CENTOGENE’s CentoCloud® Is Now CE-Marked as One of the Only Decentralized SaaS Platforms Compliant With European IVD Regulatory Framework
May 25 2022 - 6:30AM
Centogene N.V. (Nasdaq: CNTG), the commercial-stage essential
biodata life science partner for rare and neurodegenerative
diseases, today announced 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 deliver the best
diagnostic insights to local patients. As a cloud-based SaaS
platform, CentoCloud is specifically designed to support
laboratories with the execution of superior Next Generation
Sequencing (NGS)-based diagnostics. The Company’s fully automated
bioinformatics pipeline analyzes NGS data based on CENTOGENE’s
validated testing products, annotated with data from the CENTOGENE
Biodatabank.
CE-marking is required for all in vitro diagnostic (IVD) devices
sold in the European Economic Area (EEA) countries, as well as
Iceland, Norway, and Liechtenstein, and indicates that the device
may be legally commercialized in this area. Europe's new In Vitro
Diagnostic Regulation (IVDR 2017/746) will take full effect 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 diagnostics that is available via the cloud.
“At CENTOGENE, we are committed to enabling access to genetic
testing for patients around world,” said Kim Stratton, CEO of
CENTOGENE. “With the new IVD regulation going into place later this
week, CentoCloud will be one of Europe’s only commercialized
software on the market – underlining our commitment to being at the
forefront of offering safe and accessible patient solutions.”
To learn more about how CentoCloud facilitates the same high
quality and diagnostic accuracy as CENTOGENE offers in its own
certified state-of-the-art labs, visit:
https://www.centogene.com/diagnostics/centocloud
About CENTOGENE
CENTOGENE engages in diagnosis and research around rare diseases
transforming real-world clinical, genetic, and multiomic data to
diagnose, understand, and treat rare diseases. Our goal is to bring
rationality to treatment decisions and to accelerate the
development of new orphan drugs by using our extensive rare disease
knowledge and data. CENTOGENE has developed a global proprietary
rare disease platform based on our real-world data repository of
over 650,000 individuals representing over 120 different
countries.
The Company’s platform includes epidemiologic, phenotypic, and
genetic data that reflects a global population, as well as a
biobank of patients’ blood samples and cell cultures. CENTOGENE
believes this represents the only platform focused on comprehensive
analysis of multi-level data to improve the understanding of rare
hereditary diseases. It allows for better identification and
stratification of patients and their underlying diseases to enable
and accelerate discovery, development, and access to orphan drugs.
As of December 31, 2021, the Company collaborated with over 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 U.S. federal securities laws. Statements
contained herein that are not clearly historical in nature are
forward-looking, and the words “anticipate,” “believe,”
“continues,” “expect,” “estimate,” “intend,” “project,” and similar
expressions and future or conditional verbs such as “will,”
“would,” “should,” “could,” “might,” “can,” and “may,” are
generally intended to identify forward-looking statements. Such
forward-looking statements involve known and unknown risks,
uncertainties, and other important factors that may cause
CENTOGENE’s actual results, performance, or achievements to be
materially different from any future results, performance, or
achievements expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others,
negative economic and geopolitical conditions and instability and
volatility in the worldwide financial markets, possible changes in
current and proposed legislation, regulations and governmental
policies, pressures from increasing competition and consolidation
in our industry, the expense and uncertainty of regulatory
approval, including from the U.S. Food and Drug Administration, our
reliance on third parties and collaboration partners, including our
ability to manage growth and enter into new client relationships,
our dependency on the rare disease industry, our ability to manage
international expansion, our reliance on key personnel, our
reliance on intellectual property protection, fluctuations of our
operating results due to the effect of exchange rates, our ability
to streamline cash usage, our requirement for additional financing,
or other factors. For further information on the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to CENTOGENE’s business in general, see CENTOGENE’s risk
factors set forth 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. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and CENTOGENE’s specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events, or otherwise.
Media Contact:
CENTOGENE Ben Legg Corporate Communications
Press@centogene.com
Lennart Streibel Investor Relations
Investor.Relations@centogene.com
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