{"id":468035,"date":"2025-10-02T08:50:16","date_gmt":"2025-10-02T08:50:16","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/468035\/"},"modified":"2025-10-02T08:50:16","modified_gmt":"2025-10-02T08:50:16","slug":"enrollment-tops-1600-in-nateras-expand-trial-of-single-gene-nipt","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/468035\/","title":{"rendered":"Enrollment Tops 1,600 in Natera\u2019s EXPAND Trial of Single Gene NIPT"},"content":{"rendered":"<p class=\"bwalignc\">\nEXPAND is a prospective, blinded, multi-site clinical trial with diagnostic outcomes on all subjects<\/p>\n<p>AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211;Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing and precision medicine, today announced a milestone in the EXPAND trial with the enrollment of over 1,600 patients.<\/p>\n<p><a class=\"Link\" href=\"https:\/\/mms.businesswire.com\/media\/20251001833625\/en\/1736351\/4\/Natera_floret_Logo.jpg\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251001833625\/en\/1736351\/22\/Natera_floret_Logo.jpg\"\/><\/a><br \/><a class=\"Link\" href=\"https:\/\/mms.businesswire.com\/media\/20251001833625\/en\/1736351\/4\/Natera_floret_Logo.jpg\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251001833625\/en\/1736351\/21\/Natera_floret_Logo.jpg\"\/><\/a><\/p>\n<p>\nInitiated in 2023, EXPAND is designed to be the defining prospective clinical trial in the category, supporting Natera\u2019s Fetal Focus\u2122 single gene noninvasive prenatal test (NIPT) for inherited conditions. The study is differentiated by having all outcomes, including both positive and negative results, confirmed by genetic truth using prenatal or postnatal diagnostic testing1, 2. EXPAND has enrolled a diverse, multi-ethnic population from leading academic medical centers and maternal fetal medicine clinics.<\/p>\n<p>\nNatera expects to report a large-scale analysis from the trial in the fourth quarter of 2025. This follows the successful initial readout of EXPAND earlier this year, in which Fetal Focus demonstrated 91% sensitivity and successfully identified 5\/5 fetuses affected by challenging homozygous variants.<\/p>\n<p>\nFetal Focus addresses a clear unmet need when the biological father is unavailable or unable to complete carrier testing. While testing both partners remains the guideline-recommended gold standard3,4 and the optimal approach to screen for affected pregnancies, if carrier testing of the biological father is not possible, Fetal Focus is a clinically useful alternative.<\/p>\n<p>\n\u201cFetal Focus is addressing an important clinical need for patients and has shown excellent performance in the initial readout of the EXPAND trial,\u201d said Sheetal Parmar, senior vice president of medical affairs, women\u2019s health at Natera. \u201cOur proprietary LinkedSNP\u2122 technology improves detection of inherited conditions, giving families and clinicians additional insights during pregnancy.\u201d<\/p>\n<p>\n<b>References<\/b><\/p>\n<ol class=\"bwlistdecimal\">\n<li>\nInternal data on file. In EXPAND, the study participants and investigators are blinded to the Fetal Focus\u2122 test results.<\/li>\n<li>\nEXpanding Prenatal Cell Free DNA Screening Across MoNogenic Disorders (EXPAND). <a class=\"Link\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06808880&amp;esheet=54332276&amp;newsitemid=20251001833625&amp;lan=en-US&amp;anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06808880&amp;index=1&amp;md5=0b94b80b6cc65f3b6415a1cd664da982\" target=\"_blank\" rel=\"noopener\">https:\/\/clinicaltrials.gov\/study\/NCT06808880<\/a>. Accessed July 2025.<\/li>\n<li>\nGregg et al., Genetics in Medicine volume 23, pages 1793\u20131806 (2021).<\/li>\n<li>\nACOG Practice Committee Opinion, 691 (2017; reaffirmed in 2025).<\/li>\n<\/ol>\n<p>\n<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 supported by more than 300 peer-reviewed publications that demonstrate excellent performance. 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 class=\"Link\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.natera.com&amp;esheet=54332276&amp;newsitemid=20251001833625&amp;lan=en-US&amp;anchor=www.natera.com&amp;index=2&amp;md5=99edde3608da5b7010b6df02f5bee953\" target=\"_blank\" rel=\"noopener\">www.natera.com<\/a>.<\/p>\n<p>\n<b>Forward-Looking Statements<\/b><\/p>\n<p>\nAll statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera\u2019s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera\u2019s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in \u201cRisk Factors\u201d in Natera\u2019s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at <a class=\"Link\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Finvestor.natera.com%2Foverview%2Fdefault.aspx&amp;esheet=54332276&amp;newsitemid=20251001833625&amp;lan=en-US&amp;anchor=www.natera.com%2Finvestors&amp;index=3&amp;md5=4bc8744b1213682d9fd011d6f1a53544\" target=\"_blank\" rel=\"noopener\">www.natera.com\/investors<\/a> and <a class=\"Link\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sec.gov&amp;esheet=54332276&amp;newsitemid=20251001833625&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=4&amp;md5=c63446066f746280e6fa2f2ac972f004\" target=\"_blank\" rel=\"noopener\">www.sec.gov<\/a>.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nInvestor Relations: Mike Brophy, CFO, Natera, Inc., <a class=\"Link\" href=\"https:\/\/www.biospace.com\/press-releases\/mailto:investor@natera.com\" target=\"_blank\" rel=\"noopener\">investor@natera.com<\/a><br \/>Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., <a class=\"Link\" href=\"https:\/\/www.biospace.com\/press-releases\/mailto:pr@natera.com\" target=\"_blank\" rel=\"noopener\">pr@natera.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"EXPAND is a prospective, blinded, multi-site clinical trial with diagnostic outcomes on all subjects AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211;Natera, Inc.&hellip;\n","protected":false},"author":2,"featured_media":468036,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3846],"tags":[267,70,16,15],"class_list":{"0":"post-468035","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-genetics","8":"tag-genetics","9":"tag-science","10":"tag-uk","11":"tag-united-kingdom"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/115303719192594267","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/468035","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=468035"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/468035\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/468036"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=468035"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=468035"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=468035"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}