CE IVD-Marking

IndiTreat® is the first CE-marked functional drug sensitivity test on patient-derived tumoroids, delivering the highest level of quality, safety and traceability. Over 450 million people in the European Economic Area (EEA) place their trust in the quality, reliability, and safety of in-vitro diagnostic devices bearing the CE mark. This trust stems from manufacturers’ commitment and engagement to willingly subject themselves to the standards and assessment procedures associated with CE-marking.

Responsible. Reliable. Ready-for-use

Manufacturers of in-vitro diagnostic devices recognize the huge responsibility that comes with developing and delivering products that directly impact the health and well-being of users and patients across the EEA. The journey towards obtaining the CE mark is not merely a regulatory requirement but a profound demonstration of dedication to excellence and commitment to delivering the highest standards of quality. We fully appreciate the responsibility we have here.

2cureX willingly embarked on delivering the necessary compliance, and we are fully versed in terms of the EU regulations and directives governing in-vitro diagnostic devices. The necessary engagement goes beyond a checklist of requirements and Research-Use-Only tests. It involves a comprehensive understanding of the expectations, guidelines, and best practices set forth by the regulatory authorities and lived by the clinical experts. It is they who ensure and provide the best possible diagnostics and subsequent healthcare for patients with colorectal cancer on a day-to-day basis. We provide a new and essential tool.

Leveraging our expertise, delivering new insights

2cureX invests significant resources, time, and expertise into every step of our product development process. We design and engineer our in-vitro diagnostic devices with precision, ensuring that each component and feature conforms seamlessly to the strict safety and quality standards. By embracing these standards, we demonstrate our commitment to protecting the health and well-being of the individuals who rely on our products and inform precision medicine-based therapeutical decisions.

Our engagement in submitting to these standards fosters a two-way relationship with healthcare providers and their patients. The CE mark has become a symbol of assurance that the in vitro diagnostic device they rely on has undergone thorough scrutiny and is designed to meet the highest standards of quality and safety. Prescribers and patients alike rely on our devices with confidence in the clinical setting, knowing that their health and well-being are safeguarded when entrusting us with an IndiTreat® test.

For more information about our clinical evidence and CE-marking, please go here.