Blood Tests Added to Official Screening Recommendations for Colorectal Cancer

For the first time, a blood test is now part of official colorectal cancer screening guidelines in the United States. On May 27, 2026, the American Cancer Society updated its recommendations to include Guardant Health's Shield test — an FDA-approved blood draw that detects tumor DNA circulating in the bloodstream — as a screening option for average-risk adults aged 45 to 75 [1][2]. The update also added two new stool-based tests: an updated multi-target stool DNA test (Cologuard Plus) and a new multi-target stool RNA test (ColoSense), both recommended at three-year intervals [1].

But the ACS placed a critical qualifier on the blood test: it is not a preferred screening method. Shield is recommended only for individuals who "decline or do not complete" colonoscopy or stool-based tests [1][3]. The reason is straightforward — the blood test catches far fewer cancers and precancerous growths than the alternatives.

What the Blood Test Can and Cannot Do

Shield works by detecting cell-free DNA shed by colorectal tumors into the bloodstream. In the ECLIPSE registrational trial — a study of more than 20,000 average-risk adults published in The New England Journal of Medicine in March 2024 — the test demonstrated 83% sensitivity for colorectal cancer and 90% specificity for advanced neoplasia [4][5]. An updated analysis, Shield V2, showed similar performance: 84% sensitivity and 90% specificity for CRC detection [6].

Those numbers look reasonable in isolation. But they obscure a far more consequential gap: Shield detected only 13% of advanced adenomas, the precancerous polyps that colonoscopy is specifically designed to find and remove [5][7]. Colonoscopy, by contrast, picks up roughly 95% of dangerous polyps and can remove them during the same procedure [8]. The multi-target stool DNA test (Cologuard) detects about 92% of cancers [5].

Source: NEJM / FDA Clinical Data

Data as of May 27, 2026CSV

Shield also has limited detection of early-stage disease. According to FDA clinical data, the test catches only 55% to 65% of Stage I colorectal cancers [9]. A negative Shield result does not rule out cancer or precancer — the test's false-negative rate for CRC is 17%, meaning roughly 1 in 6 people with colorectal cancer will receive a clean result [10].

The 20 Million Unscreened Americans

The case for including blood tests in guidelines rests on a blunt reality: roughly one in three adults aged 45 to 75 are not up to date on colorectal cancer screening [11]. More than 20 million eligible Americans have never been screened at all [12]. Screening rates have improved — rising from 66.5% in 2014 to 72.5% in 2020 — but they remain below the national target of 80% set by the Colorectal Cancer Roundtable [13].

The barriers are well-documented: colonoscopy requires bowel preparation, sedation, and a day off work. Stool tests require handling fecal samples at home. For some patients, both options are nonstarters. Since the launch of the lab-developed version of Shield in May 2022, more than 90% of patients who were prescribed the test in a clinical setting completed it [4] — a completion rate that far exceeds the roughly 40% to 50% completion rate for FIT stool tests in some health systems [14].

"By offering more screening tools in our guideline update, more eligible adults will be able to participate in lifesaving colorectal cancer testing," said Dr. Robert Smith of the American Cancer Society [1].

The logic is that a less sensitive test done is better than a more sensitive test never taken. But that logic has limits.

The Follow-Through Problem

Blood tests detect cancer signals. They cannot remove polyps. Every positive Shield result requires a follow-up colonoscopy to confirm the finding and, if necessary, treat it. The ACS guideline specifies that this follow-up should occur within six months [1].

In practice, the completion rate falls well short. A UCLA Health study analyzing medical claims data from more than 6,000 individuals who received Shield tests between 2022 and 2024 found that only 49% of patients with abnormal results completed a follow-up colonoscopy within six months. Just 56% did so at any point during a two-year tracking period [15].

"Blood-based colorectal cancer screening is promising, but it only works if individuals complete the follow-up colonoscopy," said Dr. Folasade May, the study's senior author [15].

The problem is not unique to blood tests. Follow-up rates after positive stool tests are also poor: a JAMA Network Open study found that colonoscopy completion within one year of a positive FIT result was just 48.7% [14]. But blood test follow-up rates appear to be even lower, raising questions about whether adding a new front-end screening option will actually improve downstream outcomes. Research has shown that patients who receive a positive FIT result but do not complete a follow-up colonoscopy are twice as likely to die from colorectal cancer [16].

The Cost Equation

Shield's list price is $895 out of pocket, though Guardant Health set a cash pay rate of $1,495 effective August 2024 for uninsured patients [9][17]. That positions it between a FIT stool test (roughly $25) and a colonoscopy (averaging $1,000 to $3,000 depending on facility and findings) [18].

Source: ACS / CMS Data

Data as of May 27, 2026CSV

Under the Affordable Care Act, private insurers and Medicare are required to cover colorectal cancer screening tests recommended by the USPSTF with no out-of-pocket cost to patients [18]. Medicare Fee-for-Service already covers Shield at $0 out-of-pocket for eligible patients aged 45 to 85 [9]. Medicare Advantage patients may face co-pays depending on their plan [17].

A cost-effectiveness analysis published in Annals of Internal Medicine in October 2024, led by Stanford gastroenterologist Uri Ladabaum, found that colonoscopy remains the most cost-effective screening strategy. Blood tests offered to patients who refuse other screening methods produced the greatest gain in life-years compared to no screening — but the approach was not cost-effective in traditional health-economic terms [8][19].

The Cannibalization Concern

The loudest objections to guideline inclusion come from gastroenterologists who worry about substitution effects. The concern: if patients who currently get colonoscopies or stool tests switch to the less sensitive blood test, the net effect on population health will be negative.

