Diagnosing NASH: Testing for Non-Alcoholic Steatohepatitis and Non-Alcoholic Fatty Liver Disease
There is currently an unmet need regarding NASH and NAFLD: Non-invasive tests for screening, diagnosis, staging and monitoring therapeutic response to these diseases.
Here at Labcorp, we are helping change this. It started in September 2020, when Labcorp and GENFITTM, a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, announced an agreement to license a new technology - NIS4 - to help identify patients with at-risk non-alcoholic steatohepatitis (NASH).
Now, Labcorp has launched NASHnextTM, a novel, noninvasive diagnostic test for nonalcoholic steatohepatitis (NASH). The test, offered exclusively in the U.S. and Canada through Labcorp, is powered by NIS4™, GENFIT’s proprietary diagnostic technology that uses a novel, blood-based molecular biomarker test to identify NASH and significant fibrosis, also referred to as at-risk NASH, in patients with at least one metabolic risk factor.
In addition, Labcorp offers numerous tests specifically designed to help physicians with their diagnoses of NASH and NAFLD.
Labcorp can help meet your NAFLD-NASH needs
Contact a Labcorp representative to learn more about how we can help meet your NASH and NAFLD testing needs.
NAFLD/NASH Testing offered by Labcorp
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Test: 385375
AST to Platelet Ratio Index (APRI) is reported to be a simple, noninvasive, and readily available laboratory test index that can stratify patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) who are at high or low risk for significant fibrosis and cirrhosis with high degree of accuracy.
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Test: 550659
The Enhanced Liver Fibrosis (ELF™) blood test is a simple, accurate, non-invasive test that provides a simple, unitless numeric score that is generated via an algorithm for use in advanced liver fibrosis. It is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-hepatitis (NASH) to assess the likelihood of progression to cirrhosis and liver-related clinical events. Because ELF™ uses a blood sample rather than a biopsy, it can be used routinely for the same patient over time.
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Test: 403604
FIB-4 index is reported to be a simple, accurate, non-invasive, and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications. It was also reported to be concordant with FibroSure test results.
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Test: 402070
FIB-4 index is reported to be a simple, accurate, non-invasive, and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications.
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Test: 402145
Screening patients suspected to be at risk for liver fibrosis. AST to Platelet Ratio Index (APRI) is reported to be a simple, noninvasive, and readily available laboratory test index that can stratify patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) who are at high or low risk for significant fibrosis and cirrhosis with high degree of accurancy. FIB-4 index is reported to be a simple, accurate, noninvasive, and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications.
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Test: 550140
This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD). Quantitative results of 10 biochemicals in combination with age, gender, height, and weight are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.38) precludes the diagnosis of NASH.
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Test: 550960
NASH FibroSure Plus® offers a more streamlined testing process than NASH FibroSure: BMI is no longer included in the calculation, eliminating one step for providers.
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Test: 504960
Utilizing NIS4™ technology, NASHnext™ is a blood-based diagnostic test that quantitatively measures four independent biomarkers to produce a score that identifies, among patients with metabolic factors, those with at-risk NASH, who are at higher risk of disease progression.
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Test: 402205
The cascade is intended for use in patients with non-alcoholic fatty liver disease (NAFLD) and suspected non-alcoholic steatohepatitis (NASH) with advanced fibrosis that include subjects with no alcohol-related disorders and any of the following: elevated liver function tests, obesity, type 2 diabetes, metabolic syndrome, imaging evidence of fat accumulation, dyslipidemia, polycystic ovary syndrome. These patients may be at high risk for progression to advanced liver fibrosis that can cause a fast progression to end-stage liver disease, hepatocellular carcinoma, and liver transplantation. Non-invasive blood biomarkers can help identifying those patients using rule-out approach. Liver biopsy is still required to definitively diagnose patients with NASH and NASH fibrosis.
More accurate results. Fewer invasive procedures. Better outcomes.
In addition to diagnostic tests that aim to identify NASH and NAFLD, Labcorp can provide you and your patients with testing that can help identify underlying NASH and NAFLD risks. From hepatitis to cardiovascular disease, Labcorp can assist with your diagnostic testing needs.
Risk of Cardiovascular Disease and Type 2 Diabetes
Liver-Related Markers
ASH Testing
| Number | Name |
|---|---|
| 550180 | ASH FibroSure® |
| 737610 | Ethyl Glucuronide/Ethyl Sulfate (EtG/EtS), Screen and Confirmation, Urine |