HOW IS NASH DIAGNOSED?

As a silent and progressive disease, NASH can often remain undetected until the disease has already progressed to more serious and life-threatening stages. Early detection is one of the biggest challenges related to NASH diagnosis and management.1-3 But awareness and education can help change that.

CURRENT GOLD STANDARD: LIVER BIOPSY

Today, NASH diagnosis is often formally established using a liver biopsy. But this invasive procedure, while currently the gold standard, can be costly, uncomfortable, and potentially risky for patients.4 Additionally, the number of specialists available to perform and interpret a biopsy is very limited compared to the number of patients suspected to have NASH, making it impractical as part of a standard clinical routine.3 As such, liver biopsy represents a significant restriction for the larger population to access diagnosis.

OTHER DIAGNOSTIC METHODS

Alternative, noninvasive diagnostic methods include imaging-based techniques:4-6

  • Ultrasound (NAFLD)
  • Magnetic resonance imaging – MRI (NAFLD)
  • Transient elastography (NAFLD, Fibrosis)
  • Ultrasound elastography (Fibrosis)
  • Magnetic resonance elastography – MRE (Fibrosis)

Unfortunately, none of these methods were originally designed to diagnose all features of NASH. Although these techniques can prove powerful, some are too costly and time consuming. Further, all of them require expert use and interpretation that prevent broad access in primary care, further delaying or complicating the process of NASH diagnosis.

BLOOD TESTING

For years, specialists have been attempting to quantify a patient’s risk of liver disease using routine blood tests (e.g., liver enzymes levels [aspartate aminotransferase (AST), alanine transaminase (ALT)], platelets). However, these general biomarkers are not sufficient on their own to be reliable diagnostic tools for NASH and fibrosis, since typically, ALT and/or AST levels can be normal in patients with NAFLD and even NASH.5

Noninvasive diagnostic techniques, whether blood biomarkers or imaging biomarkers, are urgently needed to open access to accurate diagnosis of NASH to most of the widest population at need.7

If validated to replace liver biopsy, such biomarkers could significantly accelerate drug development in NAFLD. The FDA encourages sponsors to consider biomarker development.7

THE FUTURE OF NASH DIAGNOSIS

Fortunately, new, affordable, noninvasive diagnostic techniques are being developed for NASH that are demonstrating better precision. They are expected to provide much broader access to accurate NASH diagnosis in the coming years.

MAKING A DIAGNOSIS

The way we diagnose NASH is changing. But it’s not always straightforward. Download the current reference guidelines on NASH:

WHAT ARE THE OUTCOMES OF NASH?

EXPLORE OUR EDUCATIONAL BROCHURES

References

  1. Mayo Clinic. Nonalcoholic fatty liver disease. https://www.mayoclinic.org/diseases-conditions/nonalcoholic-fatty-liver-disease/symptoms-causes/syc-20354567?p=1. Accessed October 7, 2019.
  2. Polis S, Fernandez R. Impact of physical and psychological factors on health-related quality of life in adult patients with liver cirrhosis: a systematic review protocol. JBI Database System Rev Implement Rep. 2015;13(1)39-51.
  3. Younossi, ZM, Koenig AB, Abdelatif D, et al. Global epidemiology of nonalcoholic fatty liver disease -Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016;64(1):73-84.
  4. Chalasani N, Younossi Z, Lavine JE, et al. The diagnosis and management of non- alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012;55(6):2005-2023.
  5. 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 for the management of non-alcoholic fatty liver disease. J Hepatol, 2016;64(6):1388-1402.
  6. Rinella ME, Sanyal AJ. Management of NAFLD: a stage-based approach. Nature. 2016;13:196-205.
  7. Center for Drug Evaluation and Research (CDER). Noncirrhotic nonalcoholic steatohepatitis with liver fibrosis: developing drugs for treatment, guidance for industry, draft guidance. https://www.fda.gov/media/119044/download. Published December 2018. Accessed October 11, 2019.