{"id":799482,"date":"2025-01-10T08:03:10","date_gmt":"2025-01-10T13:03:10","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/"},"modified":"2025-01-10T08:03:10","modified_gmt":"2025-01-10T13:03:10","slug":"revvity-announces-fda-clearance-for-first-automated-free-testosterone-test","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/","title":{"rendered":"Revvity Announces FDA Clearance for First Automated Free Testosterone Test"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Revvity Announces FDA Clearance for First Automated Free Testosterone Test<\/b><\/p>\n<p>WALTHAM, Mass.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.revvity.com&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=Revvity%2C+Inc.&amp;index=1&amp;md5=ef50bc64e70c516facc475f557000819\">Revvity, Inc.<\/a> (NYSE: RVTY), today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN\u2019s automated chemiluminescence-based immunoassay (ChLIA) <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.euroimmun.us%2Fproducts%2Fantigen%2Fsex-hormone-disorders%2FChLIA%2F&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=test&amp;index=2&amp;md5=ce5008e4c413df57bb6e4c2f52c8aec4\">test<\/a> for free testosterone. This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels, marking a significant advancement in diagnostic capabilities for androgen disorders.<\/p>\n<p><b>Key features of the new test include:<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThe only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma.<\/p>\n<\/li>\n<li>\nRapid results on EUROIMMUN\u2019s ChLIA platforms with the first result available in just 48 minutes and an estimated throughput of nearly 60 tests per hour.<\/p>\n<\/li>\n<li>\nIncorporation of monoclonal antibodies to ensure specificity and consistent performance across test batches.<\/p>\n<\/li>\n<\/ul>\n<p>\nThe state-of-the-art assay is processed on the Company\u2019s random-access <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.idsplc.com%2Finstruments%2Fisys%2F&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=iSYS&amp;index=3&amp;md5=b6a64ce937b91674dd8c437b79661d44\">iSYS<\/a><sup>TM<\/sup> or <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.idsplc.com%2Finstruments%2Fi10%2F&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=i10&amp;index=4&amp;md5=1cebc5c7e33e0254b0565cf748186f17\">i10<\/a><sup> TM<\/sup> instruments to deliver quick turnaround times and high-throughput testing with minimal technician training and expertise, while maintaining superior accuracy and reliability. The assay provides direct measurement of free testosterone levels in a single test, enhancing diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes.<\/p>\n<p>\n&#8220;Laboratory customers have been asking for a user-friendly FDA-cleared test, on a random-access platform, for direct measurement of free testosterone,&#8221; said Jonathan Friend, general manager at Revvity\u2019s EUROIMMUN US. &#8220;This clearance reinforces our commitment to expanding the FDA-cleared menu for the EUROIMMUN family of ChLIA automation solutions with assays that serve diverse patient populations across all demographics.\u201d<\/p>\n<p>\nFor more information about EUROIMMUN and its diagnostic solutions, please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.euroimmun.us&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=this+webpage&amp;index=5&amp;md5=a430ba9d5d2c712c0ad5adbc981ddc52\">this webpage<\/a>.<\/p>\n<p><b>About Revvity<\/b><\/p>\n<p>\nAt Revvity, \u201cimpossible\u201d is inspiration, and \u201ccan\u2019t be done\u201d is a call to action. Revvity provides health science solutions, technologies, expertise, and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what\u2019s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.<\/p>\n<p>\nWith 2023 revenue of more than $2.7 billion and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&amp;P 500 index and has customers in more than 190 countries.<\/p>\n<p>\nStay updated by following our <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fnews.revvity.com%2F&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=Newsroom&amp;index=6&amp;md5=bf30b576ab9b1c499ab0c0a37f219b44\">Newsroom<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Frevvity%2F&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=7&amp;md5=cdf51cdba6178db1b1bdd4a38ac7cd31\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FRevvityInc&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=X&amp;index=8&amp;md5=93799e8570b6fbe9a028f6f0d8bd8807\">X<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.youtube.com%2Fchannel%2FUCUqLrqOpUUwhz3UaLn78tVQ&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=YouTube&amp;index=9&amp;md5=392f2c95eec3455e0079a1547225995a\">YouTube<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FRevvityInc&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=Facebook&amp;index=10&amp;md5=393f4b4b3e7c0e1c87ae130e8ff700d6\">Facebook<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Frevvity%2F&amp;esheet=54175493&amp;newsitemid=20250109821344&amp;lan=en-US&amp;anchor=Instagram&amp;index=11&amp;md5=d1c19400faede3af21582051dd11c239\">Instagram<\/a>.