IRVINE, Calif., July 12, 2016 /PRNewswire/ -- HEPATIQ LLC announced that they received clearance from the U.S. Food and Drug Administration to add two additional indices of liver disease severity to their product. HEPATIQ now includes fSV (an index of splenic volume and portal hypertension) and fLV (an index of functional hepatic volume) in addition to the previously cleared PHM index to provide a comprehensive liver test that outperforms blood tests and biopsies in predicting clinical outcomes.
In the prospective 7-year multi-center HALT-C trial, the baseline PHM and fSV indices were shown to correlate with future adverse clinical outcomes. On the other hand, the same trial showed that baseline routine blood tests such as bilirubin, INR and albumin were within normal range in most patients who subsequently developed clinical outcomes.
The HALT-C trial also showed that the PHM and fSV indices may be superior to histological staging by liver biopsy in identifying both high- and low-risk groups and may be more accurate than staging fibrosis in predicting clinical outcomes.
"We are delighted to receive this additional clearance from the FDA in only 6 weeks," said Dipu Ghosh, CEO of HEPATIQ LLC. "The company is also very encouraged by the tremendous reception for our product at the recently concluded DDW and SNMMI conferences."
"The PHM measure of hepatic function correlates closely with the functional mass of the liver rationalizing the close correlation with complications of chronic liver disease in the HALT-C trial and should also correlate with tolerance of surgery," said Dr. John Hoefs, COO of HEPATIQ LLC. "Hepatic fibrosis by contrast is a less precise correlate of hepatic function and, therefore, less effective," concluded Dr. Hoefs.
HEPATIQ LLC is focused on diagnosing the severity of liver disease and predicting adverse clinical outcomes. Chronic liver disease is a slow and silent killer. It is widespread with about 15% prevalence globally. About 32,000 people die each year in the US from liver disease. For more information, please visit www.hepatiq.com.
HEPATIQ, PHM, fSV and fLV are trademarks of HEPATIQ LLC.
This press release contains forward-looking statements. These are based on current expectations and beliefs and are subject to numerous risks, uncertainties and change. The parties disclaim any obligation to update any forward-looking statement as a result of developments occurring after this release.
PRLog ID: www.prlog.org/12572068
SOURCE HEPATIQ LLC