TORONTO, December 19 /PRNewswire/ --
- Available For Large-scale Testing of Populations to Identify Infected Carriers
Amorfix Life Sciences, a company focused on treatments and diagnostics for brain wasting diseases, today announced it achieved 100% sensitivity and 100% specificity in a second blinded trial of human blood samples using its EP-vCJD(TM) blood test in collaboration with the National Institute for Biological Standards and Control (NIBSC) in the United Kingdom.
We have now successfully completed both fresh and frozen human plasma testing, as part of a test validation process facilitated by NIBSC, said Dr. George Adams, Chief Executive Officer of Amorfix. The company has 50,000 test kits available to begin large-scale testing to determine the fraction of the population infected with vCJD. This information is vital for determining the need for routine testing of blood donations.
The UK Spongiform Encephalopathy Advisory Committee (SEAC) yesterday announced the first clinical case of vCJD in a patient with an MV genotype (all previous vCJD clinical cases were MM genotype) and suggested that 50 to 250 further cases might arise in the UK. This is consistent with a recent editorial in a leading medical journal, Lancet Neurology, published last week suggesting waves of vCJD cases could be expected.
This first MV case of vCJD now shows people with MV genotypes are not resistant to vCJD, but may incubate the disease for a longer time before developing neurological symptoms. Yesterday's report of vCJD with MV genetics shows we are not out of the woods with this tragic epidemic, and also raises the possibility of ongoing blood-borne transmission of vCJD from silent carriers of the infection, said Dr. Neil Cashman, Chief Science Officer of Amorfix.
In the most recent panel, NIBSC provided Amorfix with 500 frozen blinded human plasma samples which included some samples spiked with vCJD brain prions. The EP-vCJD(TM) test successfully detected all (100% sensitivity) of the spiked samples down to a 1 in 100,000 dilution of 10% brain homogenate (1/1,000,000 dilution of vCJD brain). The test scored one sample initially positive (initial reactivity of 99.8%) but upon repeat testing correctly identified the sample as negative (specificity of 100%). In the first blinded panel, Amorfix tested 1,000 fresh UK plasma samples with identical perfect results.
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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