Amorfix Life Sciences has announced it achieved 100% sensitivity and 100% specificity in a second blinded trial of human blood samples using its EP-vCJD 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.