Noninvasive Testing

Only a doctor can diagnose a liver disease and it is complex, but if you as a patient are better informed, your ability to understand the diagnosis and to ask the right questions will enable you to have a better dialog with your doctor. Learning about the tools (besides biopsy) that you can use to monitor the progress of your liver disease will better prepare yourself to engage with your physician. These tools are not widely known, so who knows, you might even teach your physician something new!

There are two main types of noninvasive tests: blood-based and imaging-based. Blood-based tests are more widely available, because all they require is a simple blood draw. They may also be called “biomarker” tests, which is just another way of saying labs will be looking for certain compounds in your blood that indicate different things. Imaging-based tests are less widely available, but if you can find them, they may help paint a more vivid picture of what is going on in your body. Imaging-based tests are often done with ultrasound or MRI devices equipped with specialized liver software.

Blood-based Tests

FIB-4 Index

What it measures: fibrosis (scarring)

The FIB-4 Index is a blood-based test that looks at underlying fibrosis that can be used as a measure to help determine MASLD/MASH status. While originally developed to detect liver fibrosis among patients with Hepatitis C and HIV, FIB-4 scoring has been increasingly used by the diabetes and MASLD/MASH communities. The FIB-4 scoring system is determined from the values of patient age, platelet count, aspartate aminotransferase (AST), and alanine aminotransferase (ALT). Because all of these tests are available to primary care physicians, FIB-4 is a highly accessible and affordable screening tool.

Unlike some other tests, FIB-4 looks solely at fibrosis, not taking into consideration other factors important for diagnosis and monitoring of MASLD/MASH such as steatosis and activity. While it is fairly limited in this sense, the high accuracy in detection of fibrosis makes it a strong starting point for MASLD/MASH diagnosis that can help the right patients get on track for further testing and treatment. If you have your platelet count, AST, and ALT values from a previous bloodwork, you can enter them yourself into online calculators, such as this one.

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LIVERFASt

What it measures: steatosis (fattiness), activity (inflammation and ballooning), fibrosis (scarring)

LIVERFASt is a blood-based test developed by Fibronostics that looks at steatosis, activity, and fibrosis using an algorithm to analyze 10 distinct biomarkers. LIVERFASt measures the presence and extent of steatosis, activity , and fibrosis to determine level of MASLD/MASH. The algorithm is key to LIVERFASt and has been trained and tested on thousands of patient cases around the world. Once a lab draws blood and assesses the 10 biomarkers, the results can be entered into the LIVERFASt online portal, which uses the algorithm to calculate scores. The use of the algorithm helps improve consistency in results, which has proven to be a challenge for human pathologists. The algorithm analyzes the biomarker results and assigns patients a score for fibrosis, activity, and steatosis.

what does liverfast assess

These scores, in combination with demographic information (age and gender), are used to classify patients into different levels of MASLD/MASH. The ability of the LIVERFASt test to distinguish between levels of severity of MASLD and MASH addresses one of the more challenging aspects of diagnosis. With its user-friendly results and graphics (shown above), LIVERFASt allows this information to be obtained simply and affordably enough to encourage regular retesting and restaging. The accessibility of this technology has the potential to improve disease management and understanding of progress in a manner both attainable for and accessible to patients and providers.

Learn more:

https://fibronostics.com/liverfast/

Imaging-based Tests

FibroScan

What it measures: fibrosis (scarring), steatosis (fattiness)

FibroScan is an imaging-based test developed by Echosens that looks at liver fibrosis and steatosis using transient-elastography technology. FibroScan can be used on patients in need of staging of their MASLD/MASH, whether their condition is suspected or biopsy-confirmed. FibroScan works similarly to an ultrasound, emitting a small pulse of energy, called a shear wave. The speed of the shear wave is measured as it travels through your liver, generating two scores to determine overall liver health. The first score measures liver stiffness and the second score measures liver fat. In combination, these scores can help you understand your overall liver health and how it may change over time with lifestyle or medical interventions. The only thing you will feel while taking the test is a light vibration on your skin and the entire procedure takes less than 10 minutes.

Depending on where you get a FibroScan may determine the scoring system used in your diagnosis. Typically, a 5-point scoring system is used to grade the degree of liver fibrosis, from F0-F4. Scores from the FibroScan will be in kilopascals (kPa), ranging from 2 to 75 kPa. Normal livers fall between 2 and 7 kPa, with anything outside this range indicating some degree of liver disease. When determining your actual fibrosis score, in addition to your fibrosis measurement, your provider will take into consideration your health history and the grade of steatosis.

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Hepatoscope

What it measures: steatosis (fattiness), fibrosis (scarring)

The Hepatoscope is an FDA-approved ultrasound system developed by E-Scopics that uses two technologies, two-dimensional transient elastography (2DTE) and shear wave ultrasound, to non-invasively measure liver fibrosis and steatosis.