The Stanford modeling study quantified this risk. Per 100,000 people screened over a lifetime, colonoscopy every 10 years would result in an estimated 1,543 cancer cases and 672 deaths. Stool-based tests every one to three years: 2,181 to 2,498 cases and 904 to 1,025 deaths. Blood tests every three years: 4,310 to 4,365 cases and 1,604 to 1,679 deaths. No screening at all: 7,470 cases and 3,624 deaths [8].

Blood-based screening, in other words, results in roughly 2.5 times more deaths than colonoscopy-based screening in the Stanford model.

"The blood tests are certainly much better than nothing, but you'll worsen the population outcomes" if patients abandon more effective methods, Ladabaum said [8].

The ACS guideline attempts to address this by designating blood tests as non-preferred and recommending them only for patients who decline other options [1]. Whether that distinction holds in clinical practice — where a simple blood draw may be easier for physicians to offer and patients to accept — remains to be seen.

Racial Disparities and the Equity Argument

One of the strongest arguments for blood-based screening is its potential to reduce racial disparities. Black Americans have a 20% higher incidence of colorectal cancer than other racial and ethnic groups and are 40% more likely to die from the disease [20]. Screening rates among Black adults have improved — rising from 68.0% in 2014 to 74.6% in 2020 — but structural barriers including socioeconomic inequality, medical mistrust, and lack of access to endoscopy facilities persist [13][20].

Proponents argue that a test requiring only a routine blood draw at a primary care visit could reach populations that colonoscopy infrastructure does not. A USC Schaeffer Center analysis suggested that blood-based multi-cancer detection tests could help mitigate disparities in early cancer diagnosis [21].

However, the published clinical data on Shield does not include subgroup analyses by race or ethnicity that would confirm whether sensitivity differs in Black Americans or other high-risk populations [5]. The UCLA follow-up study found that race and ethnicity were not significant predictors of follow-up colonoscopy completion after a positive blood test — a somewhat encouraging finding, though the study's authors noted the need for larger, more representative samples [15].

Who Profits

Guardant Health, based in Redwood City, California, is the sole holder of FDA approval for a blood-based colorectal cancer screening test. The company reported trailing 12-month revenue of $982 million as of December 31, 2025, and approximately 87,000 Shield screening tests were ordered in 2025 [22]. The company has expanded Shield distribution through partnerships with Quest Diagnostics and PathGroup [22].

The ECLIPSE trial that underpinned Shield's FDA approval and its inclusion in guidelines was sponsored by Guardant Health [4][5]. The study was published in the New England Journal of Medicine, which requires disclosure of industry funding. This is standard practice for diagnostic test validation — manufacturers typically fund the pivotal trials for their own products — but it means the primary evidence base for guideline inclusion was generated by the company that stands to benefit most from that inclusion.

Guardant has also enrolled patients in COSMOS, a larger registrational study intended to support broader Medicare reimbursement [22]. The company's Shield test was selected by the National Institutes of Health for inclusion in the Vanguard multi-cancer detection study [22].

The competitive landscape includes Exact Sciences, maker of the Cologuard stool DNA test, whose updated Cologuard Plus was also added to the ACS guidelines [1]. Abbott also highlighted its noninvasive screening products in response to the guideline update [23].

The Research Surge

Academic interest in liquid biopsy for colorectal cancer screening has grown rapidly. According to OpenAlex data, publications on the topic rose from 275 in 2011 to a peak of 3,572 in 2024, reflecting the intense research activity surrounding Shield's clinical trials and FDA review [24].

Source: OpenAlex

Data as of Jan 1, 2026CSV

Liability and the False-Negative Question

If a patient screens negative on Shield but develops colorectal cancer before the next recommended screening interval, who bears responsibility? The guideline and FDA labeling both include explicit warnings: "A negative result does not guarantee the absence of colorectal cancer or advanced adenoma" [10]. Patients are advised to continue screening at guideline-recommended intervals.

But the ACS guideline does not specify a distinct retesting cadence for Shield. The general recommendation for blood-based tests appears to be every three years, matching the interval for stool DNA tests [1]. By comparison, colonoscopy's screening interval is 10 years — a much longer window of protection enabled by its ability to detect and remove polyps before they become malignant.

The mismatch creates an ambiguity. A colonoscopy that finds no polyps provides substantial reassurance for a decade. A negative Shield result — which misses 87% of precancerous lesions — offers considerably less protection even over a three-year window [10]. No published legal precedents or guideline statements directly address clinician liability for interval cancers following a negative blood test, but the question looms as adoption scales.

The FDA fact sheet for Shield states that the test has "limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions" [10] — language that may become central to future informed-consent conversations and, potentially, malpractice claims.

What This Means for Patients

The ACS guideline update does not change the fundamental hierarchy of colorectal cancer screening. Colonoscopy remains the gold standard. Stool-based tests remain preferred noninvasive alternatives. The blood test is a third-line option — better than skipping screening entirely, but meaningfully less effective than the alternatives.

For the roughly 20 million Americans who have avoided screening altogether, a simple blood draw at an annual physical could be the difference between catching a cancer and missing one. For the millions already screening with colonoscopy or stool tests, switching to a blood test would be a step backward.

The ACS guideline's own framing captures the tension: "The most effective screening test is the one that the patient completes" [1]. That is true. But it is also true that the test a patient completes must be followed through to its conclusion — including the colonoscopy that a positive blood test demands. Until follow-up rates improve from their current 49% to 56% range, the promise of blood-based screening will remain partly theoretical [15].