Tel Aviv University Develops Basis For World’s First Reliable Non-Invasive Liver Disease Test

Hepatitis B and C are insidious diseases that if left untreated can slowly lead to liver dysfunction and failure. Until now, the only known clear-cut method for determining liver disease severity is through a painful liver biopsy – conducted only once or twice in a patient’s lifetime.

This month Tel Aviv University (TAU) researchers have announced a discovery that will take the guesswork out of liver disease progression: researchers Professor Gerardo Z. Lederkremer and Maria Kondratyev from the Department of Cell Research and Immunology have discovered a biomarker circulating in our blood that can be correlated to liver fibrosis — the deterioration of liver cells due to a diseased organ.

Unlike a risky and painful biopsy procedure that can lead to infection and other undesirable effects, this biomarker known as soluble human asialoglycoprotein receptor (ASGPR), can be measured from a simple blood test. It can tell a doctor with high accuracy to what stage liver disease and damage has progressed.

Biomarkers are proteins that can be measured in the blood and can be linked to a specific disease before symptoms manifest. In the case of liver disease, unhealthy people are found to have much less ASGPR in their blood.

According to the American Liver Foundation (ALF), some 30 million Americans are affected by liver disease. It is a complication resulting from hepatitis B and C infection; it is also caused by alcoholism and obesity – a growing concern.

Prof. Lederkremer points to literature reporting that 30 percent of Americans have a new heath scare in the form of a condition known as “fatty liver”.

“Fatty liver,” reports the ALF website, “is a little known condition that is connected with obesity. It can lead to nonalcoholic steatohepatitis (NASH), which can lead to cirrhosis and liver failure. In fact, NASH is one of the top causes of cirrhosis in the country.”

The new TAU test, researchers believe, will be able to help inform and educate people as to the health of their liver from the first sign of abnormality. If a person knows their liver is affected, and in early stages of liver disease, they can take action by correcting their diet or by taking the proper medication.

This is good news for hepatitis B and C carriers – together more than 2 billion people worldwide - who go on living with the viral infection not knowing how it will affect liver functioning in the future.

The new diagnostic marker is currently being studied on hepatitis B and C patients (about 200 people) at Tel Aviv’s Ichilov General Hospital where Lederkremer and associates, Dr. Yoav Luria, head of the hospital’s Liver Unit, are correlating liver biopsies to biomarker presence in the blood.

“We are offering a non-invasive procedure which is appropriate for both early and late stage liver fibrosis and cirrhosis,” says Nissim Chen, Director of Business Development in Life Sciences at Ramot - TAU's commercial arm. He continues, “Doctors want to know early on if a patient has fibrosis to know how it should be treated.”

If left untreated, liver disease can lead to fatal diseases such as cancer and cirrhosis.

Not only is the new biomarker test important for monitoring liver fibrosis of hepatitis sufferers, it is expected to be a safe and painless way for doctors to monitor liver recovery during therapy of patients and liver transplants. “This will help their treatment and success,” added Nissim, who says there will be a certain market for it as well to aid doctors in determining liver damage due to alcoholism.

Until now, the biomarker has never been revealed or used, says Lederkremer, who came to the idea through basic research of proteins in cell biology.

Ramot is currently negotiating to commercialize the technology suited to a large diagnostics company with an existing portfolio of diagnostic tests. Because clinical studies in the area of diagnostics compared to therapeutics are less rigorous, Americans can expect the biomarker in the form of a diagnostic kit to be available within one to two years.