SONIC-B study)

For whom is the ADAPT algorithm intended?

The ADAPT algorithm is intended for use in patients who meet the indications and contraindications listed below²:

Clinical indications

The ADAPT algorithm should be used for patients who meet the following inclusion criteria:

Patients should be at least 18 years of age
Patients should be referred for investigation due to abnormal biochemical tests (e.g., abnormal alanine aminotransferase [ALT] or γ-glutamyltransferase [GGT] levels, or FIB-4 Index score) or an ultrasonographically detected bright liver associated with features of metabolic syndrome
Patients should show signs or evidence of metabolic dysfunction-associated steatotic liver disease (MASLD)

Clinical contraindications

The ADAPT algorithm should not be used for patients who meet the following exclusion criteria:

Patients in a primary care population without prior confirmatory tests (see inclusion criteria)
Patients with other chronic liver diseases, including hepatitis B or C, or patients with excessive alcohol consumption

How do the FIB-4 Index and ADAPT benefit my practice?

The FIB-4 Index is designed to assist in assessing patients based on relevant clinical outcome parameters. Specifically, it estimates the risk of advanced liver fibrosis to support clinical decision-making for patients with (potential) liver disease who are suspected or at risk of having advanced fibrosis. Correct use of the FIB-4 Index can provide the following clinical benefits¹: Assist in risk stratification for patients, and improve the speed and reliability of calculations through digital implementation of the algorithm as a medical device.
The benefits and risks associated with ADAPT for the patient are indirect. These benefits arise from clinical decisions made using ADAPT in combination with other clinical and patient-specific factors. ADAPT assists in the risk stratification of patients with (signs or evidence of) MASLD based on the severity of liver fibrosis².
Together, the FIB-4 Index and ADAPT may help reduce the number of false positives referred for further assessment.¹³

What is the difference between the public FIB-4 Index formula versus the navify® Algorithm, by Evidencio?

While the formula of both versions is the same, the difference is that the navify® algorithm is a Class C IVD (CE-marked) clinical decision support tool, fully integrated into the laboratory / clinical workflow, offering validated, guideline-specific interpretations for advanced fibrosis in patients with MASLD and HCV.

The navify algorithm, FIB-4 Index by Evidencio, allows users to select the guideline and offers a recommendation and reference in a concise manner for quick actionability by the clinician. It is available in a fully automated clinical workflow integration that delivers results directly into lab reports like a standard test, or through a semi-automated web version (navify Portal). Moreover, Roche and Evidencio handle all maintenance, updates, and compliance issues.

In contrast, publicly available FIB-4 versions are not certified and lack IVDR compliance. This poses a potential regulatory risk, even if made available from various vendors as standalone, or integrated by an LIS provider. The laboratory would then use the list of references as support for cut-offs and interpretation, and is also responsible for updates, maintenance and issue handling (unless handled by the vendor).

Can the FIB-4 Index and ADAPT be integrated into existing LIS / EHR?

