{"id":2180,"date":"2010-11-23T15:19:57","date_gmt":"2010-11-23T20:19:57","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=2180"},"modified":"2010-11-23T15:24:05","modified_gmt":"2010-11-23T20:24:05","slug":"fda-clears-protein-test-for-heart-failure-prognosis","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=2180","title":{"rendered":"FDA Clears Protein Test for Heart Failure Prognosis"},"content":{"rendered":"<figure id=\"attachment_105\" aria-describedby=\"caption-attachment-105\" style=\"width: 200px\" class=\"wp-caption alignright\"><a href=\"http:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2010\/07\/HumanHeartArteries_YaleMedicineWMC_200x250.png\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-105\" title=\"HumanHeartArteries_YaleMedicineWMC_200x250\" src=\"http:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2010\/07\/HumanHeartArteries_YaleMedicineWMC_200x250.png\" alt=\"Human heart and arteries (Yale School of Medicine\/Wikimedia Commons)\" width=\"200\" height=\"249\" srcset=\"https:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2010\/07\/HumanHeartArteries_YaleMedicineWMC_200x250.png 200w, https:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2010\/07\/HumanHeartArteries_YaleMedicineWMC_200x250-120x150.png 120w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/><\/a><figcaption id=\"caption-attachment-105\" class=\"wp-caption-text\">(Yale School of Medicine\/Wikimedia Commons)<\/figcaption><\/figure>\n<p>BG Medicine Inc., a Waltham, Massacusetts developer of molecular diagnostics using biomarkers, says that the U.S. Food and Drug Administration (FDA) has <a href=\"http:\/\/www.galectin-3.com\/?p=2102\">cleared the company&#8217;s galectin-3 test<\/a> to help assess the prognosis of patients diagnosed with chronic heart failure. The company says this 510(k) clearance is the first time FDA has cleared a test to measure galectin-3 blood levels.<\/p>\n<p>Galectin-3 is a protein that has been shown to play a role in the development and progression of heart failure in about 30 percent of the patients diagnosed with the disease. This galectin-3 mediated form of heart failure is associated with progressive fibrosis, or stiffening, in the heart muscle, which impairs the heart&#8217;s ability to pump. The <a href=\"http:\/\/circ.ahajournals.org\/cgi\/content\/short\/110\/19\/3121\">role of galectin-3 in heart failure<\/a> was first established in 2004, and the company&#8217;s galectin-3 blood test allows physicians to use this product to evaluate patients diagnosed with heart failure.<\/p>\n<p>A <a href=\"http:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/howtomarketyourdevice\/premarketsubmissions\/premarketnotification510k\/default.htm\">510(k)<\/a> is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device. Once the device is determined to be SE, it can then be marketed in the U.S.<\/p>\n<p>BG Medicine is finalizing its commercialization plans with clinical laboratory LabCorp, to make BG Medicine&#8217;s galectin-3 test available within 45 days of the FDA clearance. BG Medicine also has agreements with Abbott Laboratories, Alere Inc. , and bioM\u00e9rieux SA for the development and commercialization of automated versions of the galectin-3 test.<\/p>\n<p style=\"text-align: center;\">*\u00a0\u00a0\u00a0\u00a0 *\u00a0\u00a0\u00a0\u00a0 *<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BG Medicine Inc., a Waltham, Massacusetts developer of molecular diagnostics using biomarkers, says that the U.S. Food and Drug Administration (FDA) has cleared the company&#8217;s galectin-3 test to help assess the prognosis of patients diagnosed with chronic heart failure. The company says this 510(k) clearance is the first time FDA has cleared a test to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[31,21,22,77],"class_list":["post-2180","post","type-post","status-publish","format-standard","hentry","category-regulations","tag-biomedical","tag-biotech","tag-fda","tag-medical-device"],"_links":{"self":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/2180","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2180"}],"version-history":[{"count":4,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/2180\/revisions"}],"predecessor-version":[{"id":2183,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/2180\/revisions\/2183"}],"wp:attachment":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2180"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2180"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2180"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}