The HEPATIQ® software provides quantitative liver function by analyzing images from a nuclear medicine scan. The test takes about an hour and the scan is covered by insurance. The HEPATIQ software is cleared for sale by the U.S. Food and Drug Administration. To our knowledge, there is currently no other product on the market that provides quantitative liver function.
Originally, definitive liver disease diagnosis was largely reliant upon an invasive biopsy. Since about 2005, non-invasive elastography has become available. Elastography measures the amount of fibrosis or scarring in the liver (white areas in figure). However, physicians are now increasingly aware of the limitations of fibrosis measurements. A recent study of 800,000 individuals published in Gastroenterology showed that fibrosis scoring has modest predictive value. Another study published in the Journal of Clinical Gastroenterology showed that fibrosis scores don't do a good job with diabetics.
The reason fibrosis measurements lack strong predictive power is because liver disease outcomes are driven by the residual quantitative liver function, not the extent of fibrosis. This was established in the prestigious multi-center 8 year NIH funded HALT-C trial, which concluded that quantitative liver function may be more accurate than staging fibrosis in predicting clinical outcomes. Thus, with the limitations of fibrosis becoming evident, and quantitative liver function now available with the HEPATIQ software, we may be at a turning point in the management of liver disease.
To use a car analogy, fibrosis is akin to the amount of air in the gas tank, while quantitative function is the amount of gas in the tank. To know how far the car will go, one needs to measure the amount of gas in the tank, not the amount of air. To predict how a patient with liver disease will fare, one needs quantitative liver function, not the extent of fibrosis.
We now have several medical centers using the HEPATIQ software in routine clinical practice for the diagnosis, staging and management of chronic liver disease, while other centers are using it to conduct further research. If you are interested in using the HEPATIQ software, please contact us at sales@hepatiq.com.
