{"id":53815,"date":"2023-02-09T23:02:11","date_gmt":"2023-02-09T22:02:11","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/prospective-multicenter-study-demonstrates-that-decisiondx-melanoma-test-results-can-significantly-reduce-the-number-of-sentinel-lymph-node-biopsy-slnb-procedures-performed-when-used-within-t\/"},"modified":"2023-02-09T23:02:11","modified_gmt":"2023-02-09T22:02:11","slug":"prospective-multicenter-study-demonstrates-that-decisiondx-melanoma-test-results-can-significantly-reduce-the-number-of-sentinel-lymph-node-biopsy-slnb-procedures-performed-when-used-within-t","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/prospective-multicenter-study-demonstrates-that-decisiondx-melanoma-test-results-can-significantly-reduce-the-number-of-sentinel-lymph-node-biopsy-slnb-procedures-performed-when-used-within-t\/","title":{"rendered":"Prospective, Multicenter Study Demonstrates That DecisionDx\u00ae-Melanoma Test Results Can Significantly Reduce the Number of Sentinel Lymph Node Biopsy (SLNB) Procedures Performed When Used Within the Context of Current Guidelines"},"content":{"rendered":"<div>\n<p>FRIENDSWOOD, Texas&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/search?q=%24CSTL&amp;src=ctag\" target=\"_blank\" rel=\"noopener\">$CSTL<\/a> <a href=\"https:\/\/twitter.com\/hashtag\/CSTL?src=hash\" target=\"_blank\" rel=\"noopener\">#CSTL<\/a>&#8211;Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of data from a prospective, multicenter study, called DECIDE.<sup>1,2<\/sup> In the study, DecisionDx\u00ae-Melanoma test results influenced 85% of clinicians\u2019 decisions regarding the sentinel lymph node biopsy (SLNB) surgical procedure. Additionally, use of the tests\u2019 results within current guideline recommendations led to a significant reduction in SLNB procedures performed, demonstrating the potential clinical value of the test to guide risk-aligned patient care.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230209005587\/en\/1710179\/5\/CastleLogo2Color.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230209005587\/en\/1710179\/21\/CastleLogo2Color.jpg\"><\/a><\/p>\n<p>\n\u201cDecisionDx-Melanoma is the best-studied molecular test for use in cutaneous melanoma to date, with studies involving more than 10,000 research subjects. DecisionDx-Melanoma provides personalized information about a patient\u2019s risk of sentinel lymph node (SLN) positivity to inform decisions about whether to safely forego or pursue an SLNB,\u201d said Maki Yamamoto, M.D., board-certified surgical oncologist and associate professor of surgery at the University of California-Irvine School of Medicine in Orange, California. \u201cThe data from this prospective, multicenter study showed that clinicians who used the test performed fewer SLNBs overall, which can alleviate complication rates and high costs associated with the procedure, and focus surgical procedures on patients who have a greater likelihood of being SLN positive.\u201d\n<\/p>\n<p>\n\u201cWe believe DecisionDx-Melanoma has the ability to influence management decisions based on ample evidence provided in more than 40 peer-reviewed studies and the experience of clinical use in more than 120,000 patients,&#8221; said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. &#8220;We also believe that the use of molecular tests to guide clinical decisions adds value that is independent from the clinicopathologic risk factors traditionally used in melanoma risk assessment. We are pleased the DECIDE study results showed that using our DecisionDx-Melanoma test in combination with clinicopathologic features demonstrated superiority over the use of clinicopathologic factors alone to guide appropriate decisions about SLNB use.\u201d<sup>3<\/sup>\n<\/p>\n<p>\n<i>Study highlights:<\/i>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSLNB surgery is an invasive surgical procedure that is used for risk-stratification purposes; according to recent studies, the procedure returns a surgical result that is negative for metastatic spread in up to 88% of patients and has a reported complication rate of 11%.<sup>4,5<\/sup>\n<\/li>\n<li>\nThis prospective, multicenter study included patients with invasive cutaneous melanoma who were being considered for an SLNB procedure and had a T-stage of:<\/p>\n<ul class=\"bwlistcircle\">\n<li>\nT1a (and at least one adverse, high-risk feature),\n<\/li>\n<li>\nT1b or\n<\/li>\n<li>\nT2.\n<\/li>\n<\/ul>\n<\/li>\n<li>\nClinicians received DecisionDx-Melanoma test results prior to making final SLNB decisions and were asked which features influenced their decision on whether to perform the procedure. Potential influencing factors included DecisionDx-Melanoma test results, patient preference and clinical and pathological features.\n<\/li>\n<li>\nThe data showed that <b>DecisionDx-Melanoma test results influenced 85% of SLNB decisions<\/b>, the highest percentage reported in the study, followed by patient preference.