{"id":791456,"date":"2024-12-02T08:03:19","date_gmt":"2024-12-02T13:03:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology\/"},"modified":"2024-12-02T08:03:19","modified_gmt":"2024-12-02T13:03:19","slug":"clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology\/","title":{"rendered":"Clinical Validation Study on Natera\u2019s Fetal RhD NIPT Published in Obstetrics &amp; Gynecology"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }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 class=\"bwalignc\"><b>Clinical Validation Study on Natera\u2019s Fetal RhD NIPT <\/b><b>Published in <i>Obstetrics &amp; Gynecology<\/i><\/b><\/p>\n<p class=\"bwalignc\"><i>Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3%<\/i><\/p>\n<p>AUSTIN, Texas&#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.natera.com%2F&amp;esheet=54159522&amp;newsitemid=20241202602532&amp;lan=en-US&amp;anchor=Natera%2C+Inc.&amp;index=1&amp;md5=6047985f82cc3e83d1744b37218ceaea\">Natera, Inc.<\/a> (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that <i>Obstetrics &amp; Gynecology <\/i>(also known as <i>The Green Journal<\/i>) <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fjournals.lww.com%2Fgreenjournal%2Fpages%2Farticleviewer.aspx%3Fyear%3D9900%26issue%3D00000%26article%3D01185%26type%3DFulltext&amp;esheet=54159522&amp;newsitemid=20241202602532&amp;lan=en-US&amp;anchor=published+the+Company%26%238217%3Bs+clinical+validation+study&amp;index=2&amp;md5=671b0289a479c1f3b2bdd02c5348fa1a\">published the Company\u2019s clinical validation study<\/a> on its cell-free DNA (cfDNA) Fetal RhD noninvasive prenatal test (Fetal RhD NIPT).<\/p>\n<p>\nNatera\u2019s 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\u2019s 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\u2019s 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.<\/p>\n<p>\nKey highlights of the study include:<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n356\/356 fetuses were correctly identified as fetal RhD positive (sensitivity: 100% [95% CI: 98.9-100.0]).<\/p>\n<\/li>\n<li>\nOf the 297 RhD-negative fetuses, 295 were correctly identified as RhD-negative (specificity of 99.3% [95% CI: 97.6-99.8]).<\/p>\n<\/li>\n<li>\nPositive predictive value for the test was 99.4% and negative predictive value was &gt;99.9%.<\/p>\n<\/li>\n<li>\nThe study included a representative mix of race and ethnicities in the RhD-negative U.S. population.<\/p>\n<\/li>\n<\/ul>\n<p>\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 <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.acog.org%2Fclinical%2Fclinical-guidance%2Fpractice-advisory%2Farticles%2F2024%2F03%2Frhod-immune-globulin-shortages&amp;esheet=54159522&amp;newsitemid=20241202602532&amp;lan=en-US&amp;anchor=guidance&amp;index=3&amp;md5=2a0dd926c7ec4a85c18a055b5118c957\">guidance<\/a> from the American College of Obstetricians and Gynecologists (ACOG) supporting cfDNA screening for fetal RhD testing.<\/p>\n<p>\n\u201cThis large clinical validation study demonstrated excellent performance in identification of fetal RhD status,\u201d 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. \u201cAccess to highly accurate fetal RhD testing has the potential to transform the care of RhD-negative pregnant patients.\u201d<\/p>\n<p>\n\u201cSupporting reproductive health has long been part of Natera\u2019s mission, and we are proud to offer this noninvasive, highly accurate cfDNA test to help clinicians prevent potential complications in future pregnancies,\u201d said Sheetal Parmar, MS CGC, Natera\u2019s senior vice president of medical affairs for women\u2019s health.<\/p>\n<p>\nThe RhD test is an offering within Natera\u2019s women\u2019s health suite of products, which also includes Panorama, the No. 1 ordered noninvasive prenatal test in the U.S.<\/p>\n<p><b>About Panorama<\/b><\/p>\n<p>\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.<\/p>\n<p><b>About Natera<\/b><\/p>\n<p>\nNatera\u2122 is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women\u2019s 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\u2019s 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 <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3732835-1%26h%3D4126071259%26u%3Dhttp%253A%252F%252Fwww.natera.com%252F%26a%3Dwww.natera.com&amp;esheet=54159522&amp;newsitemid=20241202602532&amp;lan=en-US&amp;anchor=www.natera.com&amp;index=4&amp;md5=34aeadbf08136411f36b8ffe5145ef7b\">www.natera.com<\/a>.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20241202602532r1&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\/20241202602532\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20241202602532\/en\/<\/a><\/span><\/p>\n<p>\nInvestor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, <a rel=\"nofollow\" href=\"mailto:investor@natera.com\">investor@natera.com<br \/>\n<\/a><br \/>Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., <a rel=\"nofollow\" href=\"mailto:pr@natera.com\">pr@natera.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> United States North America California Texas<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Health Genetics General Health Clinical Trials Research Science Biotechnology<\/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\/20241202602532\/en\/1736351\/3\/Natera_floret_Logo_%281%29.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>Clinical Validation Study on Natera\u2019s Fetal RhD NIPT Published in Obstetrics &amp; Gynecology 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&#8211;(BUSINESS WIRE)&#8211;Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that Obstetrics &amp; Gynecology (also known as The Green Journal) published the Company\u2019s clinical validation study on its cell-free DNA (cfDNA) Fetal RhD noninvasive prenatal test (Fetal RhD NIPT). Natera\u2019s 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 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Clinical Validation Study on Natera\u2019s Fetal RhD NIPT Published in Obstetrics &amp; Gynecology&#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-791456","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>Clinical Validation Study on Natera\u2019s Fetal RhD NIPT Published in Obstetrics &amp; Gynecology - 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\/clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Validation Study on Natera\u2019s Fetal RhD NIPT Published in Obstetrics &amp; Gynecology - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Clinical Validation Study on Natera\u2019s Fetal RhD NIPT Published in Obstetrics &amp; Gynecology 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&#8211;(BUSINESS WIRE)&#8211;Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that Obstetrics &amp; Gynecology (also known as The Green Journal) published the Company\u2019s clinical validation study on its cell-free DNA (cfDNA) Fetal RhD noninvasive prenatal test (Fetal RhD NIPT). Natera\u2019s 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. 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(NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that Obstetrics &amp; Gynecology (also known as The Green Journal) published the Company\u2019s clinical validation study on its cell-free DNA (cfDNA) Fetal RhD noninvasive prenatal test (Fetal RhD NIPT). Natera\u2019s 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 &hellip; Continue reading \"Clinical Validation Study on Natera\u2019s Fetal RhD NIPT Published in Obstetrics &amp; Gynecology\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology\/","og_site_name":"Market Newsdesk","article_published_time":"2024-12-02T13:03:19+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20241202602532r1&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":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Clinical Validation Study on Natera\u2019s Fetal RhD NIPT Published in Obstetrics &amp; 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