{"id":965185,"date":"2026-05-20T08:14:51","date_gmt":"2026-05-20T12:14:51","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-new-guardant360-liquid-cdx-the-largest-fda-approved-liquid-biopsy-panel-with-a-100x-expanded-footprint\/"},"modified":"2026-05-20T08:14:51","modified_gmt":"2026-05-20T12:14:51","slug":"fda-approves-new-guardant360-liquid-cdx-the-largest-fda-approved-liquid-biopsy-panel-with-a-100x-expanded-footprint","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-new-guardant360-liquid-cdx-the-largest-fda-approved-liquid-biopsy-panel-with-a-100x-expanded-footprint\/","title":{"rendered":"FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint"},"content":{"rendered":"<p>        <!--.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><b>FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li><i>Guardant Health\u2019s new FDA-approved liquid biopsy integrates genomic and epigenomic insights to provide a more complete, actionable view of cancer from a simple blood draw<\/i><\/li>\n<li><i>Approval strengthens Guardant\u2019s leadership in comprehensive molecular profiling and advances a unified testing experience across liquid and tissue<\/i><\/li>\n<\/ul>\n<p>PALO ALTO, Calif.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360\u00ae Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. Guardant360 Liquid CDx is the largest FDA-approved liquid biopsy panel, assessing a 100X wider genomic footprint than the previously approved Guardant360 CDx to deliver comprehensive tumor profiling results. The seven previously U.S. FDA-approved companion diagnostic indications for Guardant360 CDx transfer to the new test with the FDA approval of Guardant360 Liquid CDx.<\/p>\n<p>\nGuardant360 Liquid CDx is powered by Guardant\u2019s Smart Platform, which unlocks new dimensions of tumor biology by integrating genomic and epigenomic profiling from a single blood draw, providing a several-fold increase in sensitivity for circulating tumor DNA (ctDNA) detection from the previous Guardant360 CDx test and revealing clinically actionable insights that genomics alone may miss.<\/p>\n<p>\n\u201cPrecision oncology is only as strong as the information clinicians have at the moment they need to make a decision,\u201d said Helmy Eltoukhy, Guardant Health chairman and co-CEO. \u201cWith FDA approval of the new Guardant360 Liquid CDx, cancer care enters a new era: one where genomics, epigenomics, advanced AI, and learnings from more than one million patients tested converge to deliver a more complete, actionable view of cancer from just a blood draw. This approval moves us closer to a future where every physician has the right information at the right time to make the right decision.\u201d<\/p>\n<p>\nGuardant360 Liquid CDx builds on Guardant\u2019s leadership pioneering the first FDA-approved comprehensive liquid biopsy. Building on this track record, the test also is the first liquid biopsy to simultaneously define both the genotype and key phenotype information<sup>1<\/sup>, taking precision oncology to the next level. The updated test delivers fast results in as little as seven days, providing the information needed for clinical decisions regardless of tissue availability, line of therapy, or practice setting.<\/p>\n<p>\nGuardant\u2019s full product portfolio is now upgraded to its proprietary Smart Platform, an AI-enabled multiomic technology platform behind its next generation of cancer tests, supporting new clinical applications across the cancer care continuum from a single, scalable testing foundation.<\/p>\n<p><b>About Guardant Health<\/b><\/p>\n<p>\nGuardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fguardanthealth.com%2F&amp;esheet=54539031&amp;newsitemid=20260520531436&amp;lan=en-US&amp;anchor=guardanthealth.com&amp;index=1&amp;md5=eff3decf107ed66aff715e366e728c55\">guardanthealth.com<\/a> and follow the company on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fguardanthealth&amp;esheet=54539031&amp;newsitemid=20260520531436&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=2&amp;md5=4e879c4a7d7004e6d4fe45989b2466b0\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FGuardantHealth&amp;esheet=54539031&amp;newsitemid=20260520531436&amp;lan=en-US&amp;anchor=X+%28Twitter%29&amp;index=3&amp;md5=969be8bf210cd170f92d32f6e02b1d57\">X (Twitter)<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.facebook.com%2Fguardanthealth&amp;esheet=54539031&amp;newsitemid=20260520531436&amp;lan=en-US&amp;anchor=Facebook&amp;index=4&amp;md5=bb06a8696fdb3c615b390f4c849aa0bf\">Facebook<\/a>.<\/p>\n<p><b>About Guardant360\u00ae Liquid CDx<\/b><\/p>\n<p>\nThe largest FDA-approved liquid biopsy, Guardant360 Liquid CDx is the only FDA-approved liquid biopsy test integrating genomic and epigenomic data for comprehensive insights. Guardant360 Liquid CDx is approved as a companion diagnostic for multiple therapies in non-small cell lung cancer and colorectal cancer. It is also the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with <i>ESR1 <\/i>mutations. The test is broadly covered by Medicare and commercial insurers, representing over 300 million lives.<\/p>\n<p><b>Guardant Health Forward-Looking Statements<\/b><\/p>\n<p>\nThis press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health\u2019s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health\u2019s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions \u201cRisk Factors\u201d and \u201cManagement\u2019s Discussion and Analysis of Financial Condition and Results of Operation\u201d and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health\u2019s views as of any date subsequent to the date of this press release.<\/p>\n<p><sup>1<\/sup> Offered by professional service only. The professional service report is not reviewed nor approved by the FDA.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260520531436r1&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\/20260520531436\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260520531436\/en\/<\/a><\/span><\/p>\n<p><b>Investor Contact:<br \/>\n<\/b><br \/>Zarak Khurshid<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:investors@guardanthealth.com\">investors@guardanthealth.com<\/a><\/p>\n<p><b>Media Contact:<br \/>\n<\/b><br \/>Meaghan Smith<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:press@guardanthealth.com\">press@guardanthealth.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> California United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Oncology Medical Devices FDA Health Genetics Health Technology<\/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\/20260520531436\/en\/2768869\/3\/GuardantHealthMasterLogo_ND_RGB%403x.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>FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint Guardant Health\u2019s new FDA-approved liquid biopsy integrates genomic and epigenomic insights to provide a more complete, actionable view of cancer from a simple blood draw Approval strengthens Guardant\u2019s leadership in comprehensive molecular profiling and advances a unified testing experience across liquid and tissue PALO ALTO, Calif.&#8211;(BUSINESS WIRE)&#8211; Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360\u00ae Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. Guardant360 Liquid CDx is the largest FDA-approved &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-new-guardant360-liquid-cdx-the-largest-fda-approved-liquid-biopsy-panel-with-a-100x-expanded-footprint\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint&#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-965185","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint - 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\/fda-approves-new-guardant360-liquid-cdx-the-largest-fda-approved-liquid-biopsy-panel-with-a-100x-expanded-footprint\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint Guardant Health\u2019s new FDA-approved liquid biopsy integrates genomic and epigenomic insights to provide a more complete, actionable view of cancer from a simple blood draw Approval strengthens Guardant\u2019s leadership in comprehensive molecular profiling and advances a unified testing experience across liquid and tissue PALO ALTO, Calif.&#8211;(BUSINESS WIRE)&#8211; Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360\u00ae Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. 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(Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360\u00ae Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. 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