FDA Clears Hepatiq Software for Quantifying Liver Disease

Megan Brooks

Disclosures

January 12, 2015

The US Food and Drug Administration (FDA) has approved software designed to help determine the severity of liver disease by quantitative analysis of nuclear medicine liver-spleen images.

The Hepatiq software, from Hepatiq LLC, calculates perfused hepatic mass, a measure of liver function.

The software automates the quantitative liver spleen scan shown to be an accurate predictor of clinical outcomes in the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis trial, the company explains in a news release.

John Hoefs, MD, cofounder and chief operating officer of the company, developed the quantitative liver spleen scan methods to measure hepatic function, fibrosis, hepatic and spleen volume, and cirrhosis, whereas Dipu Ghosh, the company's chief executive officer, created the algorithms for automating the quantitative liver spleen scan techniques.

"As hepatologists," Dr Hoefs commented in the release, "we have needed and searched for a reliable, precise method of measuring liver function that can be used in the clinical setting. Hepatic function is more important than hepatic fibrosis as hepatic function determines both the likelihood of clinical problems and patient survival. We are very excited that this method will now be available to physicians and patients."

About 15% of adults globally have chronic liver disease. In the United States, about 32,000 people die each year from liver disease, the company notes.

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