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 abroad 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 GAGomes to guide critical medical decisions in cancer. It is an enabler for potential future clinical use of the tests we are developing,” says Karl Bergman, CEO at Elypta.
“We are proud of receiving this certification and being able to send a clear message that quality matters in everything we do at Elypta. Quality management involves everyone at the company and this certification is a collective achievement by the entire team,” says Dilruba Ahmed, Director of Quality & Regulatory Affairs at Elypta.
The scope of the certification includes the design and development of in vitro diagnostic test kits and software for the detection of glycosaminoglycans in bioliquids used in the identification of renal cell carcinoma and multi-cancer early detection.
Elypta is a Swedish cancer detection company focused on reducing cancer mortality by enabling earlier detection and improved monitoring. The metabolism-based liquid biopsy platform in development measures a novel panel of biomarkers and utilizes machine learning algorithms to generate cancer-type specific GAG scores. Elypta is advancing a broad study program across different cancers with the first indication expected to be early detection of recurrence in renal cell carcinoma. www.elypta.com