{"id":84630,"date":"2020-10-14T12:38:00","date_gmt":"2020-10-13T18:20:00","guid":{"rendered":"https:\/\/hispanicprwire.com\/english-mir-scientific-announces-fda-breakthrough-device-designation-for-its-prostate-cancer-liquid-biopsy-test\/"},"modified":"2020-10-14T12:42:02","modified_gmt":"2020-10-14T16:42:02","slug":"mir-scientific-anuncia-designacion-de-dispositivo-innovador-por-parte-de-la-fda-para-su-examen-de-orina-de-biopsia-liquida-para-el-cancer-de-prostata","status":"publish","type":"post","link":"https:\/\/hispanicprwire.com\/en\/mir-scientific-anuncia-designacion-de-dispositivo-innovador-por-parte-de-la-fda-para-su-examen-de-orina-de-biopsia-liquida-para-el-cancer-de-prostata\/","title":{"rendered":"miR Scientific announces FDA Breakthrough Device Designation for its Prostate Cancer Liquid Biopsy Test"},"content":{"rendered":"<p><\/p>\n<style type=\"text\/css\"><![CDATA[\n\/* Style Definitions *\/\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n]]><\/style>\n<div class=\"xn-content\">\n<p><span class=\"xn-location\">NEW YORK<\/span>, <span class=\"xn-chron\">Oct. 13, 2020<\/span> \/PRNewswire-HISPANIC PR WIRE\/ &#8212;\u00a0<a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2948209-1&amp;h=2936714046&amp;u=https%3A%2F%2Fwww.mirscientific.com%2F&amp;a=miR+Scientific%2C+LLC\" rel=\"nofollow\">miR Scientific, LLC<\/a>, a healthcare company whose purpose is to transform global cancer management by providing early and highly accurate detection, characterization and monitoring of disease, announced today that it has received Breakthrough Device Designation by the U.S Food &amp; Drug Administration for its miR Sentinel\u2122 PCC4 Assay (miR Sentinel\u2122\u00a0Prostate Test).\u00a0 FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.\u00a0 <\/p>\n<div id=\"prni_dvprnejpg2a45left\" style=\"WIDTH: 100%; TEXT-ALIGN: left\" dir=\"ltr\"><img decoding=\"async\" id=\"prnejpg2a45left\" title=\" \" style=\"HEIGHT: 118px; WIDTH: 400px\" border=\"0\" alt=\" \" align=\"middle\" imagelabel=\"General\" src=\"https:\/\/mma.prnewswire.com\/media\/1273459\/miR_Scientific_Logo.jpg\"\/><\/div>\n<p>The Company&#8217;s miR Sentinel\u2122\u00a0Prostate Test is a new method to analyze small non-coding RNAs (sncRNA) derived from a simple, non-invasive urine specimen from age-eligible men. Using only the expression level of these sncRNAs, a proprietary Statistical Classification Algorithm derives scores that classify patients according to the likelihood of being in the following four possible groups: no molecular evidence of prostate cancer; low-risk; intermediate-risk; or high-risk prostate cancer. Initial validation data for the miR Sentinel\u2122 Prostate Test was published in the <span class=\"xn-chron\">September 2020<\/span> issue of\u00a0<i><a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2948209-1&amp;h=806924212&amp;u=https%3A%2F%2Fwww.auajournals.org%2Fdoi%2F10.1097%2FJU.0000000000001020&amp;a=The+Journal+of+Urology\" rel=\"nofollow\">The Journal of Urology<\/a><\/i>. The Company will initially commercialize its test as a Laboratory Developed Test in the US. Through the Breakthrough Device Program, miR Scientific will work more closely and frequently with the FDA to expedite its review of the miR Sentinel\u2122\u00a0Prostate Test. <\/p>\n<p>In comparison to currently available technologies alone, the specificity, sensitivity and empirical NPV and PPV of the miR Sentinel\u2122\u00a0Prostate Test may significantly reduce mortality and decrease the number of hospitalizations, physician visits and reduce recovery time. The Company designed the miR Sentinel\u2122\u00a0Prostate Test to revolutionize a patient&#8217;s disease journey when used by a provider in conjunction with other clinical findings and\/or laboratory tests. <\/p>\n<p>&#8220;We are highly appreciative that the FDA&#8217;s breakthrough designation process provided miR Scientific with invaluable feedback, which we have incorporated into our current clinical prospective studies to support our\u00a0full marketing authorization plan&#8221; said <span class=\"xn-person\">Sam Salman<\/span>, Chairman and CEO of miR Scientific.