Clinical Validation Study on Natera’s Fetal RhD NIPT Published in Obstetrics & Gynecology

Business Wire12-02

Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3% AUSTIN, Texas, December 02, 2024--(BUSINESS WIRE)--Natera, Inc. (...

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(...</p>\n\n<a href=\"https://finance.yahoo.com/news/clinical-validation-study-natera-fetal-130000024.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Clinical Validation Study on Natera’s Fetal RhD NIPT Published in Obstetrics & Gynecology</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nClinical Validation Study on Natera’s Fetal RhD NIPT Published in Obstetrics & Gynecology\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-12-02 21:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/clinical-validation-study-natera-fetal-130000024.html><strong>Business Wire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3%\nAUSTIN, Texas, December 02, 2024--(BUSINESS WIRE)--Natera, Inc. (...</p>\n\n<a href=\"https://finance.yahoo.com/news/clinical-validation-study-natera-fetal-130000024.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00B29SXL02.USD","symbol_name":"FIRST SENTIER GLOBAL LISTED INFRASTRUCTURE \"I\" (USD) INC","start_time":0,"source_url":"https://finance.yahoo.com/news/clinical-validation-study-natera-fetal-130000024.html","article_id":"2488952328","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/0E_FQCipUw5oIeubRQfXlQ--~B/aD0yMDA7dz0yMDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/2ada5b170b1596621eff6cf9fa39ca68"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2488952328","pubTimestamp":1733144400,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3%. AUSTIN, Texas, December 02, 2024----Natera, Inc. , a global leader in cell-free DNA and genetic testing, today announced that Obstetrics & Gynecology  published the Company’s clinical validation study on its cell-free DNA  Fetal RhD noninvasive prenatal test .Natera’s study is the largest clinical validation of a fetal RhD test performed in the United States to date, with fetal RhD status confirmed via newborn serology in 655 RhD-negative pregnant patients. The study provides compelling scientific evidence on the ability of Natera’s Fetal RhD NIPT to identify fetal RhD status, and demonstrates its potential to assist patients and clinicians in the prevention and management of RhD alloimmunization. In addition, Natera’s next generation sequencing -based Fetal RhD test can identify RHD pseudogene and other hybrid variants that are more commonly occurring in","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00B29SXL02.USD":"FIRST SENTIER GLOBAL LISTED INFRASTRUCTURE \"I\" (USD) INC","IE00BMG7P694.USD":"Legg Mason ClearBridge - Global Infrastructure Income A Mdis USD Plus","LU2065731478.USD":"ALLSPRING (LUX) WORLDWIDE FUND - SMALL CAP INNOVA \"I\" (USD) ACC","IE00B29SXK94.USD":"FIRST SENTIER GLOBAL LISTED INFRASTRUCTURE \"I\" (USD) ACC","IE00BZ18W340.USD":"BNY MELLON GLOBAL INFRASTRUCTURE INCOME \"B\" (USD) ACC","IE00BD4GTT62.SGD":"Legg Mason ClearBridge Infrastructure Value A SGD-H (mdis) plus","D":"道明尼资源","BK4585":"ETF&股票定投概念","BK4139":"生物科技","NGS":"Natural Gas Services Group Inc","LU2065171311.SGD":"M&G (LUX) GLOBAL MAXIMA \"A\" (SGD) ACC","IE00BZ18W456.USD":"BNY MELLON GLOBAL INFRASTRUCTURE INCOME \"B\" (USD) INC","LU2065171402.SGD":"M&G (LUX) GLOBAL MAXIMA \"A\" (SGD) INC","BK4566":"资本集团","IE00BD4GTW91.USD":"LEGG MASON CLEARBRIDGEINFRASTRUCTURE VALUE \"A\" (USDHDG) INC","NTRA":"Natera, Inc.","WRD":"文远知行","BK4588":"碎股","IE00BMG7P702.HKD":"FTGF CLEARBRIDGE GLOBAL INFRASTRUCTURE INCOME \"A\" (HKD) INC","BK4208":"复合型公用事业","LU2065170008.USD":"M&G (LUX) GLOBAL MAXIMA \"A\" (USD) INC","IE00BMG7P587.USD":"LEGG MASON CLEARBRIDGE GLOBAL INFRASTRUCTURE INCOM \"A\" (USD) INC","BK4179":"石油天然气设备与服务","LU0053671581.USD":"摩根大通美国小盘成长股 A(dist)","IE00BD4GTV84.USD":"LEGG MASON CLEARBRIDGEINFRASTRUCTURE VALUE \"A\" (USDHDG) ACC","IE00B3T34201.USD":"BNY MELLON GLOBAL EQUITY INCOME \"B\" (USD) INC","IE00BMQBXF63.USD":"BNY MELLON GLOBAL INFRASTRUCTURE INCOME \"B\" (USD) INC A","IE00BMG7P819.SGD":"Legg Mason ClearBridge - Global Infrastructure Income A Mdis SGD-H