<\/p>\n<ul class=\"bwlistcircle\">\n<li>\nWhen DecisionDx-Melanoma test results influenced <i>for<\/i> SLNB, the procedure was performed in 92% of the cases in the study; similarly, when the test result influenced <i>against<\/i> SLNB, the decision was made to forego SLNB in 70% of cases. These data show that use of the test\u2019s results can guide risk-aligned, clinical decision-making regarding the SLNB surgical procedure, within current guidelines. Of the remaining 30% of cases where the clinician&#8217;s decision was influenced by DecisionDx-Melanoma test results to forego SLNB but the biopsy was performed, 83% were influenced by patient preference.\n<\/li>\n<\/ul>\n<\/li>\n<li>\nPatients receiving a high-risk (Class 2B) DecisionDx-Melanoma test result had a 22% SLN positivity rate, more than double the historical positivity rate in this patient population.\n<\/li>\n<li>\nThe <b>use of DecisionDx-Melanoma test results within current guidelines resulted in a significant reduction in SLNB procedures performed<\/b>, compared to SLNB decisions based on a patient\u2019s clinicopathologic risk factors alone (p&lt;0.01).\n<\/li>\n<\/ul>\n<p>\nThe publication can be found <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.tandfonline.com%2Fdoi%2Ffull%2F10.1080%2F03007995.2023.2165813&amp;esheet=53313973&amp;newsitemid=20230209005587&amp;lan=en-US&amp;anchor=here&amp;index=1&amp;md5=94cd15dd9bcf4da7e40f60c39953aba9\" rel=\"nofollow noopener\" shape=\"rect\">here<\/a>.\n<\/p>\n<p>\n<b>About DecisionDx\u00ae-Melanoma<\/b>\n<\/p>\n<p>\nDecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient\u2019s individual risk of sentinel lymph node (SLN) positivity and a patient&#8217;s personal risk of melanoma recurrence and\/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma\u2019s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test\u2019s results. Through Dec. 31, 2022, DecisionDx-Melanoma has been ordered 120,287 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.castletestinfo.com%2F&amp;esheet=53313973&amp;newsitemid=20230209005587&amp;lan=en-US&amp;anchor=www.CastleTestInfo.com&amp;index=2&amp;md5=be25b996890d5a71966d3d47c457e21b\" rel=\"nofollow noopener\" shape=\"rect\">www.CastleTestInfo.com<\/a>.\n<\/p>\n<p>\n<b>About Castle Biosciences<\/b>\n<\/p>\n<p>\nCastle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.\n<\/p>\n<p>\nCastle\u2019s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett\u2019s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.CastleBiosciences.com&amp;esheet=53313973&amp;newsitemid=20230209005587&amp;lan=en-US&amp;anchor=www.CastleBiosciences.com&amp;index=3&amp;md5=b009dd5bac922030b9dd45d49ed1b495\" rel=\"nofollow noopener\" shape=\"rect\">www.CastleBiosciences.com<\/a> and connect with us on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fcastle-biosciences-inc-%2F&amp;esheet=53313973&amp;newsitemid=20230209005587&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=4&amp;md5=1391340d6ff008940afa1dd7ad6910d4\" rel=\"nofollow noopener\" shape=\"rect\">LinkedIn<\/a>, <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2Fcastlebiosciences%2F&amp;esheet=53313973&amp;newsitemid=20230209005587&amp;lan=en-US&amp;anchor=Facebook&amp;index=5&amp;md5=88b761d8f40fe434ccbfc821f87d2829\" rel=\"nofollow noopener\" shape=\"rect\">Facebook<\/a>, <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Fcastlebio%3Flang%3Den&amp;esheet=53313973&amp;newsitemid=20230209005587&amp;lan=en-US&amp;anchor=Twitter&amp;index=6&amp;md5=46d2c89cc750734d3d58a66c6206685d\" rel=\"nofollow noopener\" shape=\"rect\">Twitter<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Fcastlebiosciences%2F&amp;esheet=53313973&amp;newsitemid=20230209005587&amp;lan=en-US&amp;anchor=Instagram&amp;index=7&amp;md5=fff35f77c070d845b22bdd08009bda5c\" rel=\"nofollow noopener\" shape=\"rect\">Instagram<\/a>.\n<\/p>\n<p>\nDecisionDx-Melanoma, DecisionDx-CM<i>Seq<\/i>, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UM<i>Seq<\/i>, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc.\n<\/p>\n<p>\n<b>Forward-Looking Statements<\/b>\n<\/p>\n<p>\n<i>This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the \u201csafe harbor\u201d created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of DecisionDx-Melanoma test results to (i) when used within the context of current guidelines, significantly reduce the number of SLNB procedures performed; (ii) provide clinical value and guide risk-aligned patient care and clinical decision-making regarding the SLNB surgical procedure; (iii) alleviate complication rates and high costs associated with the SLNB procedure, and focus surgical procedures on patients who have a greater likelihood of being SLN positive; and (iv) demonstrate the test\u2019s added value that is independent from important clinicopathologic risk factors traditionally used in melanoma risk assessments. The words \u201cbelieve,\u201d \u201ccan,\u201d \u201cpotential,\u201d \u201cwill\u201d and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in this study, including with respect to the discussion of DecisionDx-Melanoma in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading \u201cRisk Factors\u201d in our Quarterly Report on Form 10-Q for the three months ended September 30, 2022, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.