FAST Score: Innovative Non-Invasive Technology to Determine Risk of Advanced Liver Disease

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By Jon Gingrich

Nonalcoholic fatty liver disease (NAFLD), which affects roughly 100 million Americans is estimated to cost the U.S. healthcare system $103 billion annually. The prevalence of NAFLD reflects the rising trend of obesity in the United States and is now the most common form of chronic liver disease and a becoming the main indication for liver transplant.  Identifying the economic burden of NAFLD underscores the need for readily available treatments and early detection to save money and lives.

To cost effectively address this alarming trend, FibroScan is an innovative and FDA cleared technology solution for the diagnosis and monitoring of adult patients as part of an overall evaluation of liver health. It non-invasively quantitatively estimates liver stiffness with patented VCTE™ and liver fat with CAP™. FibroScan is designed as a portable, point of care tool, to be operated by a medical assistant and interpreted by a healthcare professional.  

Managing the NAFLD Epidemic

A growing number of primary care providers and liver specialists recognize that nonalcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease in developed countries. Fortunately, NAFLD can be reversible if caught in the early stages, and innovative examination technology makes it possible to quickly and non-invasively combat the disease. 

Current treatments for NAFLD are to control body weight by changing lifestyle and improving insulin resistance. If body weight is decreased through a medium level of dietary restrictions and increased body activity by 5–10%, it can reduce the fat accumulated inside the liver by up to 40%. Also, exercise and diet can reduce the fat accumulation in the liver and improve hyperlipidemia, hypertension and insulin resistance.

There are several compounds under development to treat NALFD and the liver complications of NASH, with the first agent anticipated later this year.  It is expected that over the next few years, the pharmaceutical treatment market NAFLD could potentially reach $35 billion.

June 12 – International NASH Day
Non-alcoholic steatohepatitis (NASH), the progressive form of non-alcoholic fatty liver disease (NAFLD), is a hidden epidemic affecting an estimated 357 million people worldwide by 2030.  Because NASH symptoms are often not overt, NASH is often underdiagnosed and underreported. International NASH Day is held annually on June 12 to increase awarenessabout NASH and to promote early intervention. Unchecked, NASH may lead to cirrhosis, liver cancer, and liver transplant. 

The American Diabetes Association (ADA) and the American Association for the Study of Liver Diseases (AASLD) recommend assessment of people with Type 2 diabetes who are suspected of having NALFD or NASH.  While routine screening is not recommended, they do recognize FibroScan, which measures a quantification estimate of liver fat, as part of an overall approach to assessing those Type 2 diabetics with a high suspicion of NAFLD or NASH. 

FAST Score

To enhance the role of FibroScan for the assessment of active fibrotic NASH, Echosens has introduced the FAST score, a cost-effective tool to help identify individuals at risk for active fibrotic NASH, an asymptomatic progressive liver disease that leads to increased liver-related mortality and morbidity. 

Recently featured in The Lancet Gastroenterology & Hepatology, the FAST score is a calculation based on two physical biomarkers: liver stiffness by VCTE and CAP together with aspartate aminotransferase (AST), a commonly collected blood biomarker of inflammation.

The FAST score was derived from a prospective, multi-center study with 350 patients undergoing a liver biopsy and then validated in seven external cohorts with 1,026 patients. The FAST score provides healthcare providers with an efficient and cost-effective tool to help non-invasively identify at-risk patients with progressive NASH, that merit consideration for further treatment or monitoring for progressive disease. This is very timely and significant because the efficient identification of active fibrotic NASH has long been a challenge for drug companies, and this need will grow with availability of pharmaceutical treatments.

FAST is inexpensive, and as part of an overall patient care plan, can reduce unnecessary invasive testing and prove to be a quick, point-of-care tool that mitigates the need to send out for complex and expensive blood tests. Moreover, FAST is simple to determine and interpret – requiring only three numbers entered into a calculator to get a probability score of active fibrotic-NASH. 

The simplicity of the FAST score makes it easy to access and simple to interpret. This enables front-line health care professionals to calculate the score with an online calculator, making this an economical and effective part of a non-invasive approach to determining if a patient is at-risk for progressive NASH and requires an immediate specialist referral or increased monitoring.

Innovative Liver Examination Tools: Important Alternative to Invasive Assessment

Innovative technology, like FibroScan, provides consistent information about the presence or status of disease, which is important in the diagnosis and monitoring of NAFLD. Healthcare Providers can get rapid results and test scores and analyze the data and information in real time to refer patients to a specialist or recommend changes to their overall care plans, if needed. 

This type of technology represents a vast improvement over the traditional approach of identifying liver disease with a blood test alone, which reveals liver enzymes that are released after a liver cell dies and may suggest inflammation. As appropriate and needed, this is followed by extracting a liver tissue sample — a percutaneous liver biopsy. This allows doctors to see signs of scar tissue and ballooning under a microscope to determine how far the disease has progressed. 

This standard method, however, has been brought into question not only because it is invasive and often painful, but also for its inaccuracy. In fact, scientists estimate that more than 30% of biopsy diagnoses may be wrong. Additionally, it adds another layer of cost to the diagnosis.

The point of non-invasive, painless technology is that these tools can quickly and easily measure the amount of liver stiffness and fat to better target more expensive or more invasive diagnostic procedures – saving time and resources for clinicians by eliminating patients who don’t need additional assessment. 

Jon Gingrich is CEO of Echosens North America.

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