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) 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
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; James Parsons, Chief Financial Officer, Amorfix Life
Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899,