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.
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