Blood-based circulating tumour DNA (ctDNA) tests for colorectal cancer screening: Systematic review and meta-analysis of diagnostic accuracy.

For patients undergoing colorectal cancer screening with stool-based tests followed by a negative colonoscopy, management can be challenging due to potential concern for upper aerodigestive cancer or extra-colonic cancer. We sought to synthesize contemporary clinical approaches and cancer outcomes following a positive stool test and a negative colonoscopy and to identify areas in need of further research. Because of the heterogeneity of published research and available evidence, we conducted a scoping review of English-language, peer-reviewed, and full-text articles through September 2025. Two independent reviewers screened titles and abstracts followed by full text assessment, and data extraction. Data were synthesized thematically to explore the outcomes and work-up strategies associated with false-positive results in FIT and mt-sDNA tests within the context of extra-colonic cancer screening. Of 3442 studies identified, 49 underwent full text review of which 8 met inclusion criteria. Most patients were female and ≥50 years; however, reporting of demographic information was variable. The brand of stool-test, definition of stool-test positivity, definition of negative colonoscopy, and follow-up time were variably reported and defined. In terms of outcome, ~0.5% of patients had CRC on second colonoscopy. Incidence of non-colorectal aerodigestive or upper GI cancer ranged from 0-4.3%. There is a critical need for a standardized reporting framework among studies evaluating outcomes after positive stool-test and negative colonoscopy to better synthesize across studies and ultimately, improve clinical management.

ABSTRACT Background Late diagnosis of colorectal cancer (CRC) remains a public health challenge due to limitations in screening programs. This study evaluated the fecal immunochemical test (FIT) as an alternative screening method for CRC detection. Research design and methods Colonoscopy and immunochemical analysis were used as standard diagnostics. A population-based survey in Kazakhstan assessed disease prevalence and screening outcomes. Diagnostic accuracy and prognostic value of haemoccult testing were analyzed, comparing quantitative and qualitative results. Results Among 6,000 participants, 9.76% (n = 586) had positive FIT results. Elevated fecal hemoglobin concentrations (≥100 µg Hb/g stool) were found in 3.6% (n = 217), while 96.4% (n = 5786) had lower values. Of 150 clinically significant positive cases, 55 were confirmed, including 5 CRC cases and precancerous conditions. FIT facilitated large-scale screening. The Positive Predictive Value (PPV) for qualitative FIT was 10.4%, and for quantitative FIT (≥100 µg Hb/g), it was 15.7%. The Negative Predictive Value (NPV) for qualitative FIT was 100%, and for quantitative FIT, 99.5%. Conclusion FIT demonstrates practical value as an efficient screening tool for early CRC detection, with a weak but significant correlation to histological findings (p < 0.01).

Colorectal cancer (CRC) screening rates remain below recommended clinical guidelines, especially among people of color. This study aimed to assess CRC screening rates, identify barriers, and develop improvement strategies in racially diverse communities using community-based participatory design, engaging Community Health Action Teams (CHATs). This mixed-methods study employed surveys and focus groups, with data collection instruments co-designed with community members to ensure relevance and accuracy. A random sample of households with screen-eligible residents received a survey, focusing on assessing screening rates and identifying facilitators and barriers to CRC screening. Focus groups used snowball sampling in the same communities to deepen understanding through qualitative insights. Of 1,798 survey respondents, 81% reported participating in CRC screening, with 69% being up to date. Awareness of CRC's preventable and treatable nature, when detected early, (b = 0.647, p < 0.001, OR = 1.91); understanding its asymptomatic potential (b = 0.345, p < 0.001, OR = 1.42); and recognition of its ranking as the second most deadly cancer (b = 0.354, p = 0.007, OR = 1.42) were significant predictors of screening adherence. Knowledge of at-home tests increased compliance with screening (b = 0.752, p < 0.001, OR = 2.12). Barriers reported by unscreened respondents included a lack of symptoms (19%), absence of motivation (19%), being asymptomatic (20%), and for insured individuals, a lack of physician orders for screening (19%). Insights from focus groups, including 65 participants, revealed multi-level barriers, echoing survey findings where relationships with medical providers emerged as the strongest predictor of screening participation. The study informed the creation of six key outreach messages and two strategies co-led by CHATs, emphasizing CRC screening importance, test options, and cost considerations. Suggested strategies include organizing community events to raise awareness and enhancing direct provider-to-patient communication to encourage screening uptake.

Recently, stool- and blood-based cancer screening kits have been approved in clinical practice as convenient and noninvasive methods for colon cancer screening. One such test in long-standing practice has included the fecal immunochemical test (FIT), wherein home-based testing has rendered it a convenient initial assay to complement screening colonoscopy, despite limitations in diagnostic performance. In a recent original study published in the journal by Nguyen and colleagues, the feasibility and performance of combining FIT with circulating tumor cell (CTC) enumeration for predicting colorectal neoplasia and the risk of developing colorectal cancer were described. In this commentary, we highlight the potential of this combination as a novel colorectal cancer screening technique. The introduction of CTC as a potential colorectal cancer screening assay is timely, given the emergence of liquid biopsies that hold promise in their ability to detect a multitude of cancer-specific signals, from the detection of minimal residual disease to the detection of molecular alterations for precision therapies in oncology. We place the importance of their results in the context of the evolving landscape of stool- and blood-based colorectal cancer screening tests involving multitarget fecal DNA and cell-free DNA assays. See related article by Nguyen et al., Cancer Epidemiol Biomarkers Prev 2026;35:79-87.

Performance comparison of quantitative and qualitative fecal immunochemical tests in community-based colorectal cancer screening.

Early detection of gastrointestinal (GI) cancers remains a critical unmet clinical need, as most patients are diagnosed at advanced stages when prognosis is poor. Liquid biopsy has emerged as a transformative approach for minimally invasive cancer detection by analysing tumour-derived analytes in blood and other body fluids. Recent advances in circulating tumour DNA (ctDNA) sequencing, cell-free DNA methylation profiling, fragmentomics, extracellular vesicle and exosome characterisation, circulating tumour cell isolation and tumour-educated platelets have markedly improved sensitivity and specificity for detecting incipient malignancies. Despite these advances, sensitivity in stage I disease remains limited due to low tumour burden and minimal analyte scaling, resulting in false-negative results for small or indolent lesions. In addition, clonal haematopoiesis derived alterations can confound mutation-based assays, highlighting the need for epigenetic and multi-analyte approaches to improve specificity. Ultimately, widespread clinical adoption will require standardised, prospective trials demonstrating diagnostic accuracy and a reduction in cancer-specific mortality. Multi-analyte and machine learning-driven approaches, integrating DNA, RNA, protein and epigenomic signals, are now in late-stage clinical trials and poised for clinical translation. United States Food and Drug Administration approvals of blood-based colorectal cancer screening tests and laboratory-developed assays for hepatocellular carcinoma exemplify the translational momentum in this field. Here, we review the current landscape of liquid biopsy biomarkers for GI cancers, emphasising technological innovations, clinical performance and ongoing trials. We also discuss key challenges, including sensitivity in stage I disease, specificity amidst clonal haematopoiesis and integration with established screening paradigms. The continued evolution of assay technologies and translational research heralds a paradigm shift towards precision early detection of GI cancers, with the potential to substantially reduce mortality through earlier intervention. KEY POINTS: Liquid biopsy technologies are advancing rapidly for early detecion of GI cancers, using ctDNA, methylation profiling, fragmentomics, EVs, CTCs, and TEPs. Limited sensitivity in stage I disease remains a key barrier, largely due to low tumor burden and analyte scarcity. Clonal hematopoieses confounds mutation-based assays, emphasizing the need for epigenetic and multi-analyte strategies to improve specificity. Multi-analyte, machine-learning-driven platforms are nearing clinical translation, supported by late-stage trials and recent FDA approvals.

The recently published article from Rui and colleagues (1) describes a Markov modeling analysis of clinical and economic outcomes for three novel, noninvasive colorectal cancer screening tests [multitarget stool RNA (mt-sRNA), multitarget stool DNA 2.0 (mt-sDNA 2.0), and cell-free DNA (cf-DNA)], with comparisons to other guideline-recommended screening options or no screening. Per the authors, health economic evidence is critical for informing key decision-makers, including providers, payers, and policymakers (1). Although this is a worthy perspective, several issues related to the reported model inputs and resulting outcomes must be carefully considered to appropriately determine the relative contributions of this study.Most notably, many of the screening test–specific performance parameters listed in Table 1 (and elsewhere) of the Rui, et al. article appear to differ from the referenced data sources (1). For the mt-sDNA 2.0, mt-sRNA, and cf-DNA tests, many of the listed sensitivity values for advanced adenoma or nonadvanced adenoma are not readily identifiable in the cited studies (listed as references 9–11 in Rui, et al.; refs. 2–4). Although it is possible to derive some of these performance metrics from previously reported data, accurate calculations still yield different values from those shown in the table. Also, the modeled performance parameters are inconsistently defined across tests (i.e., sensitivity for all colorectal cancers vs. stages I–III only, advanced precancerous lesions vs. advanced adenomas), which creates non-parity and biases the resulting outcomes. For example, when specificity is defined as nonneoplastic or negative findings at colonoscopy, the value for mt-sDNA 2.0 does not change (92.7%), whereas the value for mt-sRNA decreases from 88.0% to 86.9% (2, 3).It is worth recognizing that for both the mt-sDNA 2.0 and mt-sRNA tests, modifications to the clinical validation study dataset were applied during the U.S. Food and Drug Administration (FDA) review process to better align the analysis cohort with the intended use population and to standardize the reported endpoint categories with other approved, noninvasive CRC screening tests. Based on the FDA approval datasets, colorectal sensitivity, advanced precancerous lesion sensitivity, and no colorectal neoplasia or negative colonoscopy specificity are 95.3%, 43.3%, and 92.7% for the mt-sDNA test and 92.6%, 41.3%, and 86.7% for the mt-sRNA test, respectively (5, 6). Applying these FDA-approved performance estimates, which best represent clinically expected performance characteristics for on-label screening, in the Markov modeling analyses would further challenge the results and conclusions reported by Rui and colleagues.With respect to the modeled screening strategy adherence assumptions, no peer-reviewed publications to date have reported completion rates for the mt-sRNA or cf-DNA tests in routine clinical practice (as the mt-sDNA and mt-sDNA 2.0 tests are provided and navigation-supported by the same company, it is reasonable to generalize adherence data for these tests). Therefore, any direct or implied reference to the adherence inputs for the mt-sRNA and cf-DNA tests as “real world” (i.e., see Abstract, Conclusions) is incorrect and misleading.Given that sensitivity and specificity inputs were identified as the most influential factors in the present study (1), colorectal cancer screening decision-makers would benefit from the authors’ correction and/or clarification of the modeling assumptions and associated outcomes so that the reported findings can be accurately interpreted and adjudicated with respect to potential practice, policy, and payer implications.P.J. Limburg reports other support from Exact Sciences outside the submitted work.

Comments were made by Limburg on the article by Rui and colleagues (1). This article is the first study to compare the cost-effectiveness of three novel colorectal cancer screening tests [multitarget stool RNA (mt-sRNA), multitarget stool DNA (mt-sDNA) 2.0, and cell-free DNA (cfDNA)] and all recommended screening strategies. The study concluded that all screening strategies were cost-effective compared with no screening. Every-10-year colonoscopy was the preferred cost-effective strategy under perfect adherence, whereas every-3-year mt-sRNA was the preferred option under test-specific adherence.In the process of conducting this study, the authors complied with guidelines of good research practices for modeling. Models synthesize evidence on health consequences and costs from multiple sources, such as clinical trials, observational studies, and peer-reviewed published findings (2, 3). Limburg’s comments referred to the study methodology. The authors, therefore, performed a self-assessment on the methodologic quality using the latest CHEERS checklist. The CHEERS checklist comprises 28 items across six categories: title, abstract, methods, results, discussion, and other relevant information (4). The quality assessment found that the published study fulfilled 25 of 28 items (89%) and is graded as excellent (scored ≥85%; ref. 5).Refer to comments on screening test-specific performance parameters; all parameters applied were sourced from peer-reviewed publications cited, either from the main text or supplementary materials of cited references. The parameters were defined consistently across tests. The details of data location in cited references and definitions applied are shown in Table 1.Model inputs in the present study were searched in PubMed, Embase, and Web of Science for peer-reviewed published literature. All base case values in health economic modeling are subject to uncertainties, and the uncertainties were examined by sensitivity analyses. Sensitivity analyses in the present study demonstrated that performance estimates of mt-sDNA 2.0 and mt-sRNA were influential factors in the cost-effectiveness results. The performance parameters in the FDA datasets are in line with estimates (referenced from published literature) used in the present study. If the FDA datasets were applied, it is also likely that the performance estimates would be influential factors.The term “real-world” adherence was applied to a nonperfect adherence scenario in the present study to evaluate the outcomes when adherence was <100% in all tests. The model inputs of adherence applied in the nonperfect adherence for mt-sDNA 2.0 and mt-sRNA were not yet reported and were therefore assumed to be the same as the marketed stool test mt-sDNA (with similar features), and the assumption was also examined by sensitivity analysis.No disclosures were reported.

Introduction Multi-target stool DNA (mt-sDNA) testing is a noninvasive colorectal cancer (CRC) screening test with higher sensitivity and real-world adherence than fecal immunochemical testing (FIT) or guaiac fecal occult blood testing (FOBT). However, data on adherence and follow-up colonoscopy (FU-CY) within individual health systems are limited. This study evaluated mt-sDNA adherence, FU-CY completion, and predictors within Massachusetts General Hospital (MGH). Methods We conducted a retrospective cohort study of 23,665 patients aged 45–75 years with mt-sDNA test orders in the MGH health system (June 2016–May 2023). Adherence was defined as return of a valid mt-sDNA kit. FU-CY was assessed within 12 months after a positive result. Multivariable logistic regression models identified patient- and provider-level predictors of adherence and FU-CY completion. Results Overall adherence to mt-sDNA screening was 78.4%, with a positivity rate of 10.5%. FU-CY completion within one year was 74.2%, with 91% completed within six months. Adherence was highest among adults aged 65–75 (80.1%), Asian or Pacific Islander patients (83.0%), Medicare beneficiaries (84.0%), rural residents (82.4%), and those with prior mt-sDNA testing (89.3%). Lower adherence was observed among Black (73.6%) and Hispanic (75.7%) patients, Medicaid beneficiaries (60.0%), and orders placed by nurse practitioners/physician assistants (71.7%). Multivariable analyses identified independent predictors of adherence and FU-CY completion, including race/ethnicity, payer type, income, provider specialty, geography, and patient return history. Age and sex were significant predictors of FU-CY completion. Conclusions Within a large health system, mt-sDNA screening demonstrated high overall adherence and timely FU-CY completion, exceeding those historically reported for FIT/FOBT.

The fecal immunochemical test (FIT) for detecting fecal occult blood, used alone or in combination with other stool biomarkers, has been demonstrated to be effective in the context of colorectal cancer (CRC) screening programs. However, FIT yields a significant proportion of false positives leading to unnecessary colonoscopies. In this study, we have investigated whether leftover FIT stool samples could be repurposed for proteomics analysis as a triage step for patients before recommending colonoscopy. High-throughput mass spectrometry analyses on a set of 141 FIT-positive samples (50 controls with no lesion, 45 with advanced adenomas and 46 with CRC) in combination with machine learning tools were used. Results showed that with a specificity ≥90%, a large proportion of the false FIT positives could be identified thus providing an efficient strategy for reducing unnecessary colonoscopies. Furthermore, CRC cases were also precisely predicted to be true positives, thus providing an approach for prioritizing patients for colonoscopy. In conclusion, this study demonstrates the feasibility of using proteomics for analysis of leftover FIT stool samples as an intermediate step to triage patients selected for colonoscopy in CRC screening programs.

BackgroundDespite the availability of multiple screening options, rates of colorectal cancer (CRC) screening remain suboptimal. With recent approval of a blood test for CRC screening, there is an urgent need to understand screening preferences of populations with low screening rates.MethodsBetween October 2023 and June 2024, we conducted a survey among adults aged 45–75 at ambulatory primary care clinics across multiple community health centers and federally qualified healthcare centers across the city as well as in community settings regardless of prior screeningResultsA total of 1,014 individuals completed the survey. Respondents were 12.8% Black/African American, 51.6% