Regulation & Quality

EarlyCDT—Lung tests are performed in professional laboratories around the world using our test kit. This kit is CE marked and meets the strict EU standards of manufacturing and quality control of the In Vitro Diagnostics Medical Devices Directive 98/79/EC.

Oncimmune’s Quality Management System is certified to EN ISO 13485:2016 for the design, development and manufacture of in vitro diagnostic immune biomarker devices for early detection of solid tumour cancers (ISO Certificate).

Oncimmune is fully compliant with HIPAA and EU data protection regulations.

Oncimmune complies with all other relevant US and EU regulations.

Oncimmune is in compliance with Korean Good Manufacturing Practice. Oncimmune has passed an audit performed by South Korean Ministry of Food and Drug Safety in November 2017 (KGMP certificate)