CENTOGENE Accreditation Header

Accreditations

All over the world, patients value our expertise in human genetic testing. CENTOGENE holds numerous international quality accreditations, demonstrating our commitment to excellence across all our services.

Quality Driven to Achieve Scientific Excellence

CENTOGENE follows the strictest quality criteria in an effort 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 has been recognized by our CAP, CLIA and ISO 15189 certifications. CENTOGENE’s QMS integrates into every aspect of our operations, spanning from data integrity and privacy, patient safety, responsibility 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.
 

CLIA

Centogene CLIA Accreditation PDF

Centers for Medicare and Medicaid Services – Rostock Lab

CENTOGENE received the certificate of accreditation CLIA registered #99D2049715

CENTOGENE CLIA Certificate Cambridge

Centers for Medicare and Medicaid Services – Cambridge, Massachusetts Lab

CENTOGENE received the certificate of accreditation CLIA registered #22D2154474

CAP

CENTOGENE CAP Accreditation Certificate PDF

College of American Pathologists CAP ISO15189

CENTOGENE is CAP accredited CAP ISO15189

CENTOGENE Biorepository CAP Accreditation PDF

College of American Pathologists – Biorepository Rostock Lab

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

Data and Security

CENTOGENE Urkunde ISO27001 2020 PDF

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.

CENTOGENE IPS Urkunde PDF

Internet Privacy Standards – CentoPortal

CentoPortal is certified for providing safety and privacy according to the "internet privacy standards" by German accreditor datenschutz-cert.

CENTOGENE Compliance Certificate Logo

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

CENTOGENE Illumina Propel Certificate PDF

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.

US State Licenses

California State License

CENTOGENE is licensed to operate as a clinical laboratory by the California Department of Public Health

CMS Provider Identifier

Centers for Medicare and Medicaid Services (CMS)

CENTOGENE US LLC NPI (National Provider Identifier) number: 1386148971

NPI #1386148971