Living Cell Technologies Ltd (ASX:LCT) today announced it has been awarded the world's first xenotransplantation lab accreditation from the International Accreditation New Zealand (IANZ) body, in a major step towards commencing clinical trials of DiabeCell in New Zealand this year.
LCT is the first Company world-wide to receive IANZ accreditation for a xenotransplantation laboratory and this accreditation will ensure that LCT's laboratory test reports are accepted in forty-nine countries, including the US, Canada, United Kingdom, Australia and New Zealand.
This formal certification milestone along with recent regulatory approval for its clinical trial program, moves LCT towards starting a NZ human clinical trial later this calendar year with regional ethics approval the final requirement.
LCT's accredited laboratory will use specific diagnostic and monitoring tests to eliminate the risk of animal viruses passing to humans when transplanting animal cell products such as DiabeCell into human patients. The accredited laboratory will have the capability of testing for potential infections in recipients and to test for a range of appropriate viruses. This is a unique capability that has been developed by the Company over many years and is fully owned by LCT.
Although there has not been a single case of pig to human viral infection after hundreds of treatments and decades of use, the IANZ accreditation is a requirement before regulatory approval is provided for human clinical trial.
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Contact: Paris Brooke