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 and have been found compliant in this regard in several audits by our customers.
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.
Centers for Medicare and Medicaid Services
CENTOGENE received the certificate of accreditation CLIA registered #99D2049715
The Commonwealth of Massachusetts
CENTOGENE received the certificate of accreditation CLIA registered #22D2154474 License number 5456
College of American Pathologists CAP ISO15189
CENTOGENE is CAP accredited CAP ISO15189
College of American Pathologists – Rostock Lab
CENTOGENE is CAP accredited #8005167
College of American Pathologists – Boston Lab
CENTOGENE is CAP accredited #8417628
CMS Provider Identifier
Centers for Medicare and Medicaid Services (CMS)
CENTOGENE US LLC NPI (National Provider Identifier) number: 1386148971
Local US Accreditations
Pennsylvania Department of Health
CENTOGENE received the Clinical Laboratory Permit registered #34579
State of Florida CLINICAL LABORATORY
CENTOGENE AG has completed the application and approval of the Florida State license for Clinical Laboratory Services- High Complexity Testing.
Maryland Department of Health and Mental Hygiene
CENTOGENE received the medical laboratory permit for the performance of medical laboratory tests in molecular genetics.
Australian Government Department of Health
CENTOGENE received the Australian Register of Therapeutic Goods Certificate
Ministry of Food and Drug Safety South Korea
CENTOGENE has received the Certificate of GMP from the Ministry of Drug and Safety in South Korea
Data and Security
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.
PCI DSS Compliance Certificate
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.