{"id":767720,"date":"2023-07-05T09:12:09","date_gmt":"2023-07-05T13:12:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/guardant-health-announces-reimbursement-approval-of-guardant360-cdx-liquid-biopsy-test-in-japan\/"},"modified":"2023-07-05T09:12:09","modified_gmt":"2023-07-05T13:12:09","slug":"guardant-health-announces-reimbursement-approval-of-guardant360-cdx-liquid-biopsy-test-in-japan","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/guardant-health-announces-reimbursement-approval-of-guardant360-cdx-liquid-biopsy-test-in-japan\/","title":{"rendered":"Guardant Health announces reimbursement approval of Guardant360\u00ae CDx liquid biopsy test in Japan"},"content":{"rendered":"<p>        <!--.bwlistdecimal { list-style-type: decimal }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>Guardant Health announces reimbursement approval of Guardant360<sup>\u00ae<\/sup> CDx liquid biopsy test in Japan<\/b><\/p>\n<p><i>Reimbursement supports expanded access to blood-based comprehensive genomic profiling with Guardant360 CDx for patients with advanced solid tumor cancers and their care teams across Japan<\/i><\/p>\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, announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360<sup>\u00ae<\/sup> CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers. This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022.<\/p>\n<p>\nThere were over one million new cancer cases in Japan in 2020 with lung, stomach, prostate, colon and breast being the most prevalent cancer types.<sup>1<\/sup> The Guardant360 CDx test analyzes circulating tumor DNA (ctDNA) to provide comprehensive genomic profiling, or tumor mutation profiling, for all solid tumor cancers. It is used by healthcare professionals to detect actionable biomarkers in a patient\u2019s blood that may help inform their therapy selection.<\/p>\n<p>\nCurrently, Guardant360 CDx is approved by the MHLW as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda<sup>\u00ae <\/sup>(pembrolizumab) and patients with MSI-High advanced colorectal cancer (CRC) who may benefit from Opdivo<sup>\u00ae<\/sup> (nivolumab). The MHLW also granted regulatory approval of Guardant360 CDx as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer (NSCLC) who may benefit from treatment with LUMAKRAS\u2122 (sotorasib).<\/p>\n<p>\n\u201cThe decision of the MHLW to provide reimbursement for Guardant360 CDx represents a significant milestone for the company as Japan is the first country in the Asia-Pacific region to reimburse the use of our test to support advanced cancer patients,\u201d said Helmy Eltoukhy, co-CEO of Guardant Health. \u201cWe are encouraged by the strong support we have received from oncologists in Japan, and we look forward to furthering these partnerships as we continue our commitment to democratize access to precision oncology and bring blood-based comprehensive genomic profiling to patients and care teams across the region.\u201d<\/p>\n<p>\nThe Guardant360 CDx test has achieved U.S. FDA Approval and is CE-Marked for comprehensive genomic profiling across all solid tumor cancers and has become widely accepted for blood-based CGP worldwide. With more than 350 peer-reviewed publications, the test has been trusted by more than 12,000 oncologists with over 400,000 tests ordered to date.<\/p>\n<p><b>About Guardant Health<\/b><\/p>\n<p>\nGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360<sup>\u00ae,<\/sup> Guardant360<sup>\u00ae<\/sup> CDx, Guardant360 TissueNext\u2122, Guardant360 Response\u2122, and GuardantINFINITY\u2122 tests for advanced-stage cancer patients, and Guardant Reveal\u2122 for early-stage cancer patients. The Guardant Health screening portfolio, including the commercially launched Shield\u2122 test, aims to address the needs of individuals eligible for cancer screening. For more information, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fguardanthealth.com%2F&amp;esheet=53438474&amp;newsitemid=20230705875197&amp;lan=en-US&amp;anchor=guardanthealth.com&amp;index=1&amp;md5=1bb4ab05814baf94ec0222dc7ba5ef2e\">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=53438474&amp;newsitemid=20230705875197&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=2&amp;md5=f0989923c00181dba583c8abb5576960\">LinkedIn<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FGuardantHealth&amp;esheet=53438474&amp;newsitemid=20230705875197&amp;lan=en-US&amp;anchor=Twitter&amp;index=3&amp;md5=571ded3cd373a7e7bb8f39030d45863e\">Twitter<\/a>.