CentoCloud® by CENTOGENE is now CE marked as one of the only decentralized SaaS platforms compliant with the European IVDCE regulatory framework

  • CentoCloud, CENTOGENE’s cloud-based software-as-a-service (SaaS) platform, is CE marked under the In Vitro Diagnostics Directive (98/79/EC)
  • The CE mark is required for all in vitro diagnostic (IVD) devices to be placed in European Economic Area (EEA) countries, as well as Iceland, Norway and Liechtenstein, and indicates that the device can be legally traded in this area
  • CentoCloud is one of the world’s only CE-marked IVD software for genomic diagnosis; Given the changing European regulatory landscape with the new In Vitro Diagnostics Regulation (IVDR 2017/746) taking full effect on May 26, 2022, this underlines CENTOGENE’s commitment to upholding the highest standards of the industry

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, May 25, 2022 (GLOBE NEWSWIRE) –Centogene NV (Nasdaq: CNTG), the essential commercial-stage life sciences biodata partner for rare and neurodegenerative diseases, announced today that its cloud-based software-as-a-service (SaaS) platform for the identification, prioritization and classification of human genetic variants is now CE marked under the In Vitro Diagnostics Directive (98/79/EC) .

CentoCloud enables laboratories around the world to establish and run state-of-the-art genomic testing and provide the best diagnostic information to local patients. As a cloud-based SaaS platform, CentoCloud is purpose-built to help labs run superior diagnostics based on Next Generation Sequencing (NGS). The Company’s fully automated bioinformatics pipeline analyzes NGS data based on validated CENTOGENE test products, annotated with data from the CENTOGENE Biodatabank.

The CE mark is required for all in vitro diagnostic (IVD) devices sold in European Economic Area (EEA) countries, as well as Iceland, Norway and Liechtenstein, and indicates that the device can be legally marketed in this area. The new European regulation on in vitro diagnostics (IVDR 2017/746) will come into full force on May 26, 2022.

As a CE marked IVD, CentoCloud can be applied to the clinical diagnosis of patients with genetic diseases. The clinical decision support platform is one of the world’s only CE-marked IVD software for genomic diagnosis that is available through the cloud.

“At CENTOGENE, we are committed to enabling access to genetic testing for patients around the world,” said Kim Stratton, CEO of CENTOGENE. “With the new IVD regulations coming into force later this week, CentoCloud will be one of the only software products in Europe on the market, underlining our commitment to be at the forefront of offering secure and accessible solutions. to patients.”

To learn more about how CentoCloud facilitates the same high diagnostic quality and accuracy that CENTOGENE offers in its own state-of-the-art certified laboratories, visit: https://www.centogene.com/diagnostics/centocloud

About CENTOGENE

CENTOGENE is committed to the diagnosis and research around rare diseases by transforming real-world clinical, genetic and multiomics data to diagnose, understand and treat rare diseases. Our goal is to bring rationality to treatment decisions and accelerate the development of new orphan drugs by using our deep knowledge and data on rare diseases. CENTOGENE has developed an exclusive global rare disease platform based on our real-world data repository of over 650,000 people representing over 120 different countries.

The Company’s platform includes epidemiological, phenotypic and genetic data that reflects a global population, as well as a biobank of patient blood samples and cell cultures. CENTOGENE believes it is the only platform focused on comprehensive multi-level data analysis to improve understanding of rare inherited diseases. It enables better identification and stratification of patients and their underlying diseases to enable and accelerate the discovery, development and access to orphan drugs. As of December 31, 2021, the Company collaborated with more than 30 pharmaceutical partners.

For more information, visit www.centogene.com and follow us on LinkedIn.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the United States federal securities laws. Statements contained herein that are not clearly historical in nature are forward-looking, and the words “anticipate”, “believe”, “continue”, “expect”, “estimate”, “intend to “, “to project”, and similar expressions and future or conditional verbs such as “will”, “would”, “should”, “might”, “could”, “may” and “may” are generally intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause the actual results, performance or achievements of CENTOGENE to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. . These risks and uncertainties include, among others, adverse economic and geopolitical conditions as well as instability and volatility in global financial markets, possible changes in current and proposed laws, regulations and government policies, pressures from increasing competition and consolidation in our industry, expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our dependence on third parties and partners collaboration, including our ability to manage growth and build new customer relationships, our reliance on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations in our results of operations due to the effect of changes, our ability to rationalize the use of cash, our need for additional financing or other factors. For more information about the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with CENTOGENE’s business generally, see CENTOGENE’s risk factors stated in CENTOGENE’s Form 20-F filed on March 30, 2022, with the Securities and Exchange Commission (the “SEC”) and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date hereof, and CENTOGENE specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact:

CENTOGEN
Ben Legg
Business communication
[email protected]

Lennart Streibel
Investor Relations
[email protected]


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