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ACS Adds Shield Blood Test to Colorectal Cancer Screening Guideline

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<p>The American Cancer Society added a blood test to its colorectal cancer screening guideline on Wednesday&comma; May 27&comma; 2026&comma; the first time a venous draw has earned a place alongside colonoscopy and stool kits as a recommended option for adults at average risk who are 45 and older&period; The accepted test is Guardant Health&&num;8217&semi;s Shield&comma; cleared by the US Food and Drug Administration in July 2024&period;<&sol;p>&NewLine;<p>Shield enters the guideline with a qualifier&period; The society recommends it only for patients who decline or cannot complete a colonoscopy or a stool-based test&comma; which makes the population behind that &&num;8216&semi;decline&&num;8217&semi; the audience the update was written for&period;<&sol;p>&NewLine;<h2>What ACS Changed and Who It Was Built For<&sol;h2>&NewLine;<p>The <a href&equals;"https&colon;&sol;&sol;acsjournals&period;onlinelibrary&period;wiley&period;com&sol;doi&sol;10&period;3322&sol;caac&period;70083" target&equals;"&lowbar;blank" rel&equals;"noopener">updated guideline in CA&colon; A Cancer Journal for Clinicians<&sol;a> reaffirms that average-risk adults should begin colorectal screening at 45 and continue through 75 if life expectancy is at least 10 years&period; What changed is the option set&period; Adults can now choose&comma; in addition to a colonoscopy or a fecal immunochemical test&comma; a blood draw at the doctor&&num;8217&semi;s office&period; Shield is <strong>the first venous draw to be recommended by the society for primary screening<&sol;strong>&period;<&sol;p>&NewLine;<p>Two stool tests also joined the list&period; Cologuard Plus&comma; the next-generation update of Exact Sciences&&num;8217&semi; multitarget stool DNA assay&comma; <a href&equals;"https&colon;&sol;&sol;www&period;exactsciences&period;com&sol;newsroom&sol;press-releases&sol;fda-approves-exact-sciences-cologuard-plus-test" target&equals;"&lowbar;blank" rel&equals;"noopener">received FDA approval on October 4&comma; 2024<&sol;a>&period; ColoSense&comma; developed by Geneoscopy&comma; was cleared in May 2024&period; Both are at-home collection kits that look for molecular markers and hidden blood&comma; then ship to a central lab&period;<&sol;p>&NewLine;<p>The reasoning is direct&period; &&num;8220&semi;There are a lot of people who can&&num;8217&semi;t or won&&num;8217&semi;t do a colonoscopy&comma; or the idea of collecting their own stool for testing&comma; they just won&&num;8217&semi;t do&comma;&&num;8221&semi; said William Dahut&comma; chief scientific officer of the American Cancer Society&period; &&num;8220&semi;Having more options hopefully will allow more people to be screened to find cancers earlier on&comma; and we&&num;8217&semi;ll be able to cure more patients&period;&&num;8221&semi;<&sol;p>&NewLine;<p>The gap Dahut is talking about is large&period; The most recent <a href&equals;"https&colon;&sol;&sol;www&period;cdc&period;gov&sol;pcd&sol;issues&sol;2025&sol;25&lowbar;0175&period;htm" target&equals;"&lowbar;blank" rel&equals;"noopener">baseline estimates from the Centers for Disease Control and Prevention<&sol;a> put up-to-date colorectal screening among adults aged 45 to 75 at 63&period;5&percnt; in 2023&period; Roughly one in three eligible Americans is therefore behind on a test that&comma; if a tumor is caught at stage I or II&comma; predicts a five-year survival rate above 90&percnt;&period;<&sol;p>&NewLine;<figure class&equals;"wp-block-image aligncenter featured-image" style&equals;"margin&colon;1&period;5em auto&semi;text-align&colon;center&semi;"><img