Liver Fibrosis Assay for HCV Patients

Liver biopsy has been considered the gold standard for monitoring the status of HCV and determining therapy options, but it is an invasive procedure that can result in serious complications.

The new test, called HCV FibroSURE, uses a combination of six serum biochemical markers plus age and gender in a patented algorithm to determine the degree of liver fibrosis and the level of ongoing necroinflammatory activity. The test has been shown in several studies to enable quantitative, reproducible assessment of fibrogenic and necrotic activity in the liver of HCV patients. The test has been available in Europe for the past two years, and is now available in the United States solely through Laboratory Corporation of America, known as LabCorp (Burlington, NC, USA; www.labcorp.com).

"The launch of this important new test once again validates LabCorp's strategy of creating a world-class national laboratory with the best and broadest array of diagnostic testing services,” said Myla P. Lai-Goldman, M.D., executive vice president, chief scientific officer, and medical director at LabCorp.

The test was developed by leading hepatologists at the Pitie-Salpetriere Hospital and BioPredictive (both in Paris, France). Founded at Paris University in 2002, BioPredictive is focused on the study, design, and development of medically important biologic tests. The company's efforts are focused on replacing invasive strategies with noninvasive strategies.

BioPredictive has actually developed two noninvasive tests for chronic liver disease: FibroTest and ActiTest. FibroTest is a biochemical marker of liver fibrosis, while ActiTest is a biochemical marker of inflammation and necrosis of the liver. BioPredictive licenses the FibroTest and ActiTest technology from the Assistance Public Hospital in Paris (France). Both are available under the name HCV FibroSURE.

HCV FibroSURE is recommended for use in assessing liver status following a diagnosis of HCV, as a baseline determination of liver status prior to initiating HCV therapy, as post-treatment assessment of liver status six months after therapy completion, and for noninvasive assessment of liver status in patients at risk of complications from a liver biopsy. The blood sample for HCV FibroSURE can be collected in minutes, and results can be returned to the doctor within days. The six biochemical markers used are routine.

BioPredictive is currently researching the clinical use of this test for other diseases, including hepatitis B, HIV-HCV, and alcoholic and nonalcoholic steato-hepatitis (NASH). "We anticipate that HCV FibroSURE will prove to be just the first in a family of innovative, noninvasive diagnostic testing products aimed at hepatitis and nonhepatitis-related conditions,” said Dr. Thierry Poynard, head of the hepato-gastroenterology department in Pitie-Salpetriere Hospital and founder of BioPredictive.




Related Links:
Lab Corps
BioPredictive
Pitie-Salpetriere Hospital