{"id":9413,"date":"2025-10-13T12:47:37","date_gmt":"2025-10-13T07:17:37","guid":{"rendered":"https:\/\/nationalvani.com\/en\/?p=9413"},"modified":"2025-10-13T12:47:37","modified_gmt":"2025-10-13T07:17:37","slug":"biolyticals-istatis-syphilis-antibody-test-now-included-in-the-australian-register-of-therapeutic-goods-artg","status":"publish","type":"post","link":"https:\/\/nationalvani.com\/en\/biolyticals-istatis-syphilis-antibody-test-now-included-in-the-australian-register-of-therapeutic-goods-artg\/","title":{"rendered":"bioLytical\u2019s iStatis Syphilis Antibody Test Now Included in the Australian Register of Therapeutic Goods (ARTG)"},"content":{"rendered":"<div class=\"natio-before-content\" style=\"margin-bottom: 12px;\" id=\"natio-3077889150\"><style>\r\n.ad {\r\ndisplay: block;\r\nmargin: 0 auto 12px;\r\nwidth: 100%;\r\nmax-width: 640px;\r\n}\r\n<\/style>\r\n<!-- <img class=\"ad\" src=\"\" alt=\"Ad\" \/> -->\r\n<img class=\"ad\" src=\"https:\/\/nationalvani.com\/wp-content\/uploads\/2026\/01\/Ad-GaneshJoshi.jpg\" alt=\"Ad\" \/>\r\n<img class=\"ad\" src=\"https:\/\/nationalvani.com\/wp-content\/uploads\/2026\/01\/Ad-NagarPalikaTehri.jpeg\" alt=\"Ad\" \/>\r\n<img class=\"ad\" src=\"https:\/\/nationalvani.com\/wp-content\/uploads\/2026\/01\/Ad-NagarNigamRishikesh.jpeg\" alt=\"Ad\" \/>\r\n<\/div><div class=\"adn ads\" data-message-id=\"#msg-f:1845818891895719870\" data-legacy-message-id=\"199daa80ab2647be\">\n<div class=\"gs\">\n<div class=\"\">\n<div id=\":mi\" class=\"ii gt\">\n<div id=\":mh\" class=\"a3s aiL \">\n<ul>\n<li style=\"text-align: justify;\"><em><span style=\"font-size: 22px;\">Expanding access to fast, accurate syphilis testing to support Australia\u2019s public health response<\/span><\/em><\/li>\n<\/ul>\n<section>\n<article>\n<p style=\"text-align: justify;\">Key Highlights<\/p>\n<ul style=\"text-align: justify;\" type=\"disc\">\n<li><em>The iStatis Syphilis Antibody Test is now included in the Australian Register of Therapeutic Goods (ARTG: 515126), available for professional use nationwide.<\/em><\/li>\n<li><em>Delivers accurate results in under 15 minutes, enabling screening in various healthcare settings.<\/em><\/li>\n<li><em>Manufactured under bioLytical\u2019s MDSAP ISO 13485:2016-certified Quality Management System.<\/em><\/li>\n<li><em>Designed to support Australia\u2019s ongoing efforts to reduce syphilis transmission and improve early diagnosis.<\/em><\/li>\n<li><em>Portable, reliable, and room-temperature stable for both laboratory and remote use.<\/em><\/li>\n<\/ul>\n<p style=\"text-align: justify;\" align=\"left\">RICHMOND, British Columbia:\u00a0 bioLytical Laboratories Inc. (\u201cbioLytical\u201d), a global leader in rapid diagnostic solutions, announces the inclusion of its iStatis Syphilis Antibody Test\u00a0in the\u00a0Australian Register of Therapeutic Goods (ARTG: 515126). This milestone enables the distribution of the test to healthcare professionals across Australia, strengthening national capacity for fast and reliable syphilis screening.<\/p>\n<p style=\"text-align: justify;\">\u201cWe are excited to announce that our iStatis Syphilis Antibody Test is now included in the ARTG,\u201d said Robert Mackie, CEO of bioLytical. \u201cAustralia, like many countries, continues to face rising syphilis rates, particularly in regions with limited access to regular healthcare. By providing an accurate, easy-to-use rapid test, we can support healthcare professionals in identifying infections earlier and connecting patients to treatment faster.\u201d<\/p>\n<p style=\"text-align: justify;\">Fast, Accurate, and Built for Accessibility<\/p>\n<p style=\"text-align: justify;\">The iStatis Syphilis Antibody Test is a lateral flow assay that detects antibodies to Treponema pallidum, the bacterium that causes syphilis. Using a small fingerstick blood sample, it provides results in under 15 minutes, helping healthcare providers make timely clinical decisions.<\/p>\n<p style=\"text-align: justify;\">Key Benefits<\/p>\n<ul style=\"text-align: justify;\" type=\"disc\">\n<li>Rapid Results:\u00a0Reliable, same-visit results in less than 15 minutes.<\/li>\n<li>High Accuracy:\u00a0Demonstrated strong sensitivity and specificity in clinical trials.<\/li>\n<li>Portable Design:\u00a0Shelf-stable at room temperature for use in outreach or clinical settings.<\/li>\n<li>Ease of Use:\u00a0Requires only a fingerstick blood sample; no complex equipment or cold storage required.