class&equals;"aligncenter" src&equals;"https&colon;&sol;&sol;budgyapp&period;com&sol;wp-content&sol;uploads&sol;2026&sol;05&sol;blood-based-colorectal-cancer-screening-test-added-to-american-cancer-society-gu&period;webp" alt&equals;"Blood-based colorectal cancer screening test added to American Cancer Society guideline&period;" style&equals;"width&colon;100&percnt;&semi;max-width&colon;800px&semi;height&colon;auto&semi;border-radius&colon;8px&semi;display&colon;block&semi;margin&colon;0 auto&semi;" &sol;><figcaption style&equals;"text-align&colon;center&semi;font-size&colon;0&period;85em&semi;color&colon;&num;888&semi;margin-top&colon;0&period;5em&semi;">Blood-based colorectal cancer screening test added to American Cancer Society guideline&period;<&sol;figcaption><&sol;figure>&NewLine;<h2>The Three New Tests Compared<&sol;h2>&NewLine;<p>The three additions sit at very different points on the convenience-versus-sensitivity curve&period; A colonoscopy still anchors the top of that curve&period; Among at-home options&comma; the gap between blood and stool DNA shows up cleanly in the trial data&period;<&sol;p>&NewLine;<table>&NewLine;<thead>&NewLine;<tr>&NewLine;<th>Test<&sol;th>&NewLine;<th>Sample type<&sol;th>&NewLine;<th>FDA cleared<&sol;th>&NewLine;<th>Cancer sensitivity<&sol;th>&NewLine;<th>Advanced precancer sensitivity<&sol;th>&NewLine;<th>Frequency<&sol;th>&NewLine;<&sol;tr>&NewLine;<&sol;thead>&NewLine;<tbody>&NewLine;<tr>&NewLine;<td>Shield &lpar;Guardant Health&rpar;<&sol;td>&NewLine;<td>Blood draw<&sol;td>&NewLine;<td>July 2024<&sol;td>&NewLine;<td>83&percnt;<&sol;td>&NewLine;<td>13&percnt;<&sol;td>&NewLine;<td>Every 3 years<&sol;td>&NewLine;<&sol;tr>&NewLine;<tr>&NewLine;<td>Cologuard Plus &lpar;Exact Sciences&rpar;<&sol;td>&NewLine;<td>Stool&comma; at home<&sol;td>&NewLine;<td>October 2024<&sol;td>&NewLine;<td>93&period;9&percnt;<&sol;td>&NewLine;<td>43&period;4&percnt;<&sol;td>&NewLine;<td>Every 3 years<&sol;td>&NewLine;<&sol;tr>&NewLine;<tr>&NewLine;<td>ColoSense &lpar;Geneoscopy&rpar;<&sol;td>&NewLine;<td>Stool&comma; at home<&sol;td>&NewLine;<td>May 2024<&sol;td>&NewLine;<td>93&percnt;<&sol;td>&NewLine;<td>45&percnt;<&sol;td>&NewLine;<td>Every 3 years<&sol;td>&NewLine;<&sol;tr>&NewLine;<tr>&NewLine;<td>Colonoscopy<&sol;td>&NewLine;<td>Endoscopic exam<&sol;td>&NewLine;<td>Standard procedure<&sol;td>&NewLine;<td>Above 95&percnt;<&sol;td>&NewLine;<td>Above 95&percnt;<&sol;td>&NewLine;<td>Every 10 years<&sol;td>&NewLine;<&sol;tr>&NewLine;<&sol;tbody>&NewLine;<&sol;table>&NewLine;<p>Stool DNA tests pick up more than nine in ten cancers and roughly four in ten advanced adenomas&comma; the polyps that&comma; if removed&comma; prevent a cancer from forming&period; Shield catches <strong>83&percnt; of cancers<&sol;strong>&comma; the rate published in the ECLIPSE trial in The New England Journal of Medicine in March 2024&comma; but the same dataset showed it identified only 13&percnt; of advanced precancerous lesions&period; A colonoscopy&comma; by contrast&comma; sees the lesion and removes it in one visit&period;<&sol;p>&NewLine;<p>For a patient who would otherwise skip the year entirely&comma; the trade-off changes meaning&period; Detection at any stage beats detection at no stage&period;<&sol;p>&NewLine;<h2>The Sensitivity Gap Behind the Convenience<&sol;h2>&NewLine;<p>Most colorectal cancers begin as a polyp&period; The cell line takes between five and fifteen years to turn malignant&comma; and the entire reason colonoscopy is the standard is that the endoscopist can spot the polyp and snip it during the same procedure&period; Stool DNA tests can flag the molecular signature of a precancer&semi; a positive result then triggers a follow-up colonoscopy&period; Either