<\/i>\n<\/p>\n<ol class=\"bwlistdecimal\">\n<li>\nDECIDE: DecisionDx-Melanoma Impact on Sentinel Lymph Node Biopsy Decisions and Clinical Outcomes\n<\/li>\n<li>\nYamamoto M, Sickle-Santanello B, Beard T, et al. The 31-gene expression profile test informs sentinel lymph node biopsy decisions in patients with cutaneous melanoma: results of a prospective, multicenter study [published online ahead of print, 2023 Jan 16]. <i>Curr Med Res Opin<\/i>. 2023;1-7. doi:10.1080\/03007995.2023.2165813\n<\/li>\n<li>\nGlazer AM, Tassavor M, Portela D, et al. The Integrated 31-Gene Expression Profile Test (i31-GEP) for Cutaneous Melanoma Outperforms the CP-GEP at Identifying Patients who can Forego Sentinel Lymph Node Biopsy when Applying NCCN Guidelines. <i>SKIN J Cutan Med <\/i>2022; 6(6):474\u2013481. doi: https:\/\/doi.org\/10.25251\/skin.6.6.4\n<\/li>\n<li>\nChen J, Xu Y, Zhou Y, et al. Prognostic role of sentinel lymph node biopsy for patients with cutaneous melanoma: a retrospective study of surveillance, epidemiology, and end-result population-based data. <i>Oncotarget<\/i>. 2016;7:45671\u201345677.\n<\/li>\n<li>\nMoody JA, Ali RF, Carbone AC, et al. Complications of sentinel lymph node biopsy for melanoma \u2013 a systematic review of the literature. <i>Eur J Surg Oncol<\/i>. 2017;43(2):270\u2013277.\n<\/li>\n<\/ol>\n<p>\n\u00a0\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Investor Contact:<\/b><br \/>Camilla Zuckero<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;lt&#x6f;&#x3a;&#99;&#122;u&#x63;&#x6b;&#101;&#114;o&#x40;&#x63;&#x61;&#115;tl&#x65;&#x62;&#105;&#111;s&#x63;&#x69;&#101;&#110;c&#x65;&#x73;&#46;&#99;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#99;&#x7a;u&#99;&#x6b;&#101;&#x72;o&#64;&#x63;a&#x73;&#x74;&#108;&#x65;b&#105;&#x6f;s&#x63;&#x69;&#101;&#x6e;c&#101;&#x73;&#46;&#x63;o&#109;<\/a>\n<\/p>\n<p>\n<b>Media Contact:<\/b><br \/>Allison Marshall<br \/>\n<br \/><a target=\"_blank\" href=\"mail&#116;&#111;&#58;&#97;&#109;&#97;&#114;&#x73;&#x68;&#x61;&#x6c;&#x6c;&#x40;&#x63;&#x61;&#x73;tleb&#105;&#111;&#115;&#99;&#105;&#101;&#110;&#x63;&#x65;&#x73;&#x2e;&#x63;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#97;&#x6d;&#97;&#x72;&#115;&#x68;&#97;&#x6c;&#108;&#x40;&#99;&#x61;&#115;&#x74;&#108;&#x65;&#98;&#x69;&#111;&#x73;&#99;&#x69;&#101;&#x6e;&#99;&#x65;s&#x2e;c&#x6f;m<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>FRIENDSWOOD, Texas&#8211;(BUSINESS WIRE)&#8211;$CSTL #CSTL&#8211;Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of data from a prospective, multicenter study, called DECIDE.1,2 In the study, DecisionDx\u00ae-Melanoma test results influenced 85% of clinicians\u2019 decisions regarding the sentinel lymph node biopsy (SLNB) surgical procedure. Additionally, use of &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/prospective-multicenter-study-demonstrates-that-decisiondx-melanoma-test-results-can-significantly-reduce-the-number-of-sentinel-lymph-node-biopsy-slnb-procedures-performed-when-used-within-t\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53815","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Prospective, Multicenter Study Demonstrates That DecisionDx\u00ae-Melanoma Test Results Can Significantly Reduce the Number of Sentinel Lymph Node Biopsy (SLNB) Procedures Performed When Used Within the Context of Current Guidelines - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/prospective-multicenter-study-demonstrates-that-decisiondx-melanoma-test-results-can-significantly-reduce-the-number-of-sentinel-lymph-node-biopsy-slnb-procedures-performed-when-used-within-t\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Prospective, Multicenter Study Demonstrates That DecisionDx\u00ae-Melanoma Test Results Can Significantly Reduce the Number of Sentinel Lymph Node Biopsy (SLNB) Procedures Performed When Used Within the Context of Current Guidelines - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"FRIENDSWOOD, Texas&#8211;(BUSINESS WIRE)&#8211;$CSTL #CSTL&#8211;Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of data from a prospective, multicenter study, called DECIDE.1,2 In the study, DecisionDx\u00ae-Melanoma test results influenced 85% of clinicians\u2019 decisions regarding the sentinel lymph node biopsy (SLNB) surgical procedure. Additionally, use of ... 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