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References and notes

FIB-4 Index User Manual v1.0
ADAPT User Manual v1.0
Chan WK, et al. Metabolic dysfunction-associated steatotic liver disease (MASLD): a state-of-the-art review. J Obes Metab Syndr. 2023 Sep 30;32(3):197-213. doi:10.7570/jomes23052.
Younossi ZM, et al. Clinical Molecular Hepatology. Clin Mol Hepatol. 2025 Feb;31(Suppl):S32-S50. doi:10.3350/cmh.2024.0431.
Tantu C, et al. Pathophysiology, noninvasive diagnostics, and emerging personalized treatments for metabolic associated liver diseases. npj Gut Liver. 2025 Aug, 2:18. doi:10.1038/s44355-025-00030-2.
Loomba R, Adams LA. The 20% rule of NASH progression: the natural history of advanced fibrosis and cirrhosis caused by NASH. Hepatology. 2019;70(6):1885-1888. doi:10.1002/hep.30946.
Younossi ZM, Golabi P, Price JK, et al. The global epidemiology of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis among patients with type 2 diabetes. Gastroenterology. 2024;22(10):1999-2010.e8.
Stern C, Castera L. Identification of high-risk subjects in nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023;29(Suppl):S196-S206. doi:10.3350/cmh.2022.0431.
Tjandra NW et al. Assessment of metabolic dysfunction-associated steatotic liver disease and liver fibrosis: a cross-sectional study in asymptomatic individuals in Greater Vancouver. J Clin Transl Hepatol. 2025. doi:10.14218/JCTH.2025.00109.
Younossi ZM, Henry L, Bush H, Mishra A. Clinical and economic burden of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Clin Liver Dis. 2018;22(1):1-10. doi:10.1016/j.cld.2017.08.001.
Gordon SC et al. Health care use and costs among patients with nonalcoholic steatohepatitis with advanced fibrosis using the Fibrosis-4 score. Hepatol Commun. 2020;4(7):998-1011. doi:10.1002/hep4.1524.
American Liver Foundation. Fibrosis: development [Internet; cited 2026 March]. Available from: https://liverfoundation.org/about-your-liver/how-liver-diseases-progress/fibrosis-scarring/
Roche Diagnostics. Method sheet: Elecsys® PRO-C3 #09088423500 V2.0 English
European Association for the Study of the Liver (EASL), European Association for the Study of Diabetes (EASD), European Association for the Study of Obesity (EASO). EASL-EASD-EASO clinical practice guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). Obes Facts. 2024;17(4):374-444. doi:10.1159/000539371. Epub 2024 Jun 7. Erratum in: Obes Facts. 2024;17(6):658. doi:10.1159/000541386.
Ulises Garay O, et al. Budget impact analysis of introducing the Elecsys® PRO-C3 assay as part of the ADAPT algorithm for assessing the severity of hepatic fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) in the UK. Roche Diagnostics International AG, Rotkreuz, Switzerland; Roche Information Solutions, Basel, Switzerland; Source Health Economics, Oxford, UK. Available from: https://medically.roche.com/global/en/medical-material.c755ca1a-ff16-4233-a102-f446a84aea7c.qr.html
European Parliament and Council of the European Union. Regulation (EU) 2017/746 on in vitro diagnostic medical devices. 2017 Apr 5.
Medical Device Coordination Group. MDCG 2019-11: Guidance on qualification and classification of software in Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
ISO 13485:2016 --> MD 742818 certificate issued by BSI Group The Netherlands B.V. [Internet; cited 2026 March]. Available from: https://www.evidencio.com/documents/QMS_certificate.pdf
ISO 27001:2022 --> K-0226082 / 1 certificate issued by Kiwa Nederland B.V. [Internet; cited 2026 March]. Available from: https://www.evidencio.com/documents/ISO_27001_certificate.pdf
navify® Algorithm Suite. Connectivity guide. Software version 2.4. User guide. Publication version 1.2.

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* FIB-4 Index is CE-marked IVD medical device (NB 2797) manufactured by Evidencio B.V. and distributed in the European Union by Roche Diagnostics GmbH.
The FIB-4 Index is not intended to replace clinical decision-making; it can only provide information to the healthcare professional on the risk stratification of advanced liver fibrosis (stage F3–F4). FIB-4 Index must be interpreted in conjunction with other diagnostic findings and clinical information in accordance with standard clinical management guidelines.¹
** ADAPT is CE-marked IVD medical device (NB 2797) manufactured by Evidencio B.V. and distributed in the European Union by Roche Diagnostics GmbH.
ADAPT is not intended to replace clinical decision-making; it can only provide information to the user healthcare professional on the estimation of the severity of liver fibrosis.²
Please note that navify algorithm ADAPT, by Evidencio can only be used with Elecsys® PRO-C3.²

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