\u00a0 &#8220;Receiving this designation achieves another important milestone in the development of our novel and ground-breaking technology. We believe that the accuracy and non-invasive feature of our <a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2948209-1&amp;h=1492737202&amp;u=https%3A%2F%2Fwww.prnewswire.com%2Fnews-releases%2Fmir-scientifics-breakthrough-sentinel-disease-management-platform-receives-2020-innovation-award-301130117.html&amp;a=award-winning+technology\" rel=\"nofollow\">award-winning technology<\/a> will impact the lives of millions of men and forever positively change the standard of care for urological cancers&#8221;.<\/p>\n<p><b>About miR Scientific<\/b>: <a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2948209-1&amp;h=2936714046&amp;u=https%3A%2F%2Fwww.mirscientific.com%2F&amp;a=miR+Scientific%2C+LLC\" rel=\"nofollow\">miR Scientific, LLC<\/a>\u00a0is a healthcare company whose purpose is to transform global cancer management by providing early and highly accurate detection, characterization and monitoring of disease. Our team developed miR Scientific Disease Management Platform\u00e2, which is comprised of proprietary, non-invasive and highly accurate liquid biopsy urine tests for the detection, classification and monitoring of urological cancers.\u00a0The Platform is being utilized to commercialize its award-winning miR Sentinel\u2122\u00a0Prostate Test. miR Scientific is a majority-owned operating subsidiary of Impact NRS LLC, headquartered in\u00a0New York\u00a0City with operating subsidiaries in\u00a0Israel,\u00a0Canada\u00a0and\u00a0Puerto Rico.<\/p>\n<p>Logo &#8211; <a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2948209-1&amp;h=790490923&amp;u=https%3A%2F%2Fmma.prnewswire.com%2Fmedia%2F1273459%2FmiR_Scientific_Logo.jpg&amp;a=https%3A%2F%2Fmma.prnewswire.com%2Fmedia%2F1273459%2FmiR_Scientific_Logo.jpg\" rel=\"nofollow\">https:\/\/mma.prnewswire.com\/media\/1273459\/miR_Scientific_Logo.jpg<\/a><\/p>\n<p>\u00a0<\/p>\n<p>SOURCE  miR Scientific, LLC<\/p>\n<\/div>\n<p> <\/p>","protected":false},"excerpt":{"rendered":"<div class=\"xn-content\">\n<p><span class=\"xn-location\">NEW YORK<\/span>, <span class=\"xn-chron\">Oct. 13, 2020<\/span> \/PRNewswire-HISPANIC PR WIRE\/ &#8212;\u00a0<a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2948209-1&amp;h=2936714046&amp;u=https%3A%2F%2Fwww.mirscientific.com%2F&amp;a=miR+Scientific%2C+LLC\" rel=\"nofollow noopener noreferrer\">miR Scientific, LLC<\/a>, a healthcare company whose purpose is to transform global cancer management by providing early and highly accurate detection, characterization and monitoring of disease, announced today that it has received Breakthrough Device Designation&#8230;<\/p>\n","protected":false},"author":1,"featured_media":84631,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[13],"tags":[],"class_list":["post-84630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-salud"],"acf":[],"_links":{"self":[{"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/posts\/84630","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/comments?post=84630"}],"version-history":[{"count":0,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/posts\/84630\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/media\/84631"}],"wp:attachment":[{"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/media?parent=84630"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/categories?post=84630"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hispanicprwire.com\/en\/wp-json\/wp\/v2\/tags?post=84630"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}