-- Amorfix Demonstrates vCJD Test Can Be Used Routinely to Test Blood
TORONTO, Jan. 13 /CNW/ - Amorfix Life Sciences, a company focused on
treatments and diagnostics for brain wasting diseases, today announced it has
tested 10,000 blood donations in France using its EP-vCJD(TM) test as part of
a large-scale study to demonstrate the feasibility of routine testing of blood
donations for vCJD.
"France has taken a leading role in assessing the feasibility of testing
routine blood donations for vCJD by establishing the Amorfix test in a major
blood transfusion centre. Based on the 99.94% specificity achieved in this
large-scale independent testing of 10,000 samples, and the 100% sensitivity at
1:1,000,000 dilution of vCJD brain in the UK validation panel, the Amorfix
test has demonstrated its readiness for use by high-risk nations to conduct
prevalence studies to assess the safety of their blood supply," said Dr.
George Adams, Chief Executive Officer of Amorfix.
The 10,000 blood samples were collected using standard procedures from
routine blood donors, and anonymously tested for vCJD by staff at the
EFS-Alsace Blood Transfusion Centre in Strasbourg, France. Six blood samples
were repeat positive, consistent with a specificity of 99.94%, assuming the
six samples were in fact negative and falsely scored positive. This
specificity for the 1st-generation Amorfix test is equivalent to the
specificity achieved by the current 3rd-generation blood screening tests for
HIV antibodies currently in use worldwide in blood transfusion centres to
assure the safety of blood. The European Union's In Vitro Diagnostics
Technical Group has recommended testing a minimum of 5,000 samples to verify
specificity of at least 99.5% for a vCJD blood test.
"The EP-vCJD(TM) test fits well into the normal pathogen testing program
for blood donations. The test was quickly established in our facilities and
has demonstrated excellent performance," said Dr. Jean-Pierre Cazenave,
Director of the EFS-Alsace Blood Transfusion Center in Strasbourg.
The France feasibility study will now expand to test anonymous blood
donations from two other regional centres in France.
Amorfix Life Sciences Ltd. (TSX:AMF) is a theranostics company developing
therapeutic products and diagnostic devices targeting brain-wasting diseases
including ALS, Alzheimer's Disease, Parkinson's Disease and variant
Creutzfeldt-Jakob Disease (vCJD). Amorfix's proprietary Epitope Protection(TM)
(EP) technology enables it to specifically identify very low levels of
aggregated misfolded proteins (AMP) in a sample of normal protein. Aggregated
misfolded proteins are a common element of many brain wasting diseases and the
ability to identify AMPs and understand their structure and mechanism of
folding are the first steps to developing new treatments for these devastating
diseases. Amorfix's lead programs are a diagnostic blood screening test for
vCJD and a therapy for ALS.
This information release may contain certain forward-looking information.
Such information involves known and unknown risks, uncertainties and other
factors that may cause actual results, performance or achievements to be
materially different from those implied by statements herein, and therefore
these statements should not be read as guarantees of future performance or
results. All forward-looking statements are based on the Company's current
beliefs as well as assumptions made by and information currently available to
it as well as other factors. Readers are cautioned not to place undue reliance
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uncertainties identified by the Company in its public securities filings,
actual events may differ materially from current expectations. The Company
disclaims any intention or obligation to update or revise any forward-looking
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For further information:
For further information: Dr. George Adams, President & Chief Executive
Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6959, Fax: (416) 847-6899,
firstname.lastname@example.org; Dr. Neil Cashman, Chief Scientific Officer, Amorfix
Life Sciences Ltd., Tel: (778) 994-2626, Fax: (416) 847-6899,