Elypta - Multi Cancer Early Detection Company Developing First GAGome -Based Tests - Receives ISO 13485:2016 Quality Certification
Stockholm, July 6, 2023: Swedish early cancer detection company Elypta is pleased to announce that the company has received certification of its quality management system to the ISO 13485:2016 standard for medical devices, in adherence to current regulatory requirements specific to the medical device industry. Elypta is advancing a broad study program based on measuring glycosaminoglycans (GAGomes) across different cancers with the first indication expected to be early detection of recurrence in renal cell carcinoma.“This certification is a fundamental step in our pursuit of the use of