FiSPlat

FiSPlat, a primary care tool for liver fibrosis screening

FibroScan Screening Platform (FiSPlat), is a non-invasive way to diagnose early-stage liver cirrhosis, known as liver fibrosis

Liver fibrosis happens when a person’s healthy liver tissue becomes scarred due to inflammation or injury. Fibrosis may reverse if the cause of scarring ceases. But if the cause is ongoing, fibrosis can progress. Fibrosis often progresses silently, going undetected because those at risk are not evaluated.

If effective treatment to control or cure the underlying disease is implemented in early stages, liver fibrosis can regress. Unfortunately, most patients are diagnosed at an advanced stage.[1] When more liver tissue becomes damaged, fibrosis may develop into liver cirrhosis, where scar tissue on the organ prevents it from working properly.

Cirrhosis is a chronic liver condition that is caused by numerous factors. These include too much alcohol consumption, infection from hepatitis C and non-alcoholic fatty liver disease. Complications from the condition are responsible for 1.3 million deaths worldwide every year.[1] They rank as the fourth most common cause of death in Central Europe.[2]

Early detection and intervention would be most effective in primary care, where many at-risk people are being treated for conditions such as obesity or type 2 diabetes. Primary care health professionals, therefore, are well-placed to recognise those at risk.[3] But they lack tools to screen for and detect early-stage liver disease, making cirrhosis one of the most difficult to prevent.

Traditionally liver biopsy has been used to diagnose cirrhosis, but this is an invasive procedure that may lead to complications. Conventional imaging techniques are another option, but these are not that sensitive.

Measuring liver stiffness, a physical parameter which can indicate cirrhosis progression is a non-invasive, low-risk, alternative means of diagnosis. But the technology to measure liver stiffness has not been available in a primary care setting, until now.

Now clinicians can screen at-risk communities

FiSPlat is the result of an EIT Health-supported project. The tool uses transient elastography technology (a combination of ultrasound and low-frequency elastic waves) to non-invasively measure liver stiffness. By using the tool, healthcare professionals can better identify liver disease and make treatment decisions earlier, without the need for biopsy.

The technology consists of a tablet-sized non-invasive device, a reader and a docking station. It is designed to be fast, portable and easy to use, making it suitable for use in primary care. The tool is also cost-effective, as early detection, referral and treatment means less pressure for acute centres.[1]

EIT Health provides access and support

FiSPlat is the result of years of research. It follows another EIT Health-supported project, LiverScreen.

LiverScreen developed a personalised screening programme which used novel technology to identify people with pre-symptomatic, significant chronic liver disease among the general population.

Following the discovery of transient elastography, the consortium of partners involved in LiverScreen wanted to create a device that used the technology in a primary care setting.

In 2021, the FiSPlat device obtained the Medical Device CE mark and is now in its pre-launch phase in UK, Spain, Germany, France and the US.

EIT Health’s support has been central from the beginning. We provided FiSPlat with financial assistance and access to our extensive professional network. This helped with the commercialisation and positioning of the technology at a global level.

EIT Health will be crucial in raising awareness of the liver cirrhosis among patients and encouraging key stakeholders and policy makers to adopt the solution.

External Partners

External Partners include Echosens and ELPA.

References

[1] Moon et al (2019) Contemporary Epidemiology of Chronic Liver Disease and Cirrhosis. Clin Gastroenterol Hepatol. 2020 Nov;18(12):2650-2666. doi: 10.1016/j.cgh.2019.07.060. Epub 2019 Aug 8. Accessed at https://pubmed.ncbi.nlm.nih.gov/31401364/. In November 2021

[2] Gu at al (2021) Trends and the course of liver cirrhosis and its complications in Germany: Nationwide population-based study (2005 to 2018), THE LANCET; Accessed at https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00226-X/fulltext, In November 2021

[3] Fabrellas et al (2018) “Prevalence of hepatic steatosis as assessed by controlled attenuation parameter (CAP) in subjects with metabolic risk factors in primary care. A population-based study:”