{"id":404931,"date":"2020-12-22T22:03:06","date_gmt":"2020-12-23T03:03:06","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=404931"},"modified":"2020-12-22T22:03:06","modified_gmt":"2020-12-23T03:03:06","slug":"agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/","title":{"rendered":"Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan"},"content":{"rendered":"<p>        <!--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><b>Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan<\/b><\/p>\n<p>SANTA CLARA, Calif.&#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.agilent.com&amp;esheet=52352829&amp;newsitemid=20201222005553&amp;lan=en-US&amp;anchor=Agilent+Technologies+Inc.&amp;index=1&amp;md5=064bb01adb3a2b3afae24faff372b673\">Agilent Technologies Inc.<\/a> (NYSE: A) announced it has obtained clearance from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.agilent.com%2Fen%2Fpromotions%2Fgenetisuredx-postnatal-assay&amp;esheet=52352829&amp;newsitemid=20201222005553&amp;lan=en-US&amp;anchor=GenetiSure+Dx+Postnatal+Assay&amp;index=2&amp;md5=3a607b96c9f8dfc8335d50c70867c347\">GenetiSure Dx Postnatal Assay<\/a> \u2013 a microarray-based assay for diagnostic use. This assay enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital anomalies, and unexplained dysmorphic features. The company also announced that it has registered its microarray scanner, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.agilent.com%2Fen%2Fproduct%2Fgene-expression-microarray-platform%2Fgene-expression-microarray-scanners-equipment%2Fsurescan-dx-microarray-scanner-228492&amp;esheet=52352829&amp;newsitemid=20201222005553&amp;lan=en-US&amp;anchor=SureScan+Dx+Scanner&amp;index=3&amp;md5=7dbd69ac012685adbf45f92743b80110\">SureScan Dx Scanner<\/a>, as a Class I medical device in Japan, intended for use with the assay.\n<\/p>\n<p>\nBased on Agilent&#8217;s proprietary microarray for comparative genomic hybridization (CGH), the GenetiSure Dx Postnatal Assay is a qualitative assay for the postnatal diagnosis of copy-number alterations (CNVs) and copy-neutral loss of heterozygosity (cnLOH) from genomic DNA (gDNA), obtained from the peripheral whole blood in patients who have been referred for chromosomal testing based on clinical presentation. The GenetiSure Dx Postnatal Assay is the result of a clinical validation utilizing 900 samples and brings CGH technology into a diagnostic setting in Japan. Available since 2017 as an <i>in vitro<\/i> diagnostic assay (IVD) in Europe and the United States, Japanese clinical geneticists can now have access to this assay to help identify a definitive genetic diagnosis for their patients.\n<\/p>\n<p>\n&#8220;We are truly excited and humbled to bring the power of diagnostic microarray testing to the Japanese market. With clinically-proven performance and a track record of adoption in the U.S. and European Union, this presents a compelling option to patients, their families, and medical professionals to minimize the diagnostic odyssey often faced in clinical genetic testing settings,\u201d said Kevin Meldrum, general manager and vice president of Agilent\u2019s Genomics Solutions Division. \u201cAgilent is in the process of preparing for the commercial launch of the assay in Japan, expected to occur in the first half of 2021.\u201d\n<\/p>\n<p>\nThe assay is intended to be used on the SureScan Dx Microarray Scanner System and analyzed by CytoDx Software. This device is not intended to be used for standalone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations.\n<\/p>\n<p><b>About Agilent Technologies<\/b><\/p>\n<p>\nAgilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets, delivering insight and innovation toward improving the quality of life. Agilent instruments, software, services, solutions, and people provide trusted answers to customers&#8217; most challenging questions. The company generated revenue of $5.34 billion in fiscal 2020 and employs 16,400 people worldwide. Information about Agilent is available at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.agilent.com&amp;esheet=52352829&amp;newsitemid=20201222005553&amp;lan=en-US&amp;anchor=www.agilent.com&amp;index=4&amp;md5=e877121055103b372fb1df77f571a9cb\">www.agilent.com<\/a>. To receive the latest Agilent news, subscribe to the Agilent <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.agilent.com%2Fabout%2Fnewsroom%2Fsubscribe%2F&amp;esheet=52352829&amp;newsitemid=20201222005553&amp;lan=en-US&amp;anchor=Newsroom&amp;index=5&amp;md5=4b07fd92dd6cedc14a2f547b64e71b07\">Newsroom<\/a>. Follow Agilent on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2F1526%2F&amp;esheet=52352829&amp;newsitemid=20201222005553&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=6&amp;md5=3dc52f8b6f781ca322cfeacef44cf52b\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FAgilent&amp;esheet=52352829&amp;newsitemid=20201222005553&amp;lan=en-US&amp;anchor=Twitter&amp;index=7&amp;md5=5fcb1738f8a25209f73e332c3bbaa970\">Twitter<\/a>, and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FAgilent.Tech&amp;esheet=52352829&amp;newsitemid=20201222005553&amp;lan=en-US&amp;anchor=Facebook&amp;index=8&amp;md5=be1d2fbf477c8f4ab389c25e2b99abeb\">Facebook<\/a>.