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Why Rapid Syphilis Testing Matters<\/p>\n<ul style=\"text-align: justify;\" type=\"disc\">\n<li>In 2024, 5,866 syphilis diagnoses were recorded across Australia, roughly double the number from 10 years ago<\/li>\n<li>Congenital syphilis cases have more than doubled since 2015, with 34 infant deaths attributed to the disease in the past decade<\/li>\n<li>The Department of Health and Aged Care\u2019s national syphilis surveillance reports confirm that infectious syphilis notifications continue to rise across jurisdictions<\/li>\n<li>Syphilis remains a nationally notifiable disease under the National Disease Surveillance System (NNDSS)<\/li>\n<li>Because early infections are often asymptomatic,\u00a0accessible point-of-care testing\u00a0is essential for early detection and prevention.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Supporting Australia\u2019s Public Health Goals<\/p>\n<p style=\"text-align: justify;\">The inclusion of the iStatis Syphilis Antibody Test in the ARTG supports Australia\u2019s national strategy to expand testing and reduce sexually transmitted infections. By providing fast, reliable diagnostics,\u00a0bioLytical aims to strengthen early detection, accelerate treatment, and prevent transmission, particularly in underserved or remote regions.<\/p>\n<p style=\"text-align: justify;\">\u201c Every congenital case of syphilis is preventable with timely testing and treatment,\u201d said Ana Subramanian, Vice President of Scientific Affairs at bioLytical Laboratories. \u201cRapid, point-of-care solutions like the iStatis Syphilis Antibody Test are critical for expanding access to early diagnosis in both clinical and outreach settings, helping to protect maternal and infant health worldwide.&#8221;<\/p>\n<p style=\"text-align: justify;\">Manufactured in Canada under bioLytical\u2019s MDSAP and ISO 13485:2016-certified Quality Management System, the iStatis Syphilis Antibody Test is part of the company\u2019s growing iStatis<sup>\u00ae<\/sup> portfolio of rapid diagnostics. Each test is designed to deliver real-time, accurate results that improve patient outcomes and advance global public health goals. Healthcare professionals across Australia can access the test through authorized distributors or by contacting bioLytical directly. <em>CRDT: GLOBE NEWSWIRE<\/em><\/p>\n<\/article>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"natio-after-content\" style=\"margin-bottom: 12px;\" id=\"natio-463460744\"><style>\r\n.ad {\r\ndisplay: block;\r\nmargin: 0 auto 12px;\r\nwidth: 100%;\r\nmax-width: 640px;\r\n}\r\n<\/style>\r\n<!-- <img class=\"ad\" src=\"\" alt=\"Ad\" \/> -->\r\n<!-- <img class=\"ad\" src=\"\" alt=\"Ad\" \/> -->\r\n\r\n\n\t\t<!-- MasterSlider -->\n\t\t<div id=\"P_MS69da7608a9562\" class=\"master-slider-parent msl ms-parent-id-4\" style=\"max-width:640px;\">\n\n\t\t\t\n\t\t\t<!-- MasterSlider Main -->\n\t\t\t<div id=\"MS69da7608a9562\" class=\"master-slider ms-skin-default\" >\n\t\t\t\t \t\t\t\t \n\t\t\t\t<div  class=\"ms-slide\" data-delay=\"2\" data-fill-mode=\"stretch\"  >\n\t\t\t\t\t<img 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Delivers accurate results in under 15 minutes, enabling screening in various healthcare settings. Manufactured under bioLytical\u2019s MDSAP ISO &hellip;<\/p>\n","protected":false},"author":2,"featured_media":9414,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22,16],"tags":[2254],"class_list":["post-9413","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news","category-world-news","tag-biolyticals-istatis-syphilis-antibody-test-now-included-in-the-australian-register-of-therapeutic-goods-artg"],"_links":{"self":[{"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/posts\/9413","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/comments?post=9413"}],"version-history":[{"count":1,"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/posts\/9413\/revisions"}],"predecessor-version":[{"id":9415,"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/posts\/9413\/revisions\/9415"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/media\/9414"}],"wp:attachment":[{"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/media?parent=9413"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/categories?post=9413"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nationalvani.com\/en\/wp-json\/wp\/v2\/tags?post=9413"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}