Accreditations
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.
Quality Driven to Achieve Scientific Excellence
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.
CENTOGENE Holds the Following Accreditations and Certifications
We continually participate in the international external proficiency testing schemes of the European Molecular Genetics Quality Network (EMQN) and the College of American Pathologists (CAP) to ensure technical and medical competency and proficiency.
CAP
College of American Pathologists CAP ISO15189
CENTOGENE is CAP accredited CAP ISO15189
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 2021 program year
CLIA
Centers for Medicare and Medicaid Services – Rostock Lab
CENTOGENE received the certificate of accreditation CLIA registered #99D2049715
Centers for Medicare and Medicaid Services – Cambridge, Massachusetts Lab
CENTOGENE received the certificate of accreditation CLIA registered #22D2154474
CMS Provider Identifier
Centers for Medicare and Medicaid Services (CMS)
CENTOGENE US LLC NPI (National Provider Identifier) number: 1386148971
NPI #1386148971
Data and Security
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.
Internet Privacy Standards – CentoPortal
CentoPortal is certified for providing safety and privacy according to the "internet privacy standards" by German accreditor datenschutz-cert.
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.
Industry
Illumina Propel Certification for Core and Service Labs
CENTOGENE has successfully completed certification for HiSeq 4000 System, NextSeq System and MiSeq System provided by Illumina Inc.
Medical Devices
Certification according to DIN EN ISO 13485 – for CENTOGENE’s in vitro diagnostic medical device
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.
US State Licenses
California State License
CENTOGENE is licensed to operate as a clinical laboratory by the California Department of Public Health
Pennsylvania Clinical Laboratory Permit
CENTOGENE US, LLC is permitted to operate as a Clinical Laboratory by the Pennsylvania Department of Health
Massachusetts State License
CENTOGENE is licensed to operate as a clinical laboratory by the Massachusetts Department of Public Health