"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.

amorfix

He explained that currently only about 15%-20% of donor lungs are acceptable for transplantation since lungs are susceptible to injuries during the brain-death process or from intensive care unit-related lung complications. These numbers can easily be doubled with this technique to treat and improve donor lungs.

Dr. Marcelo Cypel, a transplant surgical fellow at TGH, echoed Dr. Keshavjee's sentiments. "This new technique heralds the beginning of a new era in transplantation since it has allowed us to progress from preserving donor lungs to actually being able to repair some of the injury before transplantation. And we have done this using a unique strategy on donor lungs outside the body."

After the donor lungs are removed from a deceased donor and taken to the hospital, they are carefully transferred to a protective, transparent bubble-like chamber that the Toronto team developed in collaboration with Vitrolife, a company specializing in developing lung preservation solutions To avoid injuring the lungs, a series of precise steps are followed when connecting them to a circuit composed of a pump, ventilator and filters through which flow oxygen, nutrients and a special solution. The temperature is incrementally increased until it reaches 37 degrees Celsius over about 30 minutes, and ventilation of the lungs is begun during that time. Lung function is evaluated regularly on key indicators, such as how easily the lungs can exchange oxygen, airway pressure and lung compliance. Previously published research by Drs. Keshavjee and Cypel on this system (December 2008 issue of the Journal of Heart and Lung Transplantation ) has shown that lungs can be safely kept on this circuit for 12 hours in order to assess, maintain and treat them before successfully transplanting them.

Currently, about 80 patients are waiting for either a lung or heart-lung transplant in Ontario. About 20% of those on the wait list will die before they receive a lung transplant. In Canada, the number of people waiting for a lung transplant has doubled in the past 10 years, with 252 Canadians waiting to receive a lung transplant in 2006, compared to 119 in 1997. Two hundred and ninety-nine (299) Canadians died while waiting for a lung transplant between 1997 and 2006.

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