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201222005553r1&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\/20201222005553\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20201222005553\/en\/<\/a><\/span><\/p>\n<p>\nNaomi Goumillout<br \/>\n<br \/>Agilent Technologies<br \/>\n<br \/>+1.781.266.2819<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:naomi.goumillout@agilent.com\">naomi.goumillout@agilent.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> United States Japan North America Asia Pacific California<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Genetics Health Medical Devices<\/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\/20201222005553\/en\/33292\/3\/Agilent300_200w.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>Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan SANTA CLARA, Calif.&#8211;(BUSINESS WIRE)&#8211;Agilent Technologies Inc. (NYSE: A) announced it has obtained clearance from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the GenetiSure Dx Postnatal Assay \u2013 a microarray-based assay for diagnostic use. This assay enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital anomalies, and unexplained dysmorphic features. The company also announced that it has registered its microarray scanner, SureScan Dx Scanner, as a Class I medical device in Japan, intended for use with the assay. Based on Agilent&#8217;s proprietary microarray for comparative genomic hybridization (CGH), the GenetiSure Dx Postnatal Assay is a qualitative assay for the postnatal diagnosis of &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan&#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-404931","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>Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan - 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\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan SANTA CLARA, Calif.&#8211;(BUSINESS WIRE)&#8211;Agilent Technologies Inc. (NYSE: A) announced it has obtained clearance from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the GenetiSure Dx Postnatal Assay \u2013 a microarray-based assay for diagnostic use. This assay enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital anomalies, and unexplained dysmorphic features. The company also announced that it has registered its microarray scanner, SureScan Dx Scanner, as a Class I medical device in Japan, intended for use with the assay. Based on Agilent&#8217;s proprietary microarray for comparative genomic hybridization (CGH), the GenetiSure Dx Postnatal Assay is a qualitative assay for the postnatal diagnosis of &hellip; Continue reading &quot;Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-23T03:03:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201222005553r1&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\\\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan\",\"datePublished\":\"2020-12-23T03:03:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\\\/\"},\"wordCount\":493,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20201222005553r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\\\/\",\"name\":\"Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan - 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(NYSE: A) announced it has obtained clearance from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the GenetiSure Dx Postnatal Assay \u2013 a microarray-based assay for diagnostic use. This assay enables clinical geneticists to detect genetic aberrations associated with developmental delay, intellectual disabilities, congenital anomalies, and unexplained dysmorphic features. The company also announced that it has registered its microarray scanner, SureScan Dx Scanner, as a Class I medical device in Japan, intended for use with the assay. Based on Agilent&#8217;s proprietary microarray for comparative genomic hybridization (CGH), the GenetiSure Dx Postnatal Assay is a qualitative assay for the postnatal diagnosis of &hellip; Continue reading \"Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/","og_site_name":"Market Newsdesk","article_published_time":"2020-12-23T03:03:06+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201222005553r1&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\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan","datePublished":"2020-12-23T03:03:06+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/"},"wordCount":493,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201222005553r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-approval-for-genetisure-dx-postnatal-assay-in-japan\/","name":"Agilent Receives Approval for GenetiSure Dx Postnatal Assay in Japan - 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