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About liver disease

NASH Diagnosis

Nonalcoholic Steatohepatitis, or NASH, is a silent, asymptomatic disease. Patients with NASH are often unaware of their disease until their condition progresses to more serious and life-threatening stages. The identification of patients with NASH and early fibrosis is a key area of major unmet need since medical intervention at this stage can help prevent or attenuate adverse clinical outcomes. The Food and Drug Administration, or FDA, recognizes that the use of liver biopsies in NASH clinical trials poses significant logistical challenges and that noninvasive biomarkers are needed.1

Today’s challenge in diagnosing NASH

There are currently no FDA-cleared diagnostic tests specifically designed for the identification of patients with NASH. The available diagnostics are:

  • Either general tools for the management of chronic liver disease patients, such as Transient Elastography or Magnetic Resonance Elastography,
  • Or are not widely accessible due to high cost and/or necessity of hospital based equipment, such as MRI-based technologies.

Today, the clinical standard to formally diagnose NASH and stage fibrosis is to perform a liver biopsy. When its results show steatosis, ballooned cells and inflammation, with or without fibrosis, the patient is diagnosed with NASH. Physicians use various scoring scales to assess the extent of disease severity and fibrosis, such as the NAFLD Activity Score, or NAS, (0 to 3) and the NASH Clinical Research Network fibrosis staging system (F0 to F4).

Liver biopsy remains a costly and invasive procedure for the patient. It presents a number of limitations, including pain and discomfort, consequently leading to a low level of patient acceptance. In addition, there are a limited number of specialists who are able to perform and interpret liver biopsies when considering the anticipated increase in clinical cases over the next 10 years (1,000 to 2,000 practicing hepatologists against 27,0 million adults with NASH expected by 2030 in the US).2   

The treatment of NASH being an urgent public health challenge, there is a high need for an easy-to-access tool as an alternative to liver biopsy.

The availability of such a test would help in solving NASH under-diagnosis, by supporting physicians in identifying patients with NASH and fibrosis who would benefit from treatment, and thus directly address the clinical gap.

Our IVD test for the diagnostic of NASH

As part of our strategy to address the unmet needs in NASH, we are advancing a diagnostic program based on the discovery that specific microRNA, or miRNA, are expressed at different levels in patients with NASH.

This discovery kicked off a multi-year effort that has resulted in the development of what we target to be the first validated diagnostic test to identify patients with NASH who may be appropriate candidates for treatment.

In January 2019, we signed a licensing agreement to expand the access to NIS4, our in-house multi-biomarker test for NASH, to provide the clinical research community with a non-invasive tool to identify and monitor patients with NASH and significant fibrosis, and thus address the current bottleneck in NASH diagnosis.

1Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment; Guidance for Industry; FDA 2018
2Estes, C. et al., Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology, 2018. 67(1): p. 123-133

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