CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. Our ISO, CAP, and CLIA certified multiomic reference laboratories in Germany enable us to deliver precision medicine powered by Phenomic, Genomic, Transcriptomic, Epigenomic, Proteomic, and Metabolomic datasets.
CENTOGENE follows the strictest quality criteria to meet our customer’s requirements in clinical diagnostics, clinical trial services, and research and development.
This is supported by CENTOGENE’s multi-discipline quality management system (QMS), which is recognized by our ISO, CAP, and CLIA certifications. CENTOGENE’s QMS is integrated into every aspect of our operations, spanning from data integrity and privacy to scientific research and innovations.
Furthermore, as a full-service company, we follow applicable and market-standard good laboratory practice (GLP) and good manufacturing practice (GMP) guidelines.
College of American Pathologists Laboratory Accreditation
CENTOGENE is CAP accredited: Laboratory Accreditation Program
College of American Pathologists Proficiency Testing Participation
CENTOGENE has successfully participated in the CAP Proficiency Testing for the 2022 program year
Centers for Medicare and Medicaid Services (CMS)
CENTOGENE US LLC NPI (National Provider Identifier) number: 1386148971
Information Security Management System – ISO/IEC 27001:2017 Certificate
CENTOGENE's processes and IT systems are ISO/IEC 27001:2017 certified by the independent accreditor datenschutz cert GmbH, ensuring a high level of confidentiality, availability, and integrity to all processed data.
PCI DSS Compliance Certification
CENTOGENE is certified as Payment Card Industry Data Security Standard (PCI DSS) compliant for protecting customers' payment card data in accordance with current requirements.
Certification for In Vitro Diagnostic Medical Devices – EN ISO 13485
CENTOGENE’s quality management system meets all applicable requirements of DIN EN ISO 13485:2021 and Regulation (EU) 2017/746 of the European Parliament and of the council on in vitro diagnostic medical devices.