{"id":929037,"date":"2026-01-21T06:03:02","date_gmt":"2026-01-21T11:03:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/natera-publishes-clinical-validation-of-latitude-tissue-free-mrd-test-in-colorectal-cancer\/"},"modified":"2026-01-21T06:03:02","modified_gmt":"2026-01-21T11:03:02","slug":"natera-publishes-clinical-validation-of-latitude-tissue-free-mrd-test-in-colorectal-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/natera-publishes-clinical-validation-of-latitude-tissue-free-mrd-test-in-colorectal-cancer\/","title":{"rendered":"Natera Publishes Clinical Validation of Latitude\u2122 Tissue-Free MRD Test in Colorectal Cancer"},"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>Natera Publishes Clinical Validation of Latitude\u2122 Tissue-Free MRD Test in Colorectal Cancer<\/b><\/p>\n<p class=\"bwalignc\"><i>Study reports high sensitivity and specificity, enabling MolDX submission and path to reimbursement in CRC<\/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&amp;esheet=54400911&amp;newsitemid=20260121444465&amp;lan=en-US&amp;anchor=Natera%2C+Inc.&amp;index=1&amp;md5=74f2d173318f51f72872ae32fd3e5d38\">Natera, Inc.<\/a> (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.nature.com%2Farticles%2Fs41698-026-01277-5&amp;esheet=54400911&amp;newsitemid=20260121444465&amp;lan=en-US&amp;anchor=the+publication&amp;index=2&amp;md5=bc3760ba40ce4ac76e540d74e509f6d6\">the publication<\/a> in <i>npj Precision Oncology <\/i>of the validation study for its Latitude tissue-free molecular residual disease assay (tfMRD) in colorectal cancer (CRC). The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI).<\/p>\n<p>\nThe study analyzed 1,230 timepoints from 195 CRC patients who participated in the GALAXY clinical trial, one of the largest and most comprehensive tfMRD studies in resectable CRC. The scale and rigor of this dataset, combined with excellent clinical performance, provides support for submission to the Centers for Medicare &amp; Medicaid Services\u2019 (CMS) Molecular Diagnostics Services Program (MolDX). Key findings from the publication include:<\/p>\n<ul class=\"bwlistdisc\">\n<li><b>High sensitivity: <\/b>longitudinal sensitivity of 84.4%, with median lead time of 4.6 months ahead of radiographic recurrence.\n<\/li>\n<li><b>High specificity:<\/b> 97.2% sample-level specificity and 92.1% patient-level specificity, providing strong actionability when an MRD-positive is observed.\n<\/li>\n<li><b>Robust prognostic value:<\/b> MRD-positivity was associated with worse outcomes in both the MRD (HR: 10, p&lt;0.001) and surveillance settings (HR: 31.9, p&lt;0.001).\n<\/li>\n<li><b>Clear predictive value for adjuvant chemotherapy (ACT) benefit:<\/b> In high-risk stage II and stage III patients, those who were MRD-positive following surgery experienced a significant benefit from ACT (adj.HR=0.014, <i>P<\/i>&lt;0.0001), compared to MRD-negative patients, who observed no meaningful treatment benefit.\n<\/li>\n<\/ul>\n<p>\nLatitude is a methylation-based test that detects circulating tumor DNA (ctDNA) without the need for tumor tissue. The assay complements Natera\u2019s tumor-informed and personalized Signatera\u2122 test, providing physicians and patients with a highly-sensitive testing option when tissue is unavailable. Natera is currently developing and validating Latitude for several additional cancer indications, expected to launch in 2026.<\/p>\n<p>\n\u201cThe data from our latest publication underscores Natera\u2019s commitment to providing solutions for patients diagnosed with colorectal cancer,\u201d said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. \u201cLatitude delivers high-performance MRD detection for clinical situations where tumor-informed testing with Signatera is not possible or practical. Since launching in 2025, Latitude has experienced strong interest among clinicians, and we look forward to offering the test in additional histologies.\u201d<\/p>\n<p><b>About Natera<\/b><\/p>\n<p>\nNatera\u2122 is a global leader in cell-free DNA and precision medicine, 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 350 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, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.natera.com&amp;esheet=54400911&amp;newsitemid=20260121444465&amp;lan=en-US&amp;anchor=www.natera.com&amp;index=3&amp;md5=52484d55e7e85624fd3e8ab7a325f3e9\">www.natera.com<\/a>.<\/p>\n<p><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 our efforts to develop and commercialize new product offerings, 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 &#8220;Risk Factors&#8221; 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 rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Finvestor.natera.com%2Fnews%2Fdefault.aspx&amp;esheet=54400911&amp;newsitemid=20260121444465&amp;lan=en-US&amp;anchor=www.natera.com%2Finvestors&amp;index=4&amp;md5=37f251cef034a41aafc858fb47f45938\">www.natera.com\/investors<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sec.gov%2F&amp;esheet=54400911&amp;newsitemid=20260121444465&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=5&amp;md5=37f4ff5e085167924906f5bfa5374601\">www.sec.gov<\/a>.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260121444465r1&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\/20260121444465\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260121444465\/en\/<\/a><\/span><\/p>\n<p>\nInvestor Relations: Mike Brophy, CFO, Natera, Inc., <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> Texas United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Oncology Health Hospitals Genetics General Health Clinical Trials 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\/20260121444465\/en\/1736351\/3\/Natera_floret_Logo.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>Natera Publishes Clinical Validation of Latitude\u2122 Tissue-Free MRD Test in Colorectal Cancer Study reports high sensitivity and specificity, enabling MolDX submission and path to reimbursement in CRC AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211;Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication in npj Precision Oncology of the validation study for its Latitude tissue-free molecular residual disease assay (tfMRD) in colorectal cancer (CRC). The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI). The study analyzed 1,230 timepoints from 195 CRC patients who participated in the GALAXY clinical trial, one of the largest and most comprehensive tfMRD studies in resectable CRC. The scale and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/natera-publishes-clinical-validation-of-latitude-tissue-free-mrd-test-in-colorectal-cancer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Natera Publishes Clinical Validation of Latitude\u2122 Tissue-Free MRD Test in Colorectal Cancer&#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-929037","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Natera Publishes Clinical Validation of Latitude\u2122 Tissue-Free MRD Test in Colorectal Cancer - 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\/natera-publishes-clinical-validation-of-latitude-tissue-free-mrd-test-in-colorectal-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Natera Publishes Clinical Validation of Latitude\u2122 Tissue-Free MRD Test in Colorectal Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Natera Publishes Clinical Validation of Latitude\u2122 Tissue-Free MRD Test in Colorectal Cancer Study reports high sensitivity and specificity, enabling MolDX submission and path to reimbursement in CRC AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211;Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication in npj Precision Oncology of the validation study for its Latitude tissue-free molecular residual disease assay (tfMRD) in colorectal cancer (CRC). The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI). The study analyzed 1,230 timepoints from 195 CRC patients who participated in the GALAXY clinical trial, one of the largest and most comprehensive tfMRD studies in resectable CRC. 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(NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication in npj Precision Oncology of the validation study for its Latitude tissue-free molecular residual disease assay (tfMRD) in colorectal cancer (CRC). The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI). The study analyzed 1,230 timepoints from 195 CRC patients who participated in the GALAXY clinical trial, one of the largest and most comprehensive tfMRD studies in resectable CRC. 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