The device attaches to a laptop or tablet and guides the user to take clear images. It measures liver stiffness in kilopascals (kPa). Normal results are usually between 2 and 7 kPa. Your result may be higher than the normal range if you have liver disease. The highest possible result is 75 kPa. Hepatoscope also checks fat levels in the liver by analyzing how sound waves travel through it, using measures like attenuation, backscatter, and speed of sound. The system has a built-in quality score that helps ensure accurate readings, even when used by beginners or experts. These results give your doctor important information about your liver’s health and can be used for early detection, diagnosis, and monitoring of liver disease.

Learn more:

https://www.e-scopics.com/

Hepatus

What it measures: steatosis (fattiness), fibrosis (scarring)

Hepatus is an imaging-based test developed by Mindray that combines regular ultrasound pictures with a method called transient elastography to measure liver steatosis and fibrosis. A Hepatus scan is quick and results can be ready in seconds once the probe is placed on your skin. The output gives two numbers: one showing how much fat is in the liver, and another showing how stiff it is. These numbers help your doctor decide if you have liver disease, how advanced it may be, and how it should be monitored over time.

The Hepatus scan also creates clear images of the liver that help doctors look for signs of disease. These images can show changes in the liver tissue, possible signs of liver cancer (HCC), and fluid buildup in the belly (ascites). The test can also check blood flow in the liver’s main vein, called the portal vein. This helps doctors see if blood is moving normally or if there are signs of portal hypertension, which is high pressure in the liver’s blood vessels.

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LiverMultiScan

What it measures: fibrosis (scarring), steatosis (fattiness), activity (inflammation and ballooning), iron

LiverMutiScan (LMS) is an imaging-based test developed by Perspectum that uses multiparametric MRI to look at liver activity, fibrosis, steatosis, and iron levels. The results are in the form of three reports: cT1, T2, and PDFF. Scans take about 15 minutes in an MRI machine and require no contrast injections. Images acquired at sites are analyzed by teams at Perspectum Diagnostics using proprietary algorithms to generate an easy to interpret report.

cT1, or corrected T1, is a metric that corresponds to activity and fibrosis. In comparison to T1, cT1 is more reliable as it accounts for the level of iron in the liver, which can interfere with MRI measurement and lead to underestimation of disease.

results of liver screening using LiverMultiScan

Example cT1 images shown indicate how cT1 depends on fibrosis and activity in patients without high levels of steatosis. Normal range of 633 to 749 ms derived from 95% confidence interval of the distribution of cT1 values in healthy subjects with BMI <25kg/m2 and liver fat <5%. [1]

T2 is a biomarker that measures the amount of iron in the liver. This measurement is the value cT1 uses to adjust for levels of liver iron that could interfere with MRI results. Tissues with high iron typically have very low T2, while tissues with low iron have higher T2 values. In addition to being used in the cT1 measurement, T2 is clinically important on its own. The ability to detect and monitor the treatment of high iron levels can help patients and doctors manage the condition and reduce the impact of high iron on progression to advanced liver disease.

PDFF, or proton density fat fraction, measures the amount of fat in tissue. Specifically, LMS uses the IDEAL (Iterative Decomposition of water and fat with Echo Asymmetry and Least squares estimation) measurement, which accounts for the impact on the MRI signal of iron in the liver and the multi-spectral nature of liver fat and is IP licensed from the University of Wisconsin.

Because it includes measurements for fibrosis, steatosis, activity, and iron levels in the liver, LMS provides a comprehensive non-invasive picture of liver health. That being said, it is not meant to be used as the only metric in diagnosis, but rather in conjunction with liver function tests, blood tests, ultrasound scanning, and liver biopsy at the discretion of a qualified clinician.

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Velacur

What it measures: fibrosis (scarring), steatosis (fattiness)

Velacur is an imaging-based test developed by SonicIncytes that looks at liver fibrosis and steatosis using ultrasound technology. Velacur can be used to help diagnose and monitor MASLD/MASH and is a quick and comfortable procedure. Velacur uses technology similar to MRI elastography, using multiple frequency steady-state waves to generate a 3D liver tissue sampling.

Your physician or a trained technician performs the procedure on you while you are lying down, placing a gently vibrating pad under the right side of your back and running an ultrasound probe over your ribs to scan your liver. The entire process takes only about 10 minutes and results are immediately available.

Results from a Velacur reading can be seen in the image above. The two main results from the scan are elasticity and attenuation. Elasticity is a measure of fibrosis and attenuation is a measure of steatosis. Together, these scores will allow your provider to diagnose and monitor the severity of your MASLD/MASH. In comparison to transient or ultrasound elastography, Velacur’s advantages are deeper tissue measurement, larger tissue sampling, 3D data acquisition, using a single probe for all body types, fewer user readings required, machine-learning enhanced image guidance, and greater comfort.

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