Resonance Health develops accurate fatty liver diagnostic test, seeks FDA approval
Resonance Health (ASX: RHT) has developed a fatty liver diagnostic test after positive results from a clinical study accurately assessed the severity of the disease.
Results from the clinical study demonstrate that the MRI-based diagnostic product developed by the company can accurately assess the severity of fatty liver disease, replacing the costly and time-consuming need for an invasive liver biopsy.
The company has begun preparation of a Food and Drug Administration submission to gain regulatory approval for the product.
The clinical study involved 46 subjects with liver disease, including non-alcoholic fatty liver disease, non-alcoholic steatohepatitis and Hepatitis C.
Each patient underwent a liver biopsy with the degree of liver fat scored by two independent methods and compared to the MRI-based result, showing a high level of sensitivity and specificity for the test.
According to Resonance, nearly one in three Americans have fatty liver, and non-alcoholic fatty liver disease is the most common liver disease in the US and Europe.
An accurate diagnosis of early stage fatty liver disease provides a better outcome for patients, to address the condition before the onset of liver damage.














