Avacta Group’s shares are rising after the Pharmaceutical company announced its Avacta Life Sciences’ diagnostics division has achieved ISO 13485 certification.
The certification is for the quality management system for the manufacture and distribution of Affimer reagents used in lateral flow, ELISA and immunodiagnostic in-vitro diagnostic devices.
The ISO 13485 standard defines the requirements for quality management for a developer and manufacturer of diagnostic products and medical devices.
Avacta said the certification provides them with a practical foundation to address the regulatory requirements and ensure the safety and quality of its products.
The certification also means that the CE mark for the AffiDX coronavirus antigen lateral flow test can be transferred to Avacta from its partner, Mologic, and Avacta will be a legal manufacturer of all future in-vitro diagnostic products.
“ISO 13485 certification is recognised globally by our partners, customers and regulatory bodies alike as the medical device industry benchmark for quality,” said Dr Alastair Smith, CEO of Avacta Group.
“This certification marks a major milestone for Avacta and underpins the product development strategy for the future of our diagnostics division,” he added.
Avacta’s share price is trading at 141p, up 4%, adding to its gains of over 20% in 2021.
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