Thursday, May 28, 2015

Large prevalence of liver disease spawns race for better testing

As drugmakers develop new medicines to battle liver disease epidemic, they have created an urgent need for better diagnostics to select patients for treatment and assess their drugs' effectiveness.

About 30 percent of people in the U.S. now suffer from fatty liver diseases, such as NASH (nonalcoholic steatohepatitis), fueled by obesity, diabetes and over-indulgent lifestyles, according to the American Liver Foundation. Without treatment, sufferers can develop advanced damage, including the scarring known as fibrosis; cirrhosis, which destroys liver function; and even cancer.

For now, testing patients in trials of experimental medicines involves a liver biopsy, a painful, expensive and potentially risky test. Its accuracy is also limited as it draws just a tiny piece of the liver, which may not be affected uniformly by disease.

It's a pretty nasty test involving a needle five inches long you plunge blindly into a patient's side. Researchers don't like to do them. As they can't do more than one at the beginning, one at the end (of a trial). So there's this frantic effort now to develop (diagnostics) that will give us the information necessary to know if a drug is working.

More than a dozen drugmakers are working on new treatments for liver disease. They will find eager partners in several small companies, often spawned from academic or hospital research, which are working on alternatives to liver biopsy.

Some of the new techniques use MRI scans that view the entire liver. Others involve blood tests to measure liver scarring or function. One diagnostic evaluates liver damage via exhaled breath. They could replace biopsy or be used to provide interim results during lengthy studies.

New diagnostics will also help U.S. health insurers determine which patients are most in need of treatment to keep a closer watch on cost.


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