Glasgow, United Kingdom; 22nd October 2018: Sistemic Ltd. is pleased to announce the completion of a Global Service and License Agreement for its SistemPSCCheck™ assay with Australian stem cell and regenerative medicine company, Cynata Therapeutics Ltd. The agreement will see the use of the SistemPSCCheck™ assay for the assessment of residual pluripotent stem cells in Cynata’s current iPSC-derived MSC clinical candidate CYP-001, as well other planned iPSC-derived MSC products.
SistemPSCCheck™ is a first-in-class miRNA-based assay for high sensitivity assessment of residual pluripotent stem cells (PSCs) in derived cell preparations. It has been specifically designed to offer high levels of safety for characterisation and batch release testing to support the clinical and commercial development of PSC cell-derived cell therapy products.
Jim Reid, CEO stated, "We have been working with Cynata for a number of years now but this agreement is a significant milestone for Sistemic. Working with the company who is leading the field in iPSC-derived cell therapies is a fantastic position for Sistemic to be in. On the back of Cynata’s recently announced positive clinical data, this is another step on the way to the introduction of commercially viable, efficacious and safe cell therapy products”.
David Mallinson, VP of Scientific Operations added, "Over the past two years we have developed and validated the SistemPSCCheck™ assay to produce an off-the-shelf assay product for residual PSC assessment with class-defining detection sensitivity and diagnostic accuracy. We we are delighted to be working with Cynata using SistemPSCCheck™ and are looking forward to supporting the further clinical development of CYP-001, as well as their other planned iPSC-derived MSC products".
Sistemic’s primary business is focused on providing innovative micro-RNA-based problem-solving services and products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell and Gene Therapy research, development and manufacturing markets.
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