TORONTO, Sept. 9 /CNW/ - Amorfix Life Sciences, a company focused on treatments and diagnostics for brain wasting diseases, today announced an update on the regulatory process in the European Union (EU) and manufacturing for vCJD blood screening tests.
The EU Commission's In Vitro Diagnostics Technical Group and government representatives from EU member countries met in Brussels earlier this summer to consider expert scientific information in determining the process for regulating vCJD tests. Amorfix attended as an industry expert and presented the European Diagnostic Manufacturer's Association's (EDMA) position on the standards that should be established for a first blood screening test for vCJD. The EDMA proposal was broadly circulated for comments to be reviewed at the next Commission meeting planned for early October.
"Amorfix and EDMA are taking a leadership role in advising on the scientific and practical considerations involved in regulating vCJD diagnostic blood screening assays," said Dr. George Adams, President & CEO, Amorfix. "We are encouraged by the broad EU member state support for the establishment of regulations for this test."
Amorfix has now established ISO 13485:2003 certification at its facility in Mississauga, Ontario and in its new Prion Containment Laboratory which has also been certified by the Canadian Food Inspection Agency and the Public Health Agency of Canada. This laboratory is required for the development of prion-related assays and for the quality control and release of test kits. Real-time testing of the EP-vCJD(TM) Blood Screening Assay diagnostic kit has now confirmed a shelf life of 12 months for all critical reagents.
"Amorfix's ISO quality systems have been established for manufacturing and distribution of the vCJD blood screening test," said Milan Striez, Director of Operations at Amorfix. "The on-going shelf-life testing continues to demonstrate stability of the test kits and we are confident that the stability will meet the standards of our prospective customers."
Amorfix Life Sciences Ltd. (TSX:AMF - News) 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.
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For further information
Dr. George Adams, President & Chief Executive Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6959, Fax: (416) 847-6899, email@example.com
James Parsons, Chief Financial Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899, firstname.lastname@example.org
Source: Amorfix Life Sciences Ltd.