vCJD blood test achieves 100% accuracy
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg. “This approval offers health care professionals an additional choice for treating moderate to
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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.
Scientists investigating the 2006 Northwick Park drug-trial disaster that left six healthy volunteers hospitalised say they have developed new pre-clinical tests that could have stopped the trial from ever going ahead. But Dr Stephen Poole, speaking at the British Pharmacological Society’s Winter Meeting in Brighton, said that research is still “ongoing” to understand why the
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Power3 Medical Products, Inc. said today that two CIP patent applications have been filed for BC-SeraPro Breast Cancer blood test and biomarkers by Dr. Ira Goldknopf, its president and Chief Scientific Officer. The applications for utility patents are entitled “Identities, Specificities, and Use of Twenty Two (22) Differentially Expressed Protein Biomarkers for Blood Based Diagnosis
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Avoiding detection just got harder for drug cheats who try to use a particular range of untested, but potentially enhancing, compounds. In the past, tests have been developed once a drug is known to be in circulation. Now a German research team has developed tests for a class of drugs that they believe could be
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The use of human papillomavirus (HPV) DNA testing as an initial screening step followed by triage with a standard Pap test (cytology) and repeat HPV DNA testing may increase the accuracy of cervical cancer screening, according to a study in the Jan. 13 online issue of the Journal of the National Cancer Institute. Compared to
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A new “barcode chip” developed by researchers at the California Institute of Technology (Caltech) promises to revolutionize diagnostic medical testing. In less than 10 minutes, and using just a pinprick’s worth of blood, the chip can measure the concentrations of dozens of proteins, including those that herald the presence of diseases like cancer and heart
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