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Under the prevailing definition, many patients are denied testing for cancer-predisposing genes despite proven accuracy for identifying pathogenic germline variants and clear recommendations for early cancer prevention and diagnosis. Likewise, even with strong evidence that circulating tumor DNA accurately predicts recurrence, major guideline groups often discourage ctDNA assays for minimal residual disease across solid tumors. The article explains why these tests are viewed as lacking utility and argues for broader definitions so more patients can benefit.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/is-it-time-to-expand-our-definition-of-clinical-utility-article/378797/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/is-it-time-to-expand-our-definition-of-clinical-utility-article/378797.png","ImageObject",300,407,{"name":92,"@type":93},"Aria","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-31","2026-09-24",true,{"@type":102,"interactionType":103,"userInteractionCount":52},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Why do genetic tests require proof of “clinical utility” to be recommended?","Question",{"text":112,"@type":113},"Guidelines for cancer care typically recommend tests only after evidence shows they improve clinical decision-making and patient outcomes. Without such proof, payers often deny coverage based on expert panel criteria.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How does the current definition affect access to germline genetic testing?",{"text":117,"@type":113},"Many patients are denied access to tests for cancer-predisposing genes even when germline testing is highly accurate for identifying pathogenic variant carriers and supports early prevention and diagnosis measures. The narrower focus on treatment-directed evidence limits what information patients can receive.",{"name":119,"@type":110,"acceptedAnswer":120},"What is the article’s critique of ctDNA guideline recommendations?",{"text":121,"@type":113},"Although studies show ctDNA after curative-intent therapy is an accurate biomarker for predicting recurrence, major organizations recommend against using ctDNA assays to detect minimal residual disease for all solid tumor malignancies, citing lack of proven clinical utility.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},378797,1790875321,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":52,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":19,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":52},2336464648322,"https://ap-avatar.wpscdn.com/avatar/2200025388227c56fec?_k=1778556882303663488","Is It Time to Expand Our Definition of“Clinical Utility”?  \nCancer Control Volume 30: 1–4  \n© The Author(s) 2023  \nArticle reuse guidelines:  \n[sagepub.com/journals-permissions](sagepub.com/journals-permissions)  \n[DOI: 10.1177/10732748231170483](DOI: 10.1177/10732748231170483)[ ](DOI: 10.1177/10732748231170483)[journals.sagepub.com/home/ccx](journals.sagepub.com/home/ccx)  \nSteven Sorscher, MD􀀁  \nAbstract  \nCurrently, genetic tests that predict cancer risk or risk of recurrence in patients who have had their cancer treated with curative intent must have proven “clinical utility” to be recommended by the organizations responsible for publishing the standard-ofcare guidelines for cancer care.  \nBased on the current definition of clinical utility, most patients are denied testing for cancer-predisposing genes or pathogenic germline variants even though germline testing has been proven as highly accurate in identifying pathogenic germline variant carriers, there are measures recommended to prevent and diagnose early cancers associated with particular PGVs, and disparities in patient access to genetic tests are well described.  \nSimilarly, despite dozens of studies demonstrating that detected circulating tumor DNA (ctDNA) after curative intention therapy of different cancer types is a highly accurate biomarker that predicts recurrence, the major organizations that publish guidelines for cancer monitoring after curative intention therapy recommend against using ctDNA assays to detect minimal residual disease and thereby predict recurrence for all solid tumor malignancies.  \nHere, the primary reasons that these genetic tests are considered to lack proven clinical utility and the primary evidence suggesting that a broader definition of clinical utility should be considered are discussed. By expanding the definition of clinical utility, many patients will benefit from the information gained from having these genetic tests.  \nKeywords  \ncancer guidelines, genetic testing, circulating tumor Deoxyribonucleic acid, clinical utility, biomarker  \nReceived November 16, 2022. Received revised March 10, 2023. Accepted for publication March 23, 2023.  \nCommentary  \nPrecision oncology includes the appropriate application of genetic tests to prevent, detect earlier, diagnose, monitor, and treat cancer. To be recommended, typically a test must be proven to have “clinical utility.” Without proof of clinical utility per a National Comprehensive Cancer Network (NCCN) expert panel, for example, coverage for the costs of that test are typically denied by payers.1 According to the NCCN, clinical utility refers to the ability of the assay to improve clinical decision making and patient outcomes and “even if a marker clearly distinguishes between “positive” and “negative” groups, if evidence for differential treatment isnot available, then no reason exists to test for  \nthe marker”.2 By limiting genetic testing solely to tests that inform treatment decisions, patients are denied information that might be viewed as highly valuable for other reasons.  \nFor example, for patients who have a low pretest probability of testing positive for a cancer-causing pathogenic  \nWake Forest School of Medicine, Winston-Salem, NC, USA  \nCorresponding Author:  \nSteven Sorscher, MD, Retired Professor, Department of Internal Medicine, Oncology Division, Wake Forest School of Medicine, One Medical Center Blvd, Winston-Salem, NC 27157, USA.  \nEmail: [ssorscher1@gmail.com](ssorscher1@gmail.com)  \nCreative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons  \nAttribution-NonCommercial 4.0 License ([https://creativecommons.org/licenses/by-nc/4.0/](https://creativecommons.org/licenses/by-nc/4.0/)) which permits non-commercial use,  \nreproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ([https://us.sagepub.com/en-us/nam/open-access-at-sag","cbCaig6oh5oxaYPe","https://ap.wps.com/l/cbCaig6oh5oxaYPe","pdf",518726,"English","# Abstract\n# Keywords\n# Commentary","[{\"question\":\"Why do genetic tests require proof of “clinical utility” to be recommended?\",\"answer\":\"Guidelines for cancer care typically recommend tests only after evidence shows they improve clinical decision-making and patient outcomes. Without such proof, payers often deny coverage based on expert panel criteria.\"},{\"question\":\"How does the current definition affect access to germline genetic testing?\",\"answer\":\"Many patients are denied access to tests for cancer-predisposing genes even when germline testing is highly accurate for identifying pathogenic variant carriers and supports early prevention and diagnosis measures. The narrower focus on treatment-directed evidence limits what information patients can receive.\"},{\"question\":\"What is the article’s critique of ctDNA guideline recommendations?\",\"answer\":\"Although studies show ctDNA after curative-intent therapy is an accurate biomarker for predicting recurrence, major organizations recommend against using ctDNA assays to detect minimal residual disease for all solid tumor malignancies, citing lack of proven clinical utility.\"}]","Is It Time to Expand Our Definition of \"Clinical Utility\" - Article | PDF",1790232459]