- Offering includes delivery of a full, safe, and high-quality COVID-19 testing solution – significantly broadening access to the Company’s innovative tests
- Short process times and digital transmission of reports deliver results directly to the customer
- Tests validated on the basis of the World Health Organization’s (WHO)/Charité’s reference guidelines
Cambridge, MA, USA & Rostock/Berlin, Germany, July 23 2020 – 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 makes 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.”
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 here.
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.
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).
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.