path catches the disease before it becomes a disease&period;<&sol;p>&NewLine;<p>Blood-based screening sits one step further out&period; Tumors shed cell-free DNA into the bloodstream only once they reach a certain size&comma; which is why Shield&&num;8217&semi;s sensitivity drops sharply for the smaller&comma; precancerous lesion&period; The ECLIPSE expansion data put <strong>advanced adenoma sensitivity at 13&percnt;<&sol;strong>&period;<&sol;p>&NewLine;<p>Ursina Teitelbaum&comma; professor of gastrointestinal oncology at the University of Pennsylvania and section chief of gastrointestinal cancers at Penn Medicine&comma; framed the trade-off in written comments&period; She called the guideline forward-thinking and reality-based&period;<&sol;p>&NewLine;<blockquote>&NewLine;<p>The test remains another option&comma; albeit imperfect since it may miss early-stage cancers and precancerous lesions&period; It all harkens&comma; though&comma; to &&num;8216&semi;perfect is the enemy of good&comma;&&num;8217&semi; and these new guidelines acknowledge the need to broaden the capture of screening&comma; particularly in younger&comma; vulnerable populations&period;<&sol;p>&NewLine;<&sol;blockquote>&NewLine;<p>Teitelbaum was not part of the panel that wrote the updated guideline&period; The same logic appears in the guideline text itself&colon; the authors recommend blood-based tests only for patients who decline or do not complete preferred screening&period; Scott Kopetz&comma; gastrointestinal medical oncologist at The University of Texas MD Anderson Cancer Center&comma; made the point in an email that patients otherwise willing to undergo a colonoscopy or stool test should not swap to a blood draw&period;<&sol;p>&NewLine;<h2>Why Newly Eligible Adults Are the Hidden Variable<&sol;h2>&NewLine;<p>The screening calendar was lowered from 50 to 45 in 2021&comma; when the US Preventive Services Task Force and the American Cancer Society aligned on the earlier start in response to rising rates of young-onset disease&period; Five years later&comma; that newly eligible cohort is the demographic least likely to have followed through&period;<&sol;p>&NewLine;<p>Adults aged 45 to 49 sit at a <strong>20&percnt; up-to-date screening rate<&sol;strong>&comma; by far the lowest band in the 45-to-75 window the guideline covers&period; The roughly 35&percnt; of eligible Americans who remain behind on screening is concentrated heavily in that early cohort&comma; in Asian Americans &lpar;50&percnt; screened&rpar;&comma; and in the uninsured &lpar;21&percnt; screened&rpar;&period;<&sol;p>&NewLine;<p>A blood draw at an annual physical sidesteps several of the barriers that keep that group out of the system&colon;<&sol;p>&NewLine;<ul>&NewLine;<li>No bowel prep&comma; no clear-liquid diet&comma; no day off work for sedation recovery<&sol;li>&NewLine;<li>No fecal sample to collect at home and ship<&sol;li>&NewLine;<li>A test that can be ordered&comma; drawn&comma; and billed in the same primary-care visit<&sol;li>&NewLine;<li>A result that arrives before the patient has time to second-guess the appointment<&sol;li>&NewLine;<&sol;ul>&NewLine;<p>A 46-year-old who keeps postponing a first colonoscopy because of squeamishness is the patient who will say yes to a venous draw&period; The clinical question is whether 83&percnt; sensitivity for cancer&comma; with 13&percnt; sensitivity for the precancerous lesion&comma; captures enough of that group&&num;8217&semi;s eventual disease to be worth recommending over no test at all&period; The authors of the updated guideline argue that it does&comma; on the math that a moderately sensitive test most refusers will complete outperforms a near-perfect test the same patients