TORONTO, Canada, January 13 /PRNewswire/ --
- Amorfix Demonstrates vCJD Test can be Used Routinely to Test Blood Donations
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.
About Amorfix
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 on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and 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 statements, whether as a result of new information, future events or otherwise.
For further information: Dr. George Adams President Chief Executive Officer Amorfix Life Sciences Ltd. Tel: +1-416-847-6959 Fax: +1-416-847-6899 george.adams@amorfix.com Dr. Neil Cashman Chief Scientific Officer Amorfix Life Sciences Ltd. Tel: +1-778-994-2626 Fax: +1-416-847-6899 neil.cashman@amorfix.com
For further information: Dr. George Adams, President Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: +1-416-847-6959, Fax: +1-416-847-6899, george.adams@amorfix.com; Dr. Neil Cashman, Chief Scientific Officer, Amorfix Life Sciences Ltd., Tel: +1-778-994-2626, Fax: +1-416-847-6899, neil.cashman@amorfix.com
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