{"id":2228,"date":"2022-05-25T00:00:00","date_gmt":"2022-05-25T00:00:00","guid":{"rendered":"http:\/\/centogene.vl22350.dinaserver.com\/2228"},"modified":"2022-05-25T00:00:00","modified_gmt":"2022-05-25T00:00:00","slug":"centogenes-centocloud-is-now-ce-marked-as-one-of-the-only-decentralized-saas-platforms-compliant-with-european-ivd-regulatory-framework","status":"publish","type":"post","link":"https:\/\/www.centogene.com\/pl\/centogenes-centocloud-is-now-ce-marked-as-one-of-the-only-decentralized-saas-platforms-compliant-with-european-ivd-regulatory-framework\/","title":{"rendered":"Platforma CentoCloud\u00ae firmy CENTOGENE uzyska\u0142a ju\u017c oznaczenie CE jako jedna z nielicznych zdecentralizowanych platform SaaS zgodnych z europejskimi ramami regulacyjnymi IVD"},"content":{"rendered":"<h2 class=\"h3\">Platforma wspomagaj\u0105ca podejmowanie decyzji klinicznych oznaczona znakiem CE umo\u017cliwia laboratoriom dostarczanie najlepszej w swojej klasie diagnostyki chor\u00f3b genetycznych<\/h2>\n<ul>\n<li>CentoCloud, CENTOGENE\u2019s cloud-based Software as a Service (SaaS) platform, is CE-marked under the In Vitro Diagnostics Directive (98\/79\/EC)<\/li>\n<li>CE-marking is required for all in vitro diagnostic (IVD) devices to be placed 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<\/li>\n<li>CentoCloud is one of the world\u2019s only CE-marked IVD software for genomic diagnostics; Considering the change in the European regulatory landscape with new In Vitro Diagnostic Regulation (IVDR 2017\/746) taking full effect on May 26, 2022, this underlines CENTOGENE\u2019s commitment to meeting the highest industry standards<\/li>\n<\/ul>\n<p> <strong>CAMBRIDGE, Mass., ROSTOCK, Germany and BERLIN, May 25, 2022 (GLOBE NEWSWIRE)<\/strong> \u2013 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).<\/p>\n<p>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\u2019s fully automated bioinformatics pipeline analyzes NGS data based on CENTOGENE\u2019s validated testing products, annotated with data from the CENTOGENE Biodatabank.<\/p>\n<p>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&#8217;s new In Vitro Diagnostic Regulation (IVDR 2017\/746) will take full effect on May 26, 2022.<\/p>\n<p>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\u2019s only CE-marked IVD software for genomic diagnostics that is available via the cloud.<\/p>\n<p>\u201cAt CENTOGENE, we are committed to enabling access to genetic testing for patients around world,\u201d said Kim Stratton, CEO of CENTOGENE. \u201cWith the new IVD regulation going into place later this week, CentoCloud will be one of Europe\u2019s only commercialized software on the market \u2013 underlining our commitment to being at the forefront of offering safe and accessible patient solutions.\u201d<\/p>\n<p>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: <a href=\"t3:\/\/page?uid=3057\" title=\"Learn more about CentoCloud\">https:\/\/www.centogene.com\/diagnostics\/centocloud<\/a><\/p>\n<h3>O firmie CENTOGENE<\/h3>\n<p>CENTOGENE zajmuje si\u0119 diagnostyk\u0105 i badaniami nad chorobami rzadkimi, przekszta\u0142caj\u0105c rzeczywiste dane kliniczne, genetyczne i multiomiczne w celu diagnozowania, zrozumienia i leczenia chor\u00f3b rzadkich. Naszym celem jest racjonalizacja decyzji terapeutycznych i przyspieszenie rozwoju nowych lek\u00f3w sierocych poprzez wykorzystanie naszej rozleg\u0142ej wiedzy i danych na temat chor\u00f3b rzadkich. CENTOGENE opracowa\u0142o globaln\u0105, autorsk\u0105 platform\u0119 bada\u0144 nad chorobami rzadkimi, opart\u0105 na naszym repozytorium danych dotycz\u0105cych chor\u00f3b rzadkich, obejmuj\u0105cym ponad 650 000 os\u00f3b z ponad 120 kraj\u00f3w.<\/p>\n<p>Platforma firmy obejmuje dane epidemiologiczne, fenotypowe i genetyczne, kt\u00f3re odzwierciedlaj\u0105 globaln\u0105 populacj\u0119, a tak\u017ce biobank pr\u00f3bek krwi pacjent\u00f3w i kultur kom\u00f3rkowych. CENTOGENE uwa\u017ca, \u017ce jest to jedyna platforma skoncentrowana na kompleksowej analizie danych wielopoziomowych w celu lepszego zrozumienia rzadkich chor\u00f3b dziedzicznych. Umo\u017cliwia ona lepsz\u0105 identyfikacj\u0119 i stratyfikacj\u0119 pacjent\u00f3w oraz ich chor\u00f3b podstawowych, co umo\u017cliwia i przyspiesza odkrywanie, rozw\u00f3j i dost\u0119p do lek\u00f3w sierocych. Na dzie\u0144 31 grudnia 2021 r. firma wsp\u00f3\u0142pracowa\u0142a z ponad 30 partnerami farmaceutycznymi.<\/p>\n<p>Obserwuj nas na <a href=\"https:\/\/de.linkedin.com\/company\/centogene\" target=\"_blank\" title=\"Link do LinkedIn\">LinkedIn<\/a>.<\/p>\n<h3>O\u015bwiadczenia prognostyczne<\/h3>\n<p>This press release contains \u201cforward-looking statements\u201d 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 \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinues,\u201d \u201cexpect,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cproject,\u201d and similar expressions and future or conditional verbs such as \u201cwill,\u201d \u201cwould,\u201d \u201cshould,\u201d \u201ccould,\u201d \u201cmight,\u201d \u201ccan,\u201d and \u201cmay,\u201d 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\u2019s 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\u2019s business in general, see CENTOGENE\u2019s risk factors set forth in CENTOGENE\u2019s Form 20-F filed on March 30, 2022, with the Securities and Exchange Commission (the \u201cSEC\u201d) and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and CENTOGENE\u2019s specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.<\/p>\n<h4 class=\"h3\">Kontakt dla medi\u00f3w<\/h4>\n<h5>CENTOGENE<\/h5>\n<p>Ben Legg<br \/> Komunikacja korporacyjna&nbsp;<br \/> <a href=\"mailto:press@centogene.com\" title=\"Napisz e-mail\">press(at)centogene(dot)com<\/a><\/p>\n<p>Lennart Streibel<br \/> Relacje inwestorskie<br \/> <a href=\"mailto:investor.relations@centogene.com\" title=\"Napisz e-mail\">investor.relations(at)centogene(dot)com <\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Platforma wspomagaj\u0105ca podejmowanie decyzji klinicznych oznaczona znakiem CE umo\u017cliwia laboratoriom dostarczanie najlepszej w swojej klasie diagnostyki chor\u00f3b genetycznych<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2228","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CENTOGENE\u2019s CentoCloud\u00ae Is Now CE-Marked as One of the Only Decentralized SaaS Platforms Compliant With European IVD Regulatory Framework | CENTOGENE<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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