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  5. Clinical Benefits of The Enhanced Liver Fibrosis Test

Clinical Benefits of The Enhanced Liver Fibrosis (ELF) Test 

Assess the Risk of NAFLD/NASH Progression and Liver-related Events with a Simple Blood Test

The Enhanced Liver Fibrosis (ELF™) Test is a non-invasive blood test that measures three direct markers of fibrosis. Direct assessment of fibrosis has proven valuable for identifying patients at risk of progressing to cirrhosis and/or liver-related events.

The most widely studied direct marker is the ELF Test which can assess active, dynamic fibrosis rather than the damage it has caused. This allows the ELF Test to be used as a prognostic marker to identify the patients most at risk of progression to cirrhosis and LREs in patients with chronic liver disease. 

Why choose the ELF Test?

Characteristics of an Ideal Non-invasive Liver Fibrosis Test1-6

Validated Across Multiple Settings

Primary Care

Secondary Care

Tertiary Care
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Applicability in Different Patients/Conditions

Adults

Children

Obesity

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Economic Health Value

(Cost effectiveness)

Add clinical value

Decrease unnecessary referrals

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Access

Simple blood test

Large installed base

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Clinical Benefits of ELF

ELF U.S. Test Kit

The Enhanced Liver Fibrosis test is a simple blood test available to all healthcare practitioners and patients.

A simple blood test. Any patient. Any provider.

Blood-based tests can readily support high-volume testing, do not require patient access to specialized imaging equipment or highly trained operators, and generally have lower incidence rates of failure and unreliable results reported for imaging modalities.7,8

  • Access non-invasive testing with a simple blood test available to all healthcare practitioners and patients, including those with type 2 diabetes mellitus and obesity.8,9
  • Improve patient care by identifying NAFLD patients and stratifying those at risk of progressing to cirrhosis and LREs.10
  • Enhance prognostic patient management with a test that has been shown to outperform biopsy for the risk assessment of progression to cirrhosis and LREs.10
ELF Etiologies
Multiple publications support the clinical utility of ELF across diverse forms of chronic liver disease.11-15

ELF is featured in more than 200 peer-reviewed publications and has been evaluated in multiple forms of chronic liver disease

  • Non-alcoholic fatty liver disease (NAFLD)
  • Non-alcoholic steatohepatitis (NASH)
  • Alcoholic liver disease (ALD)
  • Primary sclerosing cholangitis (PSC)
  • Primary biliary cirrhosis (PBC)
  • Chronic HBV infection (CHB)
  • Chronic HCV infection (CHC)
  • Mixed chronic liver disease etiologies

In a UK study, the ELF test detected 5x more cases of advanced fibrosis, 3x more cases of cirrhosis, and reduced unnecessary referrals by 80%.

Reduce Unnecessary Referrals and Save Healthcare Costs

To reduce the burden of unnecessary referrals and improve detection of advanced liver disease, a “NAFLD pathway” was developed comprised of testing first with FIB-4 and reflexing indeterminate results to ELF. After 2 years the pathway data was compared to the Standard of Care.6

Multiple NAFLD/NASH International Clinical Guidelines Recommend ELF

The ELF Test is included in multiple international clinical guidelines supporting ELF both as a diagnostic and prognostic marker in NAFLD/NASH.

American Association for the Study of Liver Diseases (AASLD)

“An elevated FIB-4 followed by elevated liver stiffness or an increased ELF can be used as a sequential strategy to identify advanced fibrosis.”

Rinella M, et al. Hepatology (Baltimore, Md.) vol. 77,5 (2023): 1797-1835. doi:10.1097/HEP.0000000000000323

American Association of Clinical Endocrinology (AACE)

"Clinicians should consider persons belonging to the 'high-risk' groups who have an indeterminate or high FIB-4 score for further workup with an LSM (transient elastography) or ELF test, as available."

Cusi K, et al. Endocrine Practice 28 (2022) 528-562.

American Gastroenterological Association (AGA)

“We concluded that the ELF Test may be used as a confirmatory prognostic test in patients with lean NAFLD until further data are available.”

Long, M, et al. Gastroenterology. https://doi.org/10.1053/j.gastro.2022.06.023

Asian Pacific Association for the Study of the Liver (APASL)

"More specific fibrosis markers are needed in specialist settings to guide the management of patients. The Enhanced Liver Fibrosis Test has been tested in multiple observational studies and clinical trials with good overall accuracy." 

https://pubmed.ncbi.nlm.nih.gov/33006093/

British Society of Gastroenterology (BSG)

"Patients with intermediate risk should undergo second-line non-invasive testing either by additional tests like ELF test or FibroTest or by measuring liver stiffness.7,8 If advanced fibrosis is ruled out, patients can be treated as low risk and referred back to primary care."

https://www.bsg.org.uk/clinical-articles-list/naflddiagnosis-assessment-and-management/

Chronic Liver Disease Foundation (CLDF) 

"To date, the ELF score demonstrates good correlations with progression of fibrosis in a number of chronic liver diseases."

