CENTOGENE (Nasdaq: CNTG), a commercial-stage company focused on
rare diseases that transforms real-world clinical and genetic data
into actionable information for patients, physicians, and
pharmaceutical companies, announced today that its validated
COVID-19 test kit, called CentoKit-19™, is now available in Germany
on Amazon.de. CENTOGENE is the first provider worldwide to make its
innovative and comprehensive testing solution for the detection of
SARS-CoV-2 virus RNA available to all individuals in Germany via
the online marketplace.
“Preventive, widespread testing represents a further, vital, and
complementary individual measure when it comes to detecting and
breaking infection chains at the earliest possible point. In
combination with the already established measures, an end-to-end
COVID-19 testing solution will support all of us as we return to
the new normal – allowing us to reopen schools, attend concerts, or
simply visit our families,” said Prof. Arndt Rolfs, founder and CEO
of CENTOGENE. “By delivering a comprehensive offering, including
detailed, easy-to-follow instructions, we are able to support our
local and global community with a high quality, affordable, and
accessible solution for everyone – delivered directly to their
doorstep.”
About CentoKit-19™
The CentoKit-19™ consists of a CE-labelled CentoSwab™
(two-component dry plastic swab for oropharyngeal swab sampling),
collection tube with barcode sticker, labelled and prepaid return
boxes, UN3373 plastic bag, and a package insert. More information
on the testing process, including the simplified and convenient
workflow, can be found at www.centogene.com/corona.
The CentoKit-19™ is available in Germany on both Amazon.de and
AmazonBusiness.de. For Amazon customers, a single test kit as
described above is available, and a family kit, which includes four
complete kits, can also be purchased. For Amazon Business
customers, as well as Amazon customers, test kits containing either
25 single kits or 50 units of the CentoSwab™ are available.
Dedicated to the Highest Quality Testing and Data
Security
CENTOGENE is dedicated to providing quality testing to the
global community. The test detects an infection of SARS-CoV-2 by
detecting specific RNA molecules that originate from the genome of
the disease-causing coronavirus. The diagnostic procedure includes:
RNA extraction, transcription of the RNA into complementary DNA
(cDNA) by means of reverse transcription, and amplification
(multiplication) of virus-specific cDNA by means of polymerase
chain reaction (PCR). The presence of cDNA in the amplification
product shows that virus particles were in the sample, and thus
indicates an active infection with SARS-CoV-2.
The method used is based on the published method by Prof.
Drosten (Charité, Berlin). This test is referred to in the WHO
documents as the “WHO Charité” test. The analytical steps and in
particular the target sequences used to detect the viral RNA by
RT-PCR correspond exactly to the publication by Corman, Bleicker,
Brünink, Drosten, Landt, Koopmans, Zambon from January 17, 2020,
and were validated in interlaboratory tests, as well as in
cooperation with the laboratory by Prof. Drosten. The test has also
been validated in CENTOGENE's CAP / CLIA / ISO certified analytical
laboratory and has received Emergency Use Authorization (EUA) by
the United States Food and Drug Administration (FDA) for use by
authorized laboratories.
In addition to the kit and the high-throughput diagnostic
procedure, the comprehensive test solution offers a secure
SARS-CoV-2 Test Registration Portal – maintaining stringent data
privacy measures, while delivering time-sensitive diagnostics.
CENTOGENE acts in compliance with the current specifications of
GDPR (German Data Protection Regulation
‘Datenschutzgrundverordnung’) and Health Insurance Portability and
Accountability Act (HIPAA).
About CENTOGENE
CENTOGENE engages in diagnosis and research around rare diseases
transforming real-world clinical and genetic data into actionable
information for patients, physicians, and pharmaceutical companies.
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, including epidemiological and
clinical data, as well as innovative biomarkers. CENTOGENE has
developed a global proprietary rare disease platform based on our
real-world data repository with approximately 3.0 billion weighted
data points from over 530,000 patients representing over 120
different countries as of March 31, 2020.
The Company’s platform includes epidemiologic, phenotypic, and
genetic data that reflects a global population, and also a biobank
of these patients’ blood samples. CENTOGENE believes this
represents the only platform that comprehensively analyzes
multi-level data to improve the understanding of rare hereditary
diseases, which can aid in the identification of patients and
improve our pharmaceutical partners’ ability to bring orphan drugs
to the market. As of March 31, 2020, the Company collaborated with
39 pharmaceutical partners covering over 45 different rare
diseases.
Important Notice and Disclaimer
This press release contains statements that constitute “forward
looking statements” as that term is defined in the United States
Private Securities Litigation Reform Act of 1995, including
statements that express the Company’s opinions, expectations,
beliefs, plans, objectives, assumptions or projections regarding
future events or future results, in contrast with statements that
reflect historical facts. Examples include discussion of our
strategies, financing plans, growth opportunities and market
growth. In some cases, you can identify such forward-looking
statements by terminology such as “anticipate,” “intend,”
“believe,” “estimate,” “plan,” “seek,” “project” or “expect,”
“may,” “will,” “would,” “could” or “should,” the negative of these
terms or similar expressions. Forward looking statements are based
on management’s current beliefs and assumptions and on information
currently available to the Company. However, these forward-looking
statements are not a guarantee of our performance, and you should
not place undue reliance on such statements. Forward-looking
statements are subject to many risks, uncertainties and other
variable circumstances, such as negative worldwide economic
conditions and ongoing instability and volatility in the worldwide
financial markets, the effects of the COVID-19 pandemic on our
business and results of operations, 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 or other
factors. Such risks and uncertainties may cause the statements to
be inaccurate and readers are cautioned not to place undue reliance
on such statements. Many of these risks are outside of the
Company’s control and could cause its actual results to differ
materially from those it thought would occur. The forward-looking
statements included in this press release are made only as of the
date hereof. The Company does not undertake, and specifically
declines, any obligation to update any such statements or to
publicly announce the results of any revisions to any such
statements to reflect future events or developments, except as
required by law.
For further information, please refer to the Risk Factors
section in our Annual Report for the year ended December 31, 2019
on Form 20-F filed with the SEC on April 23, 2020 and other current
reports and documents filed with the U.S. Securities and Exchange
Commission (SEC). You may get these documents by visiting EDGAR on
the SEC website at www.sec.gov.
Media Contact:
CENTOGENE
Ben Legg
Corporate Communications
press@centogene.com
MC Services AG
Anne Hennecke / Susanne Kutter
0211 529252 22 / 0211 529252 27
centogene@mc-services.eu
FTI Consulting
Bridie Lawlor
+1.917.929.5684
bridie.lawlor@fticonsulting.com
Centogene NV (NASDAQ:CNTG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Centogene NV (NASDAQ:CNTG)
Historical Stock Chart
From Apr 2023 to Apr 2024