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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.

  1. Accreditations

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.

CLIA

Centers for Medicare and Medicaid Services - Rostock Lab

CENTOGENE received the certificate of accreditation CLIA registered #99D2049715

  • CLIA certificate of accreditation #99D2049715

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Centers for Medicare and Medicaid Services - Boston Lab

CENTOGENE received the certificate of accreditation CLIA registered #22D2154474

  • CLIA certificate of accreditation #22D2154474

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CAP

College of American Pathologists CAP ISO15189

CENTOGENE is CAP accredited CAP ISO15189

  • College of American Pathologists CAP ISO15189

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College of American Pathologists – Rostock Lab

CENTOGENE is CAP accredited #8005167

College of American Pathologists – Biorepository Rostock Lab

CENTOGENE is CAP accredited #8574447

  • CAP Rostock Lab Biorepository accredited #8574447

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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

NPI #1386148971

Local US Accreditations

Pennsylvania Department of Health

CENTOGENE received the Clinical Laboratory Permit registered #34579

  • Clinical laboratory permit Pennsylvania

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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.

International Accreditations

Australian Government Department of Health

CENTOGENE received the Australian Register of Therapeutic Goods Certificate

  • Australian Register of Therapeutic Goods Certificate

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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

Internet Privacy Standards

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.

PCI DSS Compliance Certificate

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.