Alternative to Liver Biopsy for HCV Patients

French scientists have developed two noninvasive blood tests for assessing the extent of liver disease in patients with hepatitis C virus (HCV), replacing the liver biopsy currently used to assess liver fibrosis and necroinflammatory activity in these patients.

While liver biopsy has long been considered the gold standard for monitoring the status of HCV and to determine therapy options, it remains an invasive procedure with a risk of serious complications. The new twin assays, FibroTest and ActiTest, use a combination of six biochemical serum markers, plus age and gender data, in a patented algorithm to determine the degree of liver fibrosis and necroinflammatory activity. Both tests have been clinically validated in HCV patients. The blood sample can be collected in minutes and results returned to the doctor within days.

"When biotechnology companies need a clinical laboratory partner, they look for a company with a proven business strategy, as well as scientific and technologic expertise,” noted Dr. Thierry Poynard, head of the hepato-gastroenterology department in Pitie-Salpetriere Hospital (Paris, France), researcher, and founder of Biopredictive (also in Paris). The new tests were developed by scientists at Pitie-Salpetriere Hospital and BioPredictive, founded in 2002 at the University of Paris.

The tests are available in the United Kingdom and Ireland only through Oneida TheraDiagnostics (London, UK), a recently established company offering molecular diagnostic services for clinical studies with particular emphasis on viral disease. "The tests launched today are very well validated and address one of the major challenges in patients with chronic viral hepatitis,” said Berwyn Clarke, cofounder and CEO at Oneida. "They will be the cornerstone of our viral hepatitis diagnostic service.”





Related Links:
BioPredictive
Oneida