Renishaw Diagnostics Ltd, provider of trace level detection technologies based on the exploitation of surface enhanced Raman scattering (SERS) and surface enhanced resonance Raman scattering (SERRS) for infectious disease research and molecular diagnostics applications, has announced that it has established a contract reagent manufacturing agreement with Gen-Probe’s Cardiff facility.
David Burns, CEO of Renishaw Diagnostics Ltd said, “We are very pleased to have engaged Gen-Probe to manufacture our RenDx molecular diagnostics kits for us under international standards. Gen-Probe has a very successful track record in manufacturing and selling their own nucleic acid based diagnostics kits to high quality manufacturing standards and we selected them as our manufacturing partner of choice for our RenDx reagent kits because of this experience.”
Burns continued, “We are moving our RenDx products into clinical evaluation studies in Europe and the USA for our three multiplex infectious disease panels and it was important to secure manufacturing of these to the standards that will allow us to go for regulatory compliance approvals to market our products in Europe and the USA as certified in-vitro diagnostics products.”
Gen-Probe conforms to Good Manufacturing Practices and has management systems which are certified to ISO 13485:2003 and ISO 9001:2008.
Dr. Molly Price-Jones, Senior Director of the Gen-Probe Cardiff site, said, “We are delighted to be providing contract services for Renishaw Diagnostics Ltd to manufacture their in vitro diagnostic kits in our GMP manufacturing facilities in the UK.”
Gen-Probe is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests that are used primarily to diagnose human diseases and screen donated human blood.
The reagents for Renishaw Diagnostics will be manufactured in the company’s state of the art facilities in the UK, which provide controlled environments for the manufacture of CE marked in vitro diagnostic kits.