Amorfix Life Sciences, a company focused on treatments and diagnostics for misfolded protein diseases, today announced it has achieved 100% specificity (no reproducible false positive results) upon testing 19,000 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.
"Our France study has demonstrated the feasibility of implementing the Amorfix test and has provided confidence that very few blood donors would be falsely identified during routine blood testing as potentially having vCJD" said Dr. George Adams, Chief Executive Officer of Amorfix. "With a new probable case of vCJD just announced by the Italian Ministry of Health, and the second vCJD case in Italy, this disease continues to demonstrate a long latency period prior to symptoms developing. High-risk nations should be preparing to conduct prevalence studies to assess the safety of their blood supply."
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. A total of 39,000 blood donations have now been tested at two EFS blood transfusion centers in France with a specificity of 99.95%, exceeding the 99.85% specificity required by the UK Blood Transfusion Service.