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New Blood Test Biopsy Alternative

October 9, 2004

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A while back I wrote about a biopsy alternative called Fibrospect.

Here is yet another blood test based alternative that has been used successfully in Europe for a couple of years and is now available in the USA. While biopsies are not considered dangerous, they are not without risk. To have a dependable, non-invasive alternative is valuable.

Your gastro may not have the latest information always available to them so it could be helpful for you to bring this up for discussion if a liver biopsy is recommended.

Blood Tests Provide Alternative to Liver Biopsy for Assessing Status of Liver Disease in HCV Patients

Oneida TheraDiagnostics Ltd has launched two non-invasive blood tests for assessing the extent of liver disease in patients infected with hepatitis C virus (HCV). Developed by hepatologists at the Pitie-Salpetriere Hospital and BioPredictive in France, the two tests are called FibroTest and ActiTest.

The new tests provide easily accessible alternatives to liver biopsy, which is currently used to assess liver fibrosis and necroinflammatory activity in these patients. The tests do not replace the use of liver biopsy, however, which may be the appropriate diagnostic in many cases. Whether to use these new blood tests instead of a liver biopsy should be discussed between each individual patient and his/her primary care physician or liver specialist.

Although liver biopsy has long been considered the gold standard for monitoring the status of HCV and to determine therapy options, it is an invasive procedure that carries some risk of serious complications. The new assays use a combination of six serum biochemical markers, plus age and gender data, in a patented algorithm to determine the degree of liver fibrosis and the level of ongoing necroinflammatory activity.

The tests have been available in parts of Europe for the past two years and have recently been launched in the USA. Each test has been clinically validated in HCV patients to enable quantitative, reproducible assessment of fibrogenic and necrotic activity in the livers of HCV patients.

Oneida TheraDiagnostics Ltd. is a recently established company based in the UK offering molecular diagnostic services for clinical studies with particular emphasis on viral disease.

“Our intention is to establish a world-class portfolio of molecular diagnostics that will facilitate individual patient management and clinical trial studies performed in the UK and Ireland. The tests launched today are very well validated and address one of the major challenges in patients with chronic viral hepatitis. They will be the cornerstone of our viral hepatitis diagnostic service,” said Berwyn Clarke, CEO at Oneida.

FibroTest and ActiTest may be recommended by physicians for use in assessing liver status following a diagnosis of HCV. This provides a baseline determination of liver status before the initiation of HCV therapy and a post-treatment assessment of liver status six months after the completion of therapy.

The tests can also be applied for the non-invasive assessment of liver status in patients at risk of complications from a liver biopsy. The blood sample for the tests can be collected in minutes and results normally returned to the doctor within days.

Source
Oneida TheraDiagnostics. www.oneidathd.co.uk “Validated blood tests provide new alternative to liver biopsy for assessing status of liver disease in hepatitis C patients.” Press Release. October 8, 2004.

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