Drug & Device Development

Biomarker combination may noninvasively diagnose cirrhosis

Last Updated: 2004-03-12 13:10:23 -0400 (Reuters Health)

NEW YORK (Reuters Health) - In patients with liver disease, a new technique for analyzing profiles of serum protein N-glycans may obviate the need for liver biopsy to diagnose cirrhosis. The approach, referred to by its developers as "clinical glycomics" technology, is described in the March 7th online edition of Nature Medicine.

Dr. Nico Callewaert of Ghent University, Belgium and colleagues found that the combined use of this new set of biomarkers along with an older one makes it possible to diagnosis cirrhosis with 100% specificity and far higher sensitivity than had been possible with existing techniques. The marker combination, they note "did not yield any false positives among patients who were liver biopsy candidates, and the sensitivity of detection was 75% for compensated cirrhosis and 100% for decompensated cases."

The older set of biomarkers, called FibroTest, is a surrogate marker of liver fibrosis that is based on analysis of alpha2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin and gamma glutamyl transpeptidase. The newer set, GlycoCirrhoTest, is derived from DNA sequencer-based profiling of serum protein N-glycans.

GlycoCirrhoTest distinguishes patients with compensated cirrhosis from patients with noncirrhotic chronic liver disease "by measuring just two easily detectable peaks" in the profile, according to the investigators. GlycoCirrhoTest results also correlate strongly with fibrosis stage.

As well as obviating the need for biopsy in many patients, the use of the combination of tests, the researchers conclude, "could be of considerable importance in monitoring the progression of chronic liver disease." Furthermore, "regular application would yield a warning signal for cirrhosis-related, life-threatening complications."

Nature Medicine 2004: