Metabolomic Biomarker of Altered Hepatic FunctionTechnology #ua08-019
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Title: Metabolomic Biomarker of Altered Hepatic Function
Invention: We have developed a metabolomic biomarker that clearly delineates patients with steatosis that have a normal metabolism rate from patients with steatohepatitis and the resulting decreased capacity to metabolize and eliminate drugs. We are in the process of determining whether the test can be conducted simply with urine samples or whether a blood test is necessary.
Background: It is estimated that approximately 60 million Americans have some form of fatty liver disease, with 6 million having progressed to the inflammatory liver disease, steatohepatitis. Of those 6 million, only ~ 92 thousand have been properly diagnosed. This is due to the difficulty in diagnosis, where only an invasive needle biopsy can discriminate from the rather benign form, steatosis. Importantly, patients who have progressed to steatohepatitis are at much greater risk for adverse drug reactions and other complications due to the alterations in drug metabolizing enzymes and transporters.
It has been estimated that adverse drug reactions are among the leading causes of death in the US (between 4th and 6th) at a cost of $177.4 billion (2000). Although genetics may play a role in expression of major drug metabolizing enzymes, it is estimated that genetics is involved in less than 20% of all adverse drug reactions meaning that the vast majority of causes are due to environmental factors such as disease.
Because the liver plays a major role in determining the rate at which drugs are eliminated, any condition that impairs liver function is an important factor in predicting adverse drug reactions. Unfortunately, the methods currently available to determine the condition of a patient’s liver are imperfect at best. The only test that measures the extent of liver damage associated with altered metabolism is an invasive needle biopsy and the requirements of this test are such that it is impractical to put it into widespread use. Currently there is no biomarker available to accurately stage a patient’s progression to steatohepatitis or determine an individual patient’s capacity to metabolize and eliminate drugs.
This assay can be used as a staging diagnostic tool to determine whether patients have progressed to an inflammatory stage of liver disease
This assay detects patients with impaired ability to eliminate drugs from their bodies. These patients are more likely to be susceptible to adverse drug reactions.
This is the only test that directly measures a patient’s capacity to metabolize and eliminate drugs.
The test is simple enough to be used widely and routinely.