Cambridge, MA, USA & Rostock\/Berlin, Germany, July 2, 2020 (GLOBE NEWSWIRE) \u2013 Centogene N.V. (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, today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 RT-PCR test.<\/p>\n
Prof. Arndt Rolfs, CEO of CENTOGENE, said, \u201cOver the past several months, we have been working tirelessly to ensure that we provide the best possible molecular diagnostic testing to prevent the further outbreak of COVID-19 and support the return to a new normal. This authorization by the FDA is another milestone for our COVID-19 testing efforts that validates the quality, precision and reliability of our tests.\u201d<\/p>\n
\u201cCENTOGENE is proud to have received this accelerated authorization from the FDA, which recognizes our continued commitment to the highest quality standards amid this global pandemic,\u201d said Ellen Karges, SVP Regulatory Compliance & Quality Management. \u201cMolecular testing is vital in diagnosing patients as early as possible, and we are confident that our test will support a successful fight against this novel outbreak especially in collaboration with our pharmaceutical partners, educational organizations and airports.\u201d<\/p>\n
CENTOGENE\u2019S SARS-CoV-2 RT-PCR test is a real-time test based on the reverse transcription polymerase chain reaction (RT-PCR) for the qualitative detection of SARS-CoV-2, the underlying virus causing COVID-19. It is intended to be used with samples of the upper respiratory tract (oropharyngeal swabs) collected from individuals suspected by their healthcare provider to have COVID-19, belonging to a risk cohort, or having been in contact with a confirmed COVID-19 patient.<\/p>\n
The test is intended for use by qualified laboratory personnel to be performed in CENTOGENE\u2019s CLIA certified high-complexity laboratories in Germany.<\/p>\n
CENTOGENE zajmuje si\u0119 diagnostyk\u0105 i badaniami nad chorobami rzadkimi, przekszta\u0142caj\u0105c rzeczywiste dane kliniczne i genetyczne w praktyczne informacje dla pacjent\u00f3w, lekarzy i firm farmaceutycznych. Naszym celem jest racjonalizacja decyzji terapeutycznych i przyspieszenie rozwoju nowych lek\u00f3w sierocych, wykorzystuj\u0105c nasz\u0105 rozleg\u0142\u0105 wiedz\u0119 na temat chor\u00f3b rzadkich, w tym dane epidemiologiczne i kliniczne, a tak\u017ce innowacyjne biomarkery. CENTOGENE opracowa\u0142o globaln\u0105, autorsk\u0105 platform\u0119 chor\u00f3b rzadkich opart\u0105 na naszym repozytorium danych z rzeczywistego \u015bwiata, obejmuj\u0105cym oko\u0142o 3 miliardy wa\u017conych punkt\u00f3w danych od ponad 530 000 pacjent\u00f3w z ponad 120 kraj\u00f3w (stan na 31 marca 2020 r.).<\/p>\n
Platforma firmy obejmuje dane epidemiologiczne, fenotypowe i genetyczne, kt\u00f3re odzwierciedlaj\u0105 globaln\u0105 populacj\u0119, a tak\u017ce biobank pr\u00f3bek krwi tych pacjent\u00f3w. CENTOGENE uwa\u017ca, \u017ce jest to jedyna platforma, kt\u00f3ra kompleksowo analizuje dane wielopoziomowe w celu lepszego zrozumienia rzadkich chor\u00f3b dziedzicznych, co mo\u017ce pom\u00f3c w identyfikacji pacjent\u00f3w i usprawni\u0107 wprowadzanie lek\u00f3w sierocych na rynek przez naszych partner\u00f3w farmaceutycznych. Na dzie\u0144 31 marca 2020 r. firma wsp\u00f3\u0142pracowa\u0142a z 39 partnerami farmaceutycznymi, obejmuj\u0105cymi ponad 45 r\u00f3\u017cnych chor\u00f3b rzadkich.<\/p>\n
This press release contains statements that constitute \u201cforward looking statements\u201d as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company\u2019s 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 \u201canticipate,\u201d \u201cintend,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cplan,\u201d \u201cseek,\u201d \u201cproject\u201d or \u201cexpect,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201ccould\u201d or \u201cshould,\u201d the negative of these terms or similar expressions. Forward looking statements are based on management\u2019s 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\u2019s 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 na stronie internetowej SEC.<\/a><\/p>\n CENTOGENECENTOGENE Contact<\/h5>\n
Sun Kim
Dyrektor ds. strategii i relacji inwestorskich
invest.relations(at)centogene(dot)com<\/a><\/p>\nKontakt dla medi\u00f3w<\/h5>\n