{"id":32399,"date":"2025-11-12T22:21:08","date_gmt":"2025-11-12T22:21:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/us-pa\/32399\/"},"modified":"2025-11-12T22:21:08","modified_gmt":"2025-11-12T22:21:08","slug":"life-sciences-company-well-known-in-lehigh-valley-announces-major-fda-approval-business-news","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us-pa\/32399\/","title":{"rendered":"Life sciences company well known in Lehigh Valley announces major FDA approval | Business News"},"content":{"rendered":"<p>WALTHAM, Mass. &#8211;\u00a0Thermo Fisher Scientific has cleared a major regulatory hurdle in getting a new diagnostic tool for a type of blood cancer in the hands of doctors.<\/p>\n<p>The Massachusetts-based life sciences company, with locations in the Lehigh Valley that include Upper Saucon, East Allen, and Upper Macungie townships, said it has received\u00a0510(k) clearance for its\u00a0EXENT System to be used in the diagnosis of\u00a0multiple myeloma.<\/p>\n<p>The clearance, granted by the Food and Drug Administration (FDA), means the <a href=\"https:\/\/www.thermofisher.com\/bindingsite\/us\/en\/products\/instruments\/exent-system.html\" target=\"_blank\" rel=\"nofollow noopener\">EXENT System<\/a> is now available for clinical use in the U.S.<\/p>\n<p>                        <img loading=\"lazy\" decoding=\"async\" src=\"data:image\/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAQAAAADCAQAAAAe\/WZNAAAAEElEQVR42mM8U88ABowYDABAxQPltt5zqAAAAABJRU5ErkJggg==\" alt=\"exent system 1.png\" class=\"img-responsive lazyload full blur\" width=\"576\" height=\"512\" data- data-\/><\/p>\n<p>             <img decoding=\"async\" src=\"https:\/\/www.newsbeep.com\/us-pa\/wp-content\/uploads\/2025\/11\/69150336a51d2.image.png\" alt=\"\" aria-hidden=\"true\" loading=\"lazy\" height=\"178\" width=\"200\"\/><\/p>\n<p>                                    Credit: Thermo Fisher<\/p>\n<p>Thermo Fisher described EXENT as a first-of-its-kind automated platform that is designed to detect abnormal antibodies produced by cancerous plasma cells at low concentrations, which could result in a faster diagnosis for patients.<\/p>\n<p>The company said\u00a0more than 176,000 people are diagnosed with multiple myeloma worldwide each year. It&#8217;s a type of cancer that affects plasma cells in bone marrow.<\/p>\n<p>\u201cOur continued goal is to equip laboratories and clinicians with technologies that deliver greater accuracy, efficiency and clarity, enabling more informed clinical decisions and improving the patient journey,\u201d said Stephen Harding, vice president and general manager, protein diagnostics, Thermo Fisher Scientific, in a news release. \u201cThe EXENT System reflects Thermo Fisher\u2019s commitment to advancing diagnostic solutions that meet well-defined clinical needs.\u201d<\/p>\n<p>The EXENT System also is approved for use in other parts of the world, like Canada, Australia, the United Kingdom, the Netherlands and Brazil.<\/p>\n<p>Thermo Fisher calls itself the world leader in serving science, with annual revenue over $40 billion. It&#8217;s a global company that makes a wide variety of products, equipment and services for scientific research and clinical diagnostics.<\/p>\n","protected":false},"excerpt":{"rendered":"WALTHAM, Mass. &#8211;\u00a0Thermo Fisher Scientific has cleared a major regulatory hurdle in getting a new diagnostic tool for&hellip;\n","protected":false},"author":2,"featured_media":32400,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[119,121,120,20407,20395,20400,20405,3765,9328,20392,20399,20408,17457,17458,13428,6560,11276,20394,157,20393,9985,10369,20398,20404,20403,20401,20396,20397,66,20402,20406],"class_list":["post-32399","post","type-post","status-publish","format-standard","has-post-thumbnail","category-allentown","tag-allentown","tag-allentown-headlines","tag-allentown-news","tag-antibodies","tag-australia","tag-blood-cancer","tag-brazil","tag-canada","tag-cancer","tag-central-railroad-of-new-jersey","tag-diagnostic-solutions","tag-diagnostic-tool","tag-fda","tag-food-and-drug-administration","tag-leader","tag-lehigh","tag-lehigh-division","tag-lehigh-gap","tag-lehigh-valley","tag-lehigh-valley-railroad","tag-major","tag-massachusetts","tag-multiple-myeloma","tag-netherlands","tag-protein-diagnostics","tag-stephen-harding","tag-thermo-fisher-scientific","tag-united-kingdom","tag-united-states","tag-vice-president-and-general-manager","tag-waltham"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts\/32399","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/comments?post=32399"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts\/32399\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/media\/32400"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/media?parent=32399"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/categories?post=32399"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/tags?post=32399"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}