Doctors have discovered a less invasive way of diagnosing disease in the liver, a method that has the potential to save lives and money, according to a study led by a Virginia Commonwealth University professor.
To diagnose the most advanced type of nonalcoholic fatty liver disease, a doctor must insert a needle through the patient’s abdomen and into the liver, a procedure known as a biopsy. But the new study indicates that the degree of disease can be determined by a blood test, which is cheaper and much easier to perform.
If the blood tests are approved by regulators, they could change how liver disease is diagnosed in millions of Americans. Roughly one in three people has excess fat in the liver, a risk factor that could eventually lead to permanent scarring of the 3-pound organ, known as cirrhosis, or cancer.
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“It’s not feasible to stab 100 million livers,” said Dr. Arun Sanyal, director of VCU’s Stravitz-Sanyal Institute of Liver Disease and Metabolic Health and the study’s leader.
The results were announced last week and published in the journal Nature Medicine.
Of the roughly 100 million patients who have excess fat in their livers, about one in five develops a more advanced disease that can lead to cirrhosis or cancer. The more advanced disease is referred to either as NASH (nonalcoholic steatohepatitis) or MASH (metabolic dysfunction-associated steatohepatitis). It’s estimated between 5 million and 10 million people have the more advanced disease, and that number is expected to grow as the population ages.
Nonalcoholic liver disease is often caused by obesity, Type 2 diabetes or genetic factors. It can spread for 10 or 20 years until the first symptom is discovered. By the time the patient has developed cirrhosis, transplantation may be necessary.
But transplantation isn’t the answer for treating this disease, said Sanyal, who led the study as part of the Foundation for the National Institutes of Health Biomarkers Consortium. Available organs are scarce, recipients must be otherwise healthy to qualify, and transplantation requires medication for the rest of a patient’s life.
To test for the disease, doctors must conduct a biopsy. After the patient is anesthetized with Novocain, the doctor inserts a needle through the skin and into the liver, extracting tissue. The procedure takes several hours, carries some risk and costs about $2,000.
“It’s nothing anyone is excited about getting done,” Sanyal said.
A blood test, however, is far less invasive. Blood is drawn from the patient’s arm, and the procedure can be conducted in a primary care setting. More doctors could diagnose the disease, and the procedure would cost $200 or less.
Pharmaceutical companies have tried to develop similar blood tests before but never gained approval. The new tests, the researchers say, appear to have succeeded where previous attempts failed. Four of the five biomarkers developed in this study performed better than current blood-based lab tests. Researchers tested the biomarkers on roughly 1,000 study participants.
If the blood tests are approved and become mainstream, people with risk factors could be tested preventatively in hopes of catching the disease before it wreaks havoc on the body. Currently, there are no approved medications to treat MASH, but Sanyal said they could arrive soon. The new blood tests should encourage more research on drug therapies for liver disease, and they will enable more patients to participate in trials.
Some liver disease is caused by alcohol consumption, and Sanyal’s group did not include these patients in their study. The alcohol-induced version of the disease tends to arise earlier in life — often in patients in their 20s and 30s — and disproportionately affects women. And it tends not to affect other organs the way the nonalcoholic version does.
But Sanyal believes the blood tests eventually could be used for people with the alcohol-caused version of the disease.
The blood tests still need approval from the Food and Drug Administration, a process that often takes years. But his group is already preparing to seek approval.
“We can see the goalposts,” he said.