CAMBRIDGE, Massachusetts and ROSTOCK, Germany and BERLIN, July 23, 2020 (GLOBE NEWSWIRE) – CENTOGENE (Nasdaq: CNTG), a commercially run infrequent disease company that transforms real global clinical and genetic knowledge into actionable data for patients, doctors and pharmacists Corporations today announced that their validated COVID-19 verification kit, called CentoKit-19 ™, is now in Germany in Amazon.de. CENTOGENE is the first supplier in the world to implement its comprehensive and cutting-edge verification solution for SARS-CoV-2 RNA detection available to all Americans in Germany through the online marketplace.
“Preventive and generalized verification is an additional, important and complementary individual measure when it comes to detecting and breaking infectious chains as soon as possible. Combined with the measures already established, a comprehensive COVID-19 verification solution will serve us all as we return to the new general, allowing us to reopen schools, attend concerts or simply make a stop at our families,” said Professor Arndt Rolfs, founder and CEO of CENTOGENE. “By providing a comprehensive offer, adding detailed and easy-to-follow instructions, we can access our local and global network with a high-quality, affordable and available solution for everyone delivered directly to your door.”
About CentoKit-19 ™
The CentoKit-19 ™ consists of a CE-marked CEntoSwab ™ (two-component dry plastic swab for sampling in a 3opharyingeal swab), a barcode label sampling tube, classified return boxes and prepagas, a UN3373 plastic bag and a packing register. You’ll find more data about the testing process, adding the simplified and convenient workflow, at www.centogene.com/corona.
Dedicated to the quality and safety tests of knowledge.
CENTOGENE is committed to providing quality controls to the global community. Verification detects SARS-CoV-2 infection by detecting express RNA molecules that originate in the disease-coronavirus genome. The diagnostic procedure includes: RNA extraction, transcription of RNA in transcription of complementary DNA (CDNA) and amplification (multiplication) of the DNA chain reaction of cDNA (PCR). The presence of cDNA in the amplification product shows that there were viral remains in the sample, indicating an active SARS-CoV-2 infection.
The approach used is based on the approach published by Professor Drosten (Charity, Berlin). WHO documents refer to this verification as the “WHO Charitable Organization” verification. The analytical steps and, in particular, the objective sequences used to trip into viral RNA through RT-PCR correspond precisely to the publication through Corman, Bleicker, Brunnink, Drosten, Landt, Koopmans, Zambon of 17 January 2020, and have been validated in interlaboratory controls. , as well as in cooperation with the laboratory through Prof. Drosten. The verification was also validated in CENTOGENE’s CAP/CLIA/ISO qualified verification lab and obtained an Emergency Use Authorization (U.S.) from the U.S. Food and Drug Administration (FDA) for use through authorized laboratories.
In addition to the high-speed diagnostic kit and procedure, the comprehensive verification solution provides a secure SARS-CoV-2 verification registration portal, maintaining strict knowledge privacy measures, while providing urgent diagnostics. CENTOGENE operates in accordance with existing GDPR specifications (German Knowledge Coverage Regulation “Datenschutzgrundverordnung”) and the Health Insurance Portability and Accountability Act (HIPAA).
CENTOGENE engages in infrequent disease diagnoses and studies through the transformation of real-world clinical and genetic knowledge into actionable data for patients, physicians and pharmaceutical companies. Our purpose is to speed up remedy decisions and increase the progression of new orphan drugs using our deep wisdom of rare diseases, adding epidemiological and clinical knowledge as well as cutting-edge biomarkers. CENTOGENE has developed an exclusive global platform on rare diseases based on our repository of real-world knowledge with approximately 3.0 billion weighted knowledge problems from more than 530,000 patients representing more than 120 countries as of March 31, 2020.
The company’s platform includes epidemiological, phenotypic and genetic knowledge that reflects a global population, as well as a biobank of blood samples from these patients. CENTOGENE believes this is the only platform that comprehensively analyzes knowledge to multiple degrees to understand rare inherited diseases, which can help identify patients and the ability of our pharmaceutical partners to bring orphan drugs to market. As of March 31, 2020, the company has collaborated with 39 pharmaceutical partners covering more than forty-five 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 more information, please refer to the Risk Factors segment of our Annual Report for the year ended December 31, 2019 on Form 20-F filed with the SEC on April 23, 2020 and other existing reports and documents filed with the U.S. Stock Exchange. . Commission (SEC). You can download those documents by visiting EDGAR in the SEC at www.sec.gov.