Sweden based early cancer detection company announced it has received the ISO 13485:2016 quality certification for its quality management system.
The company is advancing a study program, which is based on measurements of GAGomes, or glycosaminoglycans, which are biomolecules found in bioliquids that can serve as valuable indicators of various types of cancers.
By measuring and analysing GAGomes, Elypta aims to provide early and accurate detection of cancer which has the potential to improve patient outcomes and reduced mortality rates.
Following the announcement Elypta CEO Karl Bergman said: “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.”
The certification covers 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.
“Quality management involves everyone at the company and this certification is a collective achievement by the entire team,” said Dilruba Ahmed, Director of Quality & Regulatory Affairs at Elypta.
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The potential for using GAGomes as biomarkers for multicancer early detection was evidenced in Elypta’s research for its Miram kit.
In March 2023 the company scooped up a $1m prize fund from the Roddenberry Foundation for its early cancer detection test. In 2022 the firm managed to secure $21m in a Series A financing round for the development of a metabolism-based multi-cancer early detection (MCED) test.