Owlstone Medical recently announced the success of its patient study demonstrating its Breath Biopsy®, using limonene as a biomarker in measuring liver function.
The study demonstrated how exhaled limonene, a natural compound found in oranges and lemons, can be used as a breath biomarker when measuring liver function.
About the Study
Researchers analyzed exhaled breath from thirty-two patients with cirrhosis and twelve patients with cirrhotic hepatocellular-carcinoma. Results from those analyses were compared against forty controls.
The end results showed a sensitivity of 73% and 77%. Sensitivity classifies a person as sick or diseased. Specificity classifies that person as being healthy and free of disease.
The tests were evidence that levels of limonene were clearly associated with changes in liver function.
The encouraging results of the study give weight to Owlstone’s EVOC® probe strategy of using breath-based tests for nonalcoholic steatohepatitis (NASH), and nonalcoholic fatty liver disease (NAFLD).
The original article was published in Clinical and Translational Gastroenterology.
NAFLD and NASH
People who drink a moderate amount of alcohol or those who do not drink alcohol may develop NAFLD. It is a condition that involves fat accumulation in the liver. The number of cases has also increased due to obesity but there are other underlying issues that may cause the disease.
In addition to obesity, some of the risk factors that may cause NAFLD include: type 2 diabetes, dyslipidaemia (excess lipids in the blood), metabolic syndrome, polycystic ovary syndrome, age, gender, and ethnicity.
NAFLD is generally asymptomatic. A segment of the population who develop NAFLD may develop NASH, a more aggressive disease. NASH patients may experience liver inflammation and eventually cirrhosis (scarring) or liver failure. The damage caused by NASH mimics that caused by alcohol abuse as it affects a patient’s cardiovascular condition.
Filling a Need
Although articles on “eating healthy” appear in our news each day, the world is still faced with epidemics of diabetes and obesity. Estimates of NAFLD are at twenty-five percent. Up to six percent of these cases will progress to NASH.
Researchers are aware that preventing deaths from liver disease depends on early detection. But in many cases (about 75%) symptoms do not appear until the disease has progressed.
Early detection may now be achieved with Breath Biopsy which measures volatile organic compounds (VOCs) rapidly and non-invasively. This new type of measurement captures the chemical makeup of breath by way of the VOCs. The exhaled VOCs are gaseous molecules that travel through the bloodstream allowing whole body monitoring.
The Breath Biopsy applies to such diseases as cancer, metabolic disease, inflammatory disease, cardiovascular disease, and respiratory diseases.
The new tests will be offered to pharma companies that are developing NAFLD/NASH drugs.
About Liver Function Tests
Currently, a liver biopsy is the most relied-upon test of liver disease. The test, however, is costly and invasive. It does not adapt well to screening. Other tests for liver function are blood-based and used to detect a wide range of diseases.
Doctors face the challenge of diagnosing NAFLD before it evolves into NASH and becomes irreversible. At that stage, doctors have few options other than trying to delay further progression and address the symptoms.
Owlstone’s CEO, Billy Boyle, stated that the company has a number of compounds that are being considered as EVOC probes for liver disease. In the future, he hopes to apply EVOC to other areas that will include earlier and improved diagnoses of lung cancer.