BURLINGTON, N.C.– For the millions of people in the United States living with an advanced form of chronic liver disease, simply understanding the potential for future complications could help stave off severe damage and even a transplant. Labcorp (NYSE: LH), a leading global life sciences company, is making this possible by offering the Enhanced Liver Fibrosis (ELF™) test. Developed by Siemens Healthineers, the physician-ordered blood test helps assess the risk of disease progression in individuals—opening the door for improved outcomes. The test has been granted De Novo marketing authorization by the U.S. Food and Drug Administration.
The ELF test provides a numeric score to people with advanced liver fibrosis caused by nonalcoholic steatohepatitis (NASH), a type of nonalcoholic fatty liver disease (NAFLD) often tied to obesity and diabetes. That score is combined with additional evaluations and test results to determine the likelihood of late-stage liver scarring and other serious conditions.
“Because NASH is typically addressed through lifestyle shifts such as weight loss and frequent exercise, knowing your risk of more severe damage can help you make the right changes at the right time,” said Dr. Marcia Eisenberg, chief scientific officer of Labcorp Diagnostics. “The ELF test gives doctors and patients important information that can factor into the assessment of treatment options. Adding it to Labcorp’s robust suite of NASH-focused tests furthers our commitment to fighting chronic liver disease and to our overarching goal to improve health and improve lives.”
NAFLD is the collective term for conditions involving excess fat accumulation in the liver not caused by alcohol use. These range from a condition called “fatty liver,” to the more serious condition known as NASH. Through liver cell injury and inflammation from fatty buildup, NASH-caused advanced fibrosis can increase liver-related morbidity and mortality if left unchecked.
There is currently no standard treatment for NASH beyond exercise and other lifestyle modifications. Oftentimes, people living with NASH don’t know it, as symptoms can be difficult to recognize. This creates a challenge for patients and providers, and it has led many health experts to refer to the disease as a silent epidemic. Recent estimates suggest approximately 20 million people in the U.S. have NASH. The prevalence of the disease is expected to increase in the next several years, resulting in a growing, unmet medical need.
Proper and widely available diagnostic and prognostic testing is required to identify NAFLD and NASH cases and high-risk patients, help slow disease progression and create a brighter future for those living with this potentially deadly condition. Labcorp has devoted significant resources to developing its strong NASH testing portfolio, which includes tests for assessing a patient’s liver status such as NASH FibroSure®, NASH FibroSure® Plus and NASHnext™.
Additionally, the company continues to harness its leading diagnostic and drug development capabilities to improve the public’s understanding of NASH, help advance new treatments and promote broad access to clinical trials.