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A less painful approach: New non-invasive test to predict progression of liver disease

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(BPT) - Each year, 9 to 15 million Americans may unknowingly be affected by a silent, sometimes deadly attack on their liver. Non-alcoholic steatohepatitis, or NASH, a serious form of non-alcoholic fatty liver disease (NAFLD), is the underlying cause of these attacks. An estimated 80-90 million Americans currently have diagnosed or undiagnosed NAFLD. Despite the grim statistics, the good news is there is a new test that makes it easier to identify patients at risk of disease progression to severe liver outcomes, which can create an opportunity to prevent further damage to the liver when combined with lifestyle changes.

What are NAFLD & NASH?

NAFLD — a disease that impacts up to 25 percent of the U.S. population — is an excessive fat buildup in the liver which often causes inflammation that may lead to liver damage and scarring (fibrosis). Over time, as fibrosis causes the loss of healthy liver tissue, it can progress to cirrhosis. This 'silent killer,' better known as NASH, can cause liver failure and liver cancer if untreated. In fact, by 2030 it is estimated NASH will be the leading cause of liver transplants in the U.S.

Risk Factors for NAFLD & NASH

Certain risk factors like obesity, type-2 diabetes, and high cholesterol make people more likely to develop NAFLD. With the rise of obesity across America, NAFLD prevalence continues to increase in men, women and children. However, some people have no known risk factors.

"It‘s very common for a person with early-stage NASH to be unaware their liver health is slowly declining because they may not feel sick or look unwell," said Dr. Zobair Younossi. "Typically, we see people experience symptoms when fibrosis turns to cirrhosis but that can vary. This is why early-stage detection and intervention is so crucial."

Tony Villiotti's Story

Tony Villiotti was seeing his general practitioner every six months for routine diabetes care. "At one appointment after some blood work, he told me that my liver enzymes were elevated, and that I had a fatty liver. He didn't make a big deal of it, so I didn't think much of it," said Villiotti. In 2014, nine years later, he asked Villiotti to have an ultrasound done in addition to normal blood work. "At the next appointment, he told me I had NASH, and I also might have cirrhosis. I was shocked. First, I had never heard of NASH, and second, I always thought cirrhosis was a disease associated with alcohol."

In 2017, on St. Patrick's Day, Villiotti visited his doctor, and she revealed he had liver cancer. "I went nine years between my fatty liver diagnosis and my cirrhosis diagnosis — nine years. That was 18 doctor's visits. I'm no physician, but I know the cirrhosis didn't occur between my 17th and 18th visit. It happened over time, but I was not aware of it. My experience has been, in some cases, that the patient needs to initiate those discussions. If you're aware of it early, you can take action early, and hopefully stop the progression."

Early Detection

Despite affecting millions of Americans, early detection of patients at increased risk of disease progression in NASH can be challenging. The current standard for assessing liver fibrosis is a liver biopsy which involves an in-hospital procedure where a needle is inserted into the liver to collect a sample. Although the first known liver biopsy was performed more than 100 years ago, patients still are subjected to this invasive procedure and can face extreme discomfort and pain.

NASH Symptoms:

  • Unexplained weight loss
  • Decreased appetite
  • Abdominal pain or discomfort
  • Feel weak or lethargic
  • Exhaustion
  • Nausea and vomiting

"Early and accurate identification of patients at risk of progressing to cirrhosis and liver-related events (LREs) is crucial in helping the patient prevent additional inflammation and liver decline," said Dr. Chuck Cooper, Chief Medical Officer, Siemens Healthcare Diagnostics, Siemens Healthineers. "Over the last decade, non-invasive methods have made great strides. These tests will undoubtedly make detection easier for the patient and help shape how we evaluate indications for biopsy in the future."[1]

Recently, a simple, effective blood test to assess the likelihood of progression of advanced liver fibrosis to cirrhosis and liver-related clinical events in patients with NASH became available in the U.S. The ELF Test is available at community laboratories and offers patients a minimally invasive tool for determining the risk of disease progression for earlier intervention.

Prepare a simple checklist of information to discuss with your doctor:

  • List of medications – some may cause fat buildup in the liver
  • Alcohol use
  • Diet & exercise habits
  • Known NAFLD risk factors

Non-Invasive Liver Disease Prognostic Tool

The ELF Test uses a routine blood sample and mathematical algorithm to generate a score that assesses the extent of liver damage. Clinicians can then utilize the score to understand the likelihood of progression to cirrhosis and other life-threatening liver-related clinical events.

"The ELF Test provides clinicians and patients a valuable prognostic tool to help catch severe liver damage before it reaches that point," said Cooper. "We know that early intervention combined with lifestyle changes can positively impact patient outcomes, so this less invasive, easy-to-access test is a significant step in the right direction. Further, the ELF Test is strongly recommended in the 2022 American Association of Clinical Endocrinology (AACE) NAFLD Clinical Practice Guidelines. The guideline underscores the value of utilizing direct blood-based biomarkers in the NASH care continuum and also represents an opportunity to incorporate preventative care to address the anticipated tsunami of patients from developing cirrhosis or life-threatening liver-related events."

With the ELF Test, your healthcare team has the tools to catch liver disease before it progresses and create a treatment plan that works for you. This may include lifestyle changes to prevent future damage to your liver. Speak with your doctor to know your liver health status today. Visit siemens-healthineers.us/elf for more information.



[1] Liver biopsy is currently the gold standard for diagnosing NASH and assessing fibrosis. In the U.S., the ELF Test is not for use in the diagnosis of NASH or for the staging of fibrosis. The ELF Test provides prognostic information supplemental to biopsy to assess the likelihood of progression to cirrhosis and liver-related clinical events.