Simsen Diagnostics has an ISO 15189 application in progress for its ctDNA analysis in the EU under GDPR.

Simsen Diagnostics is the European specialist in tumour-informed ctDNA analysis for oncology research, clinical trials and precision cancer care. We sequence each patient's tumour, then track those mutations in plasma or cerebrospinal fluid for MRD, recurrence and treatment monitoring. You choose how it runs. LabSuite brings SiMSen-Seq, personalised panel design and error-corrected analysis in-house on the Illumina instruments you already own, with no proprietary hardware and raw data you fully control. Or send samples to our EU laboratory and we run it for you. Either way, analysis stays within the EU under GDPR. Our technology is built for the hard cases: low tumour burden, small samples, paediatric and CNS tumours, and early-phase trials that need a sensitive molecular endpoint.