will not&period;<&sol;p>&NewLine;<h2>Guardant Health Gets a Coverage Pathway<&sol;h2>&NewLine;<p>The clinical guideline matters most to patients&comma; but it travels straight into the reimbursement code books&period; The Centers for Medicare and Medicaid Services pays for blood-based colorectal screening every three years for average-risk adults 45 and older when the test is FDA-approved and listed in major society guidelines&period; Shield was <a href&equals;"https&colon;&sol;&sol;investors&period;guardanthealth&period;com&sol;press-releases&sol;press-releases&sol;2025&sol;Guardant-Health-Receives-ADLT-Status-From-CMS-for-Shield-Blood-Test&sol;default&period;aspx" target&equals;"&lowbar;blank" rel&equals;"noopener">granted Advanced Diagnostic Laboratory Test status by CMS in 2025<&sol;a>&comma; setting an initial reimbursement of &dollar;1&comma;495 per test&period; The American Cancer Society&&num;8217&semi;s update gives Shield the second leg of the coverage equation&period;<&sol;p>&NewLine;<p>The Shield approval rests on the ECLIPSE study&comma; a registrational trial that <a href&equals;"https&colon;&sol;&sol;www&period;cancer&period;gov&sol;news-events&sol;cancer-currents-blog&sol;2024&sol;shield-blood-test-colorectal-cancer-screening" target&equals;"&lowbar;blank" rel&equals;"noopener">enrolled more than 20&comma;000 average-risk patients<&sol;a> and published in The New England Journal of Medicine in March 2024&period; Shield&&num;8217&semi;s most recent algorithm version&comma; Shield V2&comma; reports 84&percnt; sensitivity for cancer at 90&percnt; specificity&comma; with stage I sensitivity of 62&percnt;&period; Guardant Health has said its next-generation test&comma; in development&comma; targets improved precancer detection&period;<&sol;p>&NewLine;<p>Kopetz&comma; the MD Anderson oncologist&comma; predicted the category will keep expanding&period; &&num;8220&semi;This is the first blood-based test&comma; but won&&num;8217&semi;t be the last&comma; and the hope is that future tests will continue to reduce the barriers to access to effective screening and will have improved performance&comma;&&num;8221&semi; he wrote&period; &&num;8220&semi;The technology will only improve from here&period;&&num;8221&semi; Freenome and Exact Sciences both have blood-based colorectal assays in trials&comma; and several other companies are in earlier-stage development&semi; none of them carry the guideline placement Shield now has&period; If the second-generation tests close the precancer-sensitivity gap to within range of stool DNA&comma; the third-tier fence in the current guideline becomes harder to justify&period;<&sol;p>&NewLine;<h2>Frequently Asked Questions<&sol;h2>&NewLine;<h3>Who Qualifies for the Shield Blood Test under the New Guideline&quest;<&sol;h3>&NewLine;<p>Adults aged 45 and older at average risk for colorectal cancer who have declined or have not completed a colonoscopy&comma; a fecal immunochemical test&comma; or a stool DNA test&period; The blood test is not recommended for patients with a family history of colorectal cancer&comma; prior polyps&comma; inflammatory bowel disease&comma; or other higher-risk conditions&period; Those patients should continue with colonoscopy on the schedule their physician sets&period;<&sol;p>&NewLine;<h3>How Often Should the Shield Test Be Repeated&quest;<&sol;h3>&NewLine;<p>Every three years if the result is negative&period; A positive Shield result must be followed by a diagnostic colonoscopy&comma; the same protocol that applies after a positive stool-based test&period; The follow-up colonoscopy is what catches the lesion and&comma; in many cases&comma; removes it&period;<&sol;p>&NewLine;<h3>Is the Shield Test Covered by Medicare or