<\/p>\n<p><b>Forward-Looking Statement<\/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, 2022, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. 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><b>References:<\/b><\/p>\n<ol class=\"bwlistdecimal\">\n<li>\nInternational Agency for Research on Cancer. Japan. Globocan 2020. Accessed online June 29, 2023. <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fgco.iarc.fr%2Ftoday%2Fdata%2Ffactsheets%2Fpopulations%2F392-japan-fact-sheets.pdf&amp;esheet=53438474&amp;newsitemid=20230705875197&amp;lan=en-US&amp;anchor=https%3A%2F%2Fgco.iarc.fr%2Ftoday%2Fdata%2Ffactsheets%2Fpopulations%2F392-japan-fact-sheets.pdf&amp;index=4&amp;md5=2c50cb7e34c6adf20184c2f2e3ec0b4b\">https:\/\/gco.iarc.fr\/today\/data\/factsheets\/populations\/392-japan-fact-sheets.pdf<\/a><\/li>\n<\/ol>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230705875197r1&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\/20230705875197\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20230705875197\/en\/<\/a><\/span><\/p>\n<p><b>Investor Contact:<br \/>\n<\/b><br \/>Alex Kleban<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:investors@guardanthealth.com\">investors@guardanthealth.com<br \/>\n<\/a><br \/>+1 657-254-5417<\/p>\n<p><b>Media Contact:<br \/>\n<\/b><br \/>Breen Weir<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:press@guardanthealth.com\">press@guardanthealth.com<br \/>\n<\/a><br \/>+1 843-384-0095<\/p>\n<p><b>KEYWORDS:<\/b> California United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology Medical Devices Health Genetics Oncology<\/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\/20230705875197\/en\/1330243\/3\/GuardantHealthLogo_TM_RGB-2C.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>Guardant Health announces reimbursement approval of Guardant360\u00ae CDx liquid biopsy test in Japan Reimbursement supports expanded access to blood-based comprehensive genomic profiling with Guardant360 CDx for patients with advanced solid tumor cancers and their care teams across Japan PALO ALTO, Calif.&#8211;(BUSINESS WIRE)&#8211; Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360\u00ae CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers. This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022. There were over &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/guardant-health-announces-reimbursement-approval-of-guardant360-cdx-liquid-biopsy-test-in-japan\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Guardant Health announces reimbursement approval of Guardant360\u00ae CDx liquid biopsy test in Japan&#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-767720","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>Guardant Health announces reimbursement approval of Guardant360\u00ae CDx liquid biopsy test in Japan - 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\/guardant-health-announces-reimbursement-approval-of-guardant360-cdx-liquid-biopsy-test-in-japan\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Guardant Health announces reimbursement approval of Guardant360\u00ae CDx liquid biopsy test in Japan - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Guardant Health announces reimbursement approval of Guardant360\u00ae CDx liquid biopsy test in Japan Reimbursement supports expanded access to blood-based comprehensive genomic profiling with Guardant360 CDx for patients with advanced solid tumor cancers and their care teams across Japan PALO ALTO, Calif.&#8211;(BUSINESS WIRE)&#8211; Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360\u00ae CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers. This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022. 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(Nasdaq: GH), a leading precision oncology company, announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW), effective July 24, 2023, for its Guardant360\u00ae CDx liquid biopsy test for comprehensive genomic profiling (CGP) for patients with advanced or metastatic solid tumor cancers. This announcement follows the regulatory approval of the Guardant360 CDx test by the MHLW in March 2022. 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