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250109821344r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20250109821344\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20250109821344\/en\/<\/a><\/span><\/p>\n<p><b>Investor Relations:<br \/>\n<\/b><br \/>Steve Willoughby<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:steve.willoughby@revvity.com\">steve.willoughby@revvity.com<br \/>\n<\/a><\/p>\n<p><b>Media Relations:<br \/>\n<\/b><br \/>Chet Murray<br \/>\n<br \/>(781) 462-5126<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:chet.murray@revvity.com\">chet.murray@revvity.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Massachusetts United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology FDA Medical Devices Health Pharmaceutical<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250109821344\/en\/1801356\/3\/rev_logo_rgb_black_%282%29.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Revvity Announces FDA Clearance for First Automated Free Testosterone Test WALTHAM, Mass.&#8211;(BUSINESS WIRE)&#8211;Revvity, Inc. (NYSE: RVTY), today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN\u2019s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels, marking a significant advancement in diagnostic capabilities for androgen disorders. Key features of the new test include: The only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma. Rapid results on EUROIMMUN\u2019s ChLIA platforms with the first result available in just 48 minutes and an estimated throughput of nearly 60 tests per &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Revvity Announces FDA Clearance for First Automated Free Testosterone Test&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-799482","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Revvity Announces FDA Clearance for First Automated Free Testosterone Test - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Revvity Announces FDA Clearance for First Automated Free Testosterone Test - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Revvity Announces FDA Clearance for First Automated Free Testosterone Test WALTHAM, Mass.&#8211;(BUSINESS WIRE)&#8211;Revvity, Inc. (NYSE: RVTY), today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN\u2019s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels, marking a significant advancement in diagnostic capabilities for androgen disorders. Key features of the new test include: The only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma. Rapid results on EUROIMMUN\u2019s ChLIA platforms with the first result available in just 48 minutes and an estimated throughput of nearly 60 tests per &hellip; Continue reading &quot;Revvity Announces FDA Clearance for First Automated Free Testosterone Test&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-01-10T13:03:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250109821344r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Revvity Announces FDA Clearance for First Automated Free Testosterone Test\",\"datePublished\":\"2025-01-10T13:03:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\\\/\"},\"wordCount\":445,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20250109821344r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\\\/\",\"name\":\"Revvity Announces FDA Clearance for First Automated Free Testosterone Test - 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(NYSE: RVTY), today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN\u2019s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone. This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels, marking a significant advancement in diagnostic capabilities for androgen disorders. Key features of the new test include: The only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma. Rapid results on EUROIMMUN\u2019s ChLIA platforms with the first result available in just 48 minutes and an estimated throughput of nearly 60 tests per &hellip; Continue reading \"Revvity Announces FDA Clearance for First Automated Free Testosterone Test\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/","og_site_name":"Market Newsdesk","article_published_time":"2025-01-10T13:03:10+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250109821344r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Revvity Announces FDA Clearance for First Automated Free Testosterone Test","datePublished":"2025-01-10T13:03:10+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/"},"wordCount":445,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250109821344r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/revvity-announces-fda-clearance-for-first-automated-free-testosterone-test\/","name":"Revvity Announces FDA Clearance for First Automated Free Testosterone Test - 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