Private Insurance&quest;<&sol;h3>&NewLine;<p>Yes for Medicare Fee-for-Service patients age 45 and older&comma; with &dollar;0 out-of-pocket cost during the current ADLT pricing period&period; Medicare Advantage co-pays and deductibles vary by plan&period; Private insurance coverage is rolling out&semi; most commercial plans align with major society guidelines&comma; so the American Cancer Society update is expected to expand coverage over the next several quarters&period; Patients should confirm with the ordering office before the blood draw&period;<&sol;p>&NewLine;<h3>Does a Negative Blood Test Mean I Do Not Have Colorectal Cancer&quest;<&sol;h3>&NewLine;<p>No&period; A negative Shield result lowers the probability but does not rule out the disease&period; The test misses roughly 17&percnt; of cancers and the majority of advanced precancerous polyps&period; Patients with new symptoms &lpar;rectal bleeding&comma; persistent change in bowel habits&comma; unexplained weight loss&comma; iron-deficiency anemia&rpar; should consult a clinician regardless of a recent negative screening result&period;<&sol;p>&NewLine;<h3>How Does the Cost Compare with a Colonoscopy&quest;<&sol;h3>&NewLine;<p>Shield&&num;8217&semi;s list cash-pay price is &dollar;1&comma;495 per test&period; A screening colonoscopy in the United States typically ranges between &dollar;1&comma;250 and &dollar;4&comma;800 depending on facility and insurance contract&period; Cologuard Plus carries a list price under &dollar;1&comma;000&period; Out-of-pocket cost for any of these depends on coverage&comma; deductible&comma; and whether a follow-up colonoscopy is needed&period;<&sol;p>&NewLine;<h3>Where Can I Read the Full Updated Guideline&quest;<&sol;h3>&NewLine;<p>The full update is published open-access in CA&colon; A Cancer Journal for Clinicians&comma; the peer-reviewed journal of the American Cancer Society&period; <a href&equals;"https&colon;&sol;&sol;pressroom&period;cancer&period;org&sol;colorectal-cancer-screening-guideline-update-2026" target&equals;"&lowbar;blank" rel&equals;"noopener">The society&&num;8217&semi;s pressroom summary<&sol;a> outlines the rationale and lists all recommended testing options with their intervals&period;<&sol;p>&NewLine;<p><script type&equals;"application&sol;ld&plus;json">&NewLine;&lbrace;&NewLine; "&commat;context"&colon; "https&colon;&sol;&sol;schema&period;org"&comma;&NewLine; "&commat;type"&colon; "FAQPage"&comma;&NewLine; "mainEntity"&colon; &lbrack;&NewLine; &lbrace;&NewLine; "&commat;type"&colon; "Question"&comma;&NewLine; "name"&colon; "Who qualifies for the Shield blood test under the new guideline&quest;"&comma;&NewLine; "acceptedAnswer"&colon; &lbrace;&NewLine; "&commat;type"&colon; "Answer"&comma;&NewLine; "text"&colon; "Adults aged 45 and older at average risk for colorectal cancer who have declined or have not completed a colonoscopy&comma; a fecal immunochemical test&comma; or a stool DNA test&period; The blood test is not recommended for patients with a family history of colorectal cancer&comma; prior polyps&comma; inflammatory bowel disease&comma; or other higher-risk conditions&period; Those patients should continue with colonoscopy on the schedule their physician sets&period;"&NewLine; &rcub;&NewLine; &rcub;&comma;&NewLine; &lbrace;&NewLine; "&commat;type"&colon; "Question"&comma;&NewLine; "name"&colon; "How often should the Shield test be repeated&quest;"&comma;&NewLine; "acceptedAnswer"&colon; &lbrace;&NewLine; "&commat;type"&colon; "Answer"&comma;&NewLine; "text"&colon; "Every three years if the result is negative&period; A positive Shield result must be followed by a diagnostic colonoscopy&comma; the same protocol that applies after a positive stool-based test&period; The