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Validated blood tests provide new alternative to liver biopsy for assessing status of liver disease in hepatitis C patients London, England, 4
October 2004 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 twin assays – FibroTestTM and ActiTestTM
are available in the UK and Ireland only through Oneida TheraDiagnostics. The
new tests provide easily accessible alternatives to liver biopsy, which is
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 is an invasive procedure that
carries a 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, co-founder and CEO at Oneida. “We are confident
that there will be significant interest from the private and public sectors
within the UK and Ireland, since these assays not only alleviate the requirement
for invasive procedures but also provide considerable cost-benefits to service
providers.” “When
biotechnology companies need a clinical laboratory partner, they look for a
company with a proven business strategy, as well as scientific and technological
expertise,” commented Dr. Thierry Poynard, a
world-renowned hepatologist, head of Hepato-Gastrotroenterology department in
Pitie-Salpetriere Hospital in Paris, researcher and founder of BioPredictive. “We
are excited to be working with Oneida TheraDiagnostics because they are a
dynamic company with particular emphasis on viral disease and a keen
understanding of the importance of new technology to improve the management of
HCV patients.” FibroTestTM
and ActiTestTM are
recommended 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.
www.oneidathd.co.uk About Oneida
TheraDiagnostics Founded
in 2003 Oneida TheraDiagnostics Limited aims to provide a Molecular Diagnostic
Reference service that combines a full spectrum of analytic capability
specialising in the virology field but with broader application across other
therapeutic areas. The core business of the company is the provision of
molecular services to facilitate individual patient management and to support
clinical trials in diverse therapeutic areas. In parallel with the service
business, the Company also has specific interests and expertise in antiviral
drug resistance. This is linked to
a new antiviral drug discovery programme that focuses specifically on drug
resistant human immunodeficiency virus (HIV) and hepatitis C virus (HCV).
This programme will use the reagents, IP and revenues from the service
business, together with IP from key chemistry partners. The Company has also
secured exclusive rights to key diagnostic procedures within and outside the
virology area. About
BioPredictive Founded
at Paris University in 2002, BioPredictive is focused on the study, design and
development of medically important biological tests. At the centre of the
scientific efforts of the Company is the desire to improve disease management by
replacing invasive strategies with non-invasive alternatives. BioPredictive has
developed two non-invasive tests for chronic liver disease - FibroTest and
ActiTest. FibroTest is a biochemical marker of liver fibrosis and ActiTest is a
biochemical marker of inflammation and necrosis of the liver. BioPredictive
licenses the FibroTest and ActiTest technology from Assistance Public-Hopitaux
de Paris (AP-HP). The company performs more than 3,000 tests per month, and
services over 150 private and 20 public hospital laboratories in France,
Belgium, Germany, Switzerland, Portugal, Turkey, Egypt, Morocco, Brazil, Mexico
and USA. To learn more about BioPredictive, visit the company Web site at: www.BioPredictive.com
Company contact:
Press contact: Berwyn
Clarke
Richard Kent Oneida
TheraDiagnostics Limited
Kapler Communications Ltd London
Biosciences Innovation Centre Cressner
House, 12 Huntingdon Street London,
NW1 0TU
St Neots, Cambs, PE19 1BD Tel:
+44 (0) 77 6969 8686
Tel: +44 (0) 1480 471860 Email:
bclarke@oneidathd.co.uk
Email: richard@kapleronline.com
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