Labcorp to Offer Risk-Scoring Test for People With Advanced Liver Fibrosis Due to NASH

Rhea-AI Summary

Labcorp has launched the Enhanced Liver Fibrosis (ELF™) test, aiming to assess the risk of disease progression in patients with advanced chronic liver disease. This blood test, developed by Siemens Healthineers, has received De Novo marketing authorization from the FDA. It provides a numeric score for patients suffering from nonalcoholic steatohepatitis (NASH), enabling better treatment decisions. Approximately 20 million Americans are affected by NASH, highlighting an urgent need for improved diagnostics in this silent epidemic.

Positive

• Launch of the Enhanced Liver Fibrosis (ELF™) test enhances Labcorp's diagnostic offerings for nonalcoholic fatty liver disease.
• FDA granted De Novo marketing authorization for the ELF test.
• The test aids in assessing risk for disease progression, helping in timely treatment decisions.

Negative

• NASH lacks standard treatment options beyond lifestyle changes.
• An estimated 20 million people in the U.S. have NASH, indicating a significant unmet medical need.

Enhanced Liver Fibrosis (ELF™) Test Gauges Likelihood of Disease Progression; Expands Labcorp’s Testing Options for Nonalcoholic Fatty Liver Disease

BURLINGTON, N.C.--(BUSINESS WIRE)-- 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.

Photo courtesy of Labcorp

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.

For more information on Labcorp’s efforts to combat NASH, visit www.labcorp.com/nash. Additional information on the physician-ordered ELF test can be found at www.labcorp.com/nash-testing.

About Labcorp

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $14 billion in FY2020. Learn more about us at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220126005573/en/

Labcorp Contacts:

Media: Michele Mazur — 336-436-8263

Media@Labcorp.com

Investors: Chas Cook — 336-436-5076

Investor@Labcorp.com

Source: Labcorp

FAQ

What is the Enhanced Liver Fibrosis (ELF™) test by Labcorp?

The ELF™ test is a blood test designed to assess the risk of disease progression in patients with advanced chronic liver disease, particularly nonalcoholic steatohepatitis (NASH).

What company developed the ELF test?

The ELF test was developed by Siemens Healthineers.

When did Labcorp receive FDA authorization for the ELF test?

Labcorp received De Novo marketing authorization from the FDA for the ELF test.

How many people in the U.S. are affected by NASH?

Approximately 20 million people in the U.S. are estimated to have nonalcoholic steatohepatitis (NASH).

What is Labcorp's stock symbol?

Labcorp's stock symbol is LH.