follow-up colonoscopy is what catches the lesion and&comma; in many cases&comma; removes it&period;"&NewLine; &rcub;&NewLine; &rcub;&comma;&NewLine; &lbrace;&NewLine; "&commat;type"&colon; "Question"&comma;&NewLine; "name"&colon; "Is the Shield test covered by Medicare or private insurance&quest;"&comma;&NewLine; "acceptedAnswer"&colon; &lbrace;&NewLine; "&commat;type"&colon; "Answer"&comma;&NewLine; "text"&colon; "Yes for Medicare Fee-for-Service patients age 45 and older&comma; with &dollar;0 out-of-pocket cost during the current ADLT pricing period&period; Medicare Advantage co-pays and deductibles vary by plan&period; Private insurance coverage is rolling out&semi; most commercial plans align with major society guidelines&comma; so the American Cancer Society update is expected to expand coverage over the next several quarters&period; Patients should confirm with the ordering office before the blood draw&period;"&NewLine; &rcub;&NewLine; &rcub;&comma;&NewLine; &lbrace;&NewLine; "&commat;type"&colon; "Question"&comma;&NewLine; "name"&colon; "Does a negative blood test mean I do not have colorectal cancer&quest;"&comma;&NewLine; "acceptedAnswer"&colon; &lbrace;&NewLine; "&commat;type"&colon; "Answer"&comma;&NewLine; "text"&colon; "No&period; A negative Shield result lowers the probability but does not rule out the disease&period; The test misses roughly 17&percnt; of cancers and the majority of advanced precancerous polyps&period; Patients with new symptoms &lpar;rectal bleeding&comma; persistent change in bowel habits&comma; unexplained weight loss&comma; iron-deficiency anemia&rpar; should consult a clinician regardless of a recent negative screening result&period;"&NewLine; &rcub;&NewLine; &rcub;&comma;&NewLine; &lbrace;&NewLine; "&commat;type"&colon; "Question"&comma;&NewLine; "name"&colon; "How does the cost compare with a colonoscopy&quest;"&comma;&NewLine; "acceptedAnswer"&colon; &lbrace;&NewLine; "&commat;type"&colon; "Answer"&comma;&NewLine; "text"&colon; "Shield's list cash-pay price is &dollar;1&comma;495 per test&period; A screening colonoscopy in the United States typically ranges between &dollar;1&comma;250 and &dollar;4&comma;800 depending on facility and insurance contract&period; Cologuard Plus carries a list price under &dollar;1&comma;000&period; Out-of-pocket cost for any of these depends on coverage&comma; deductible&comma; and whether a follow-up colonoscopy is needed&period;"&NewLine; &rcub;&NewLine; &rcub;&comma;&NewLine; &lbrace;&NewLine; "&commat;type"&colon; "Question"&comma;&NewLine; "name"&colon; "Where can I read the full updated guideline&quest;"&comma;&NewLine; "acceptedAnswer"&colon; &lbrace;&NewLine; "&commat;type"&colon; "Answer"&comma;&NewLine; "text"&colon; "The full update is published open-access in CA&colon; A Cancer Journal for Clinicians&comma; the peer-reviewed journal of the American Cancer Society&period; The society's pressroom summary outlines the rationale and lists all recommended testing options with their intervals&period;"&NewLine; &rcub;&NewLine; &rcub;&NewLine; &rsqb;&NewLine;&rcub;&NewLine;<&sol;script><&sol;p>&NewLine;<p><strong><em>Disclaimer&colon;<&sol;em><&sol;strong> <em>This article is for informational purposes only and does not constitute medical advice&period; Cancer screening decisions involve personal risk factors&comma; family history&comma; and clinical considerations that vary between patients&semi; consult a licensed physician or qualified healthcare professional before choosing or changing a screening test&period; Figures&comma; pricing&comma; and guideline language are accurate as of publication on May 28&comma; 2026&period;<&sol;em><&sol;p>&NewLine;

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