Plus","LU2065169927.USD":"M&G (LUX) GLOBAL MAXIMA \"A\" (USD) ACC","IE00BMG7P926.USD":"Legg Mason ClearBridge - Global Infrastructure Income A Acc USD","CLIA":"VERIDIEN CLIMATE ACTION ETF","ACOG":"ALPHA COGNITION INC"},"translate_title":"Natera胎儿RhD NIPT发表在《妇产科》上的临床验证研究","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"WRD":1,"NTRA":1,"NGS":1,"ACOG":1,"CLIA":1,"D":1},"content_text":"Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3%\nAUSTIN, Texas, December 02, 2024--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that Obstetrics & Gynecology (also known as The Green Journal) published the Company’s clinical validation study on its cell-free DNA (cfDNA) Fetal RhD noninvasive prenatal test (Fetal RhD NIPT).\nNatera’s study is the largest clinical validation of a fetal RhD test performed in the United States to date, with fetal RhD status confirmed via newborn serology in 655 RhD-negative pregnant patients. The study provides compelling scientific evidence on the ability of Natera’s Fetal RhD NIPT to identify fetal RhD status, and demonstrates its potential to assist patients and clinicians in the prevention and management of RhD alloimmunization. In addition, Natera’s next generation sequencing (NGS)-based Fetal RhD test can identify RHD pseudogene and other hybrid variants that are more commonly occurring in people of non-European ancestries.\nKey highlights of the study include:\n\n356/356 fetuses were correctly identified as fetal RhD positive (sensitivity: 100% [95% CI: 98.9-100.0]).\nOf the 297 RhD-negative fetuses, 295 were correctly identified as RhD-negative (specificity of 99.3% [95% CI: 97.6-99.8]).\nPositive predictive value for the test was 99.4% and negative predictive value was >99.9%.\nThe study included a representative mix of race and ethnicities in the RhD-negative U.S. population.\n\nRhD alloimmunization, which can lead to hemolytic disease of the fetus and newborn, can occur when an RhD-negative patient carries an RhD-positive fetus. Historically, this risk is well managed by giving Rho(D) immune globulin therapy (RhIg). However, approximately 40% of patients with an RhD-negative fetus receive this medication unnecessarily. This is particularly important as recent nationwide shortages of RhIg have created an even greater need for testing that allows providers to both prevent alloimmunization and conserve supplies of RhIg, consistent with recent guidance from the American College of Obstetricians and Gynecologists (ACOG) supporting cfDNA screening for fetal RhD testing.\n\"This large clinical validation study demonstrated excellent performance in identification of fetal RhD status,\" said Marisa Gilstrop Thompson, M.D., a board-certified physician in Maternal Fetal Medicine, Obstetrics and Gynecology, and Clinical Genetics with the Delaware Center for Maternal and Fetal Medicine of Christiana Care. \"Access to highly accurate fetal RhD testing has the potential to transform the care of RhD-negative pregnant patients.\"\n\"Supporting reproductive health has long been part of Natera’s mission, and we are proud to offer this noninvasive, highly accurate cfDNA test to help clinicians prevent potential complications in future pregnancies,\" said Sheetal Parmar, MS CGC, Natera’s senior vice president of medical affairs for women’s health.\nThe RhD test is an offering within Natera’s women’s health suite of products, which also includes Panorama, the No. 1 ordered noninvasive prenatal test in the U.S.\nAbout Panorama\nPanorama screens for severe genetic disorders as early as nine weeks into pregnancy. The test uses a unique single-nucleotide polymorphism (SNP)-based technology to analyze fetal (placental) DNA obtained through a maternal blood draw. It is the only commercially available NIPT that differentiates between maternal and fetal DNA to assess the risk of aneuploidies. Panorama has been the subject of more than 40 peer-reviewed publications of over 2 million patients. Panorama has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.\nAbout Natera\nNatera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241202602532/en/\nContacts\nInvestor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2488952328"}