- 30,000 Donations Tested to Date -
TORONTO, Sept. 21 /CNW/ - Amorfix Life Sciences, a company focused on treatments and diagnostics for brain wasting diseases, today announced it has achieved 100% specificity (no reproducible false positive results) upon testing 10,000 blood donations for variant Creutzfeldt-Jakob Disease ("vCJD"). with the EP-vCJD(TM) Blood Screening Assay at l'Etablissement Français du Sang de Pyrénées Méditerrannée ("EFS-PM") in Montpellier, France.
"France continues to take a leading role in assessing the feasibility of testing routine blood donations for vCJD. The study in Montpellier included testing of fresh blood within 24 hours of collection and processing of the plasma with an automated sample handling system. This is the exact process that would be used in routine blood testing" said Dr. George Adams, Chief Executive Officer of Amorfix. "These results should give governments confidence that very few blood donors will be falsely identified as potentially having vCJD during routine blood screening."
The blood samples were collected and tested as part of a large-scale study being conducted to demonstrate the feasibility of routine testing of blood donations for vCJD. Using the settings for maximum sensitivity of 1:1,000,000 dilution of vCJD brain, as verified by testing at the NIBSC in the UK, the test in EFS-PM was 100% specific. The test continues to demonstrate its readiness for use by high-risk nations to conduct prevalence studies to assess the safety of their blood supply.
Including these 10,000 blood samples collected and tested at EFS-PM, a total of 30,000 blood donations have now been tested at two sites in France. 99.90% specificity was previously reported for 20,000 samples tested at EFS-Alsace in Strasbourg. In both blood transfusion centers using two lots of kits, the EP-vCJD(TM) test performed better than the 99.85% specificity required by the UK Blood Transfusion Service.
vCJD is rare and fatal human form of a family of diseases known as transmissible spongiform encephalopathy ("TSE") diseases caused by prions. Other TSEs are bovine spongiform encephalopathy ("BSE") in cattle, scrapie in sheep and goats, and chronic wasting disease in deer, elk and moose. Since 1996, a few hundred people living in or visiting Great Britain and other European countries have been diagnosed with vCJD due to the consumption of BSE-infected meat. People can incubate prion disease for 30 to 50 years and could be capable of transmitting it to others throughout that time. Indeed, it is estimated that more than 20,000 people are currently incubating the disease. Recently, five people have been infected through blood transfusions and thousands of people have received blood fractions made from vCJD-infected plasma. There is a general concern that vCJD is now within the blood transfusion systems and, as a result, a screening assay for blood is urgently required.
About the EP-vCJD(TM) Blood Screening Assay
Approximately 81 million units of blood are collected annually and tested for infectious agents, such as HIV-1 and hepatitis viruses at a cost of more than US$4 billion. Until now, however, there has been no way of protecting the blood supply by testing for vCJD. Amorfix is changing that through the Company's development of EP-vCJD(TM) - a test for the presence of vCJD prions in human blood that allows for the selective detections of prions and not the precursor normal protein.
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 press 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.
SOURCE Amorfix Life Sciences Ltd.
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, email@example.com