Younossi ZM, et al. Am J Gastro. 2020;00:1–9. https://doi.org/10.14309/ajg.0000000000001054

European AIDS Clinical Society (EACS)

"Whenever imaging tools are not available or feasible, serum biomarkers and scores (such as ELF) are an acceptable alternative for the diagnosis of NAFLD in PLWH."

EACS Guidelines. version 11.0, October 2021.

European Association for the Study of the Liver (EASL)

"Surrogate markers of fibrosis (NFS, FIB-4, ELF Test or FibroTest) should be calculated for every NAFLD patient, in order to rule out significant fibrosis (≥F2)."

EASL–EASD–EASO. J Hepatol. 2016;64:1388–1402.

French Association for the Study of the Liver (AFEF)

“A specialized blood marker (Fibrometer, Fibrotest, ELF) or a measurement of liver stiffness must be performed in second intention if a simple blood marker suggests the presence of an advanced chronic liver disease”

Boursier J, et al. AFEF. 2020
https://afef.asso.fr/wp-content/uploads/2020/07/DNI-VERSION-FINALE-RECO-2020.pdf

Korean Association for the Study of the Liver (KASL)

"When subjects are classified as intermediate risk by TE, FIB-4, or the NFS, additional tests such as M2BPGi, AsAGP, ELF, SWE, or MRE can be performed."

Kang H, et al. Clinical and Molecular Hepatology 2021;27:363-401
https://doi.org/10.3350/cmh.2021.0178

The National Institute for Health and Care Excellence (NICE) 

"Consider using the Enhanced Liver Fibrosis (ELF) Test in people who have been diagnosed with NAFLD to test for advanced fibrosis."

National Guideline Centre; Royal College of Physicians. NICE guideline NG492016. ISBN 978-1-4731-1996-3.

Spanish Association for the Study of the Liver (AEEH)

"Patients in the gray zone could benefit from a second non-invasive method such as ELF or Owl-liver, which would allow defining which patients are at risk of advanced fibrosis."

Romero-Gómez M, et al. Gastroenterología y Hepatología. https://doi.org/10.1016/j.gastrohep.2022.04.001

Diagnostic Accuracy and Cost-effectiveness

ELF Ranks First in Analysis of Cost-effectiveness 

The population considered for analysis were persons with NAFLD who were suspected of having developed NASH with fibrosis or cirrhosis. This analysis found that, given a retesting frequency of 3 years, ELF was the highest ranking of the 13 tests compared at a cost-effectiveness threshold of £20,000 per QALY gained, followed by Siemens Healthineers ARFI.

The Guideline Development Group concluded that ELF is both the most cost-effective and the most appropriate test for advanced fibrosis in adults with NAFLD and should be offered to people with NAFLD.16

Advanced fibrosis test ranking based on diagnostic accuracy and cost-effectiveness

Test

Mean cost (£)

Mean QALYs

NMB (£) at £20,000/QALY

Rank

ELF Test at 10.51

9,632

13.70

264,301

1

ARFI at 4.24

10,142

13.71

264,060

2

MRE at 4.15

10,259

13.70

263,751

3

FibroTest at 0.47

9,949

13.68

263,596

4

NFS at 0.676

9,208

13.64

263,541

5

TE (M) at 7.8–7.9

11,056

13.72

263,426

6

APRI at 0.98-1 

10,184

13.68

263,403

7

FIB-4 at 1.45

11,295

13.73

263,277

8

BARD at 2

11,350

13.72

263,105

9

AST/ALT at 0.8

11,280

13.71

262,996

10

TE (XL) at 5.7

11,685

13.73

262,964

11

No test—monitor all

12,319

13.75

262,641

12

Ferritin at 2x

9,206

13.58

262,433

13

Liver biopsy

11,543

13.68

262,071

14

No test—monitor nobody

7,563

13.48

261,939

15

Cost-effectiveness = the value of the net monetary benefit (NMB) attributed to every test.

The comparator with the highest NMB is the most cost-effective option at the specified £20,000 per extra quality-adjusted life year (QALY) threshold.

The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed.

In the U.S., the ELF Test is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH) to assess the likelihood of progression to cirrhosis and liver-related clinical events.

References