{"id":47068,"date":"2022-08-09T06:01:40","date_gmt":"2022-08-09T04:01:40","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/abionic-receives-ivdr-certification-for-its-predictive-ultra-rapid-sepsis-test-allowing-the-management-of-antibiotic-administration\/"},"modified":"2022-08-09T06:01:40","modified_gmt":"2022-08-09T04:01:40","slug":"abionic-receives-ivdr-certification-for-its-predictive-ultra-rapid-sepsis-test-allowing-the-management-of-antibiotic-administration","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/abionic-receives-ivdr-certification-for-its-predictive-ultra-rapid-sepsis-test-allowing-the-management-of-antibiotic-administration\/","title":{"rendered":"Abionic Receives IVDR Certification for Its Predictive Ultra-Rapid Sepsis Test Allowing the Management of Antibiotic Administration"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nBSI certification agency has granted Abionic\u2019s abioSCOPE\u00ae device and PSP test the IVDR certification for in-vitro diagnostics.\n<\/li>\n<li>\nThis certification complies with Europe\u2019s new In-vitro Diagnostic Regulation (IVDR), and will be required for products sold within the EU from May 2022 onward. A transitional regulation allows established, non-IVDR-certified products to be sold and used if they entered the EU before May 2022.\n<\/li>\n<li>\nPancreatic Stone Protein (PSP) on the abioSCOPE\u00ae is the earliest marker of sepsis, allowing for its identification up to 72 hours before the standard of care in 5 minutes.\n<\/li>\n<li>\nThe newly IVDR certified PSP test is particularly useful for guiding physicians in the decision to start or modify antibiotic treatment.\n<\/li>\n<\/ul>\n<p>LAUSANNE, Switzerland&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/AMR?src=hash\" target=\"_blank\" rel=\"noopener\">#AMR<\/a>&#8211;Abionic SA, a developer of disruptive nanotechnology-based diagnostic solutions, has announced that its Pancreatic Stone Protein (PSP) test on the abioSCOPE\u00ae has been certified by BSI certification agency as complying with the European In-vitro Diagnostic Regulation (IVDR), EU 2017\/746. This certification granted by notified bodies like BSI is required for in-vitro diagnostics to continue being sold in the European Union. The IVDR\u2019s extensive requirements were adopted by the European Parliament in 2017 and must now be implemented by May 26, 2022.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220808005159\/en\/1537051\/5\/D4bcdalb_190507_ABIONIC_0516_JGA.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220808005159\/en\/1537051\/21\/D4bcdalb_190507_ABIONIC_0516_JGA.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20220808005159\/en\/1537050\/5\/D4labda_100116_Logo_01_NDU.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220808005159\/en\/1537050\/21\/D4labda_100116_Logo_01_NDU.jpg\"><\/a><\/p>\n<p>\nIVDR becomes mandatory as of May 26, 2022. There are also transitional rules that will allow well-established instruments that have not been IVDR certified, but that entered the EU before, to still be sold until 2025. Depending on their shelf life, they may also be used after 2025. Abionic has been preparing for IVDR compliance since 2019, and chose BSI, a reputable notified body that was authorized to perform this certification process.\n<\/p>\n<p>\n\u201cAs part of its ongoing commitment to meeting the highest standards to ensure patient safety and meet customer needs, Abionic is proud to have achieved the required IVDR certification for its class C product,\u201d stated Dr. Iwan M\u00e4rki, CTO of Abionic.\n<\/p>\n<p>\n<b>Improving the management of antibiotic administration<\/b>\n<\/p>\n<p>\nAntibiotics are medicines that are used to prevent and treat bacterial infections, which have revolutionized healthcare since the 1930s and have been paramount in saving millions of lives. However, a systematic overuse and misuse of antibiotics is leading to a concerning increase in the number of antibiotic resistant bacteria, which are becoming harder to treat and causing more severe and fatal infections. International and national healthcare organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) have identified antibiotic resistance as one of the biggest threats to global health today. The over-prescription of antibiotics by healthcare workers is a key contributing factor leading to resistance, with a direct relationship between antibiotic consumption and the emergence and dissemination of resistant bacteria strains (Nature. 2013:495(7440):141). Studies have shown that antibiotic therapy is incorrectly prescribed in as many as 60% of patients receiving hospital care and is likely to be even higher outside this environment (Luyt et al., Critical Care, 2014). Aside from contributing to resistance, inappropriate antibiotic use may lead to increased mortality and severe disease, increased healthcare costs, increased lengths of stay in hospital and the need for more complex treatments leading to a higher risk for adverse effects and unwanted drug interactions.\n<\/p>\n<p>\nDr. Samir Vora, infectious disease physician, Geneva, Switzerland, commented: \u201cThe PSP assay has the potential to help the physician decide whether or not to start antibiotic therapy, and thus contribute to reducing the two major public health problems of sepsis and antimicrobial resistance.\u201d\n<\/p>\n<p>\nTwo years after the commercial launch of its sepsis test, Abionic\u2019s expansion is reaching a global scale. With over 50 markets already covered, Abionic\u2019s next big step is the U.S. where sepsis represents the single largest cost to the healthcare system. Clinical trials to support FDA 510(k) submission are well underway. \u201cAs we gear up for FDA clearance, it\u2019s very motivating to see how excited the U.S. ecosystem is about our novel approach to detecting sepsis and its potential impact on lifespan and healthcare costs,\u201d said Nelson Dumas, Director of the U.S. Subsidiary of Abionic.\n<\/p>\n<p>\n<b>About Abionic<\/b>\n<\/p>\n<p>\nFounded in 2010, Abionic is a Swiss Medtech company commercializing a revolutionary nanofluidic technology, providing healthcare professionals with a fast, simple and universal diagnostic tool. Abionic\u2019s cutting-edge nanotechnology enhances the efficiency and versatility of standard ELISA tests to deliver optimal point of care (POC) treatment options by reducing current biological measuring techniques from the macroscale down to the nanoscale in a multi-analyte environment.\n<\/p>\n<p>\nAbionic\u2019s In Vitro Diagnostic (IVD) platform provides lab-quality ultra-fast results from a single drop of patient sample (saliva, blood, urine, etc.) at the POC enabling personalized diagnostics and opening the window of opportunity for immediate treatment. The company is mainly active in acute care and in primary care (COVID-19, allergy, iron deficiency) businesses.\n<\/p>\n<p>\nFor further information about Abionic, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.abionic.com%2F&amp;esheet=52804239&amp;newsitemid=20220808005159&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.abionic.com%2F&amp;index=1&amp;md5=0e85f8e9edcacdf86047a41f25296cd6\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.abionic.com\/<\/a>.<br \/>\n<br \/>For further information about IVDR, please visit: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Feur-lex.europa.eu%2Flegal-content%2FEN%2FTXT%2F%3Furi%3DCELEX%253A02017R0746-20170505&amp;esheet=52804239&amp;newsitemid=20220808005159&amp;lan=en-US&amp;anchor=EUR-Lex&amp;index=2&amp;md5=432691e7e131e48f1b6bb26b8300469b\" rel=\"nofollow noopener\" shape=\"rect\">EUR-Lex<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nDr. Nicolas Durand<br \/>\n<br \/>CEO<br \/>\n<br \/>Abionic SA<br \/>\n<br \/>+41 (0)21 353 33 80<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#x69;l&#x74;o&#x3a;i&#x6e;&#102;&#x6f;&#64;&#x61;&#98;&#x69;&#111;n&#105;c&#x2e;c&#x6f;m\" rel=\"nofollow noopener\" shape=\"rect\">i&#110;&#102;&#x6f;&#x40;&#x61;b&#105;&#111;&#x6e;&#x69;&#x63;&#46;c&#111;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>BSI certification agency has granted Abionic\u2019s abioSCOPE\u00ae device and PSP test the IVDR certification for in-vitro diagnostics. This certification complies with Europe\u2019s new In-vitro Diagnostic Regulation (IVDR), and will be required for products sold within the EU from May 2022 onward. A transitional regulation allows established, non-IVDR-certified products to be sold and used if they &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/abionic-receives-ivdr-certification-for-its-predictive-ultra-rapid-sepsis-test-allowing-the-management-of-antibiotic-administration\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47068","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Abionic Receives IVDR Certification for Its Predictive Ultra-Rapid Sepsis Test Allowing the Management of Antibiotic Administration - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/abionic-receives-ivdr-certification-for-its-predictive-ultra-rapid-sepsis-test-allowing-the-management-of-antibiotic-administration\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Abionic Receives IVDR Certification for Its Predictive Ultra-Rapid Sepsis Test Allowing the Management of Antibiotic Administration - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BSI certification agency has granted Abionic\u2019s abioSCOPE\u00ae device and PSP test the IVDR certification for in-vitro diagnostics. 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This certification complies with Europe\u2019s new In-vitro Diagnostic Regulation (IVDR), and will be required for products sold within the EU from May 2022 onward. A transitional regulation allows established, non-IVDR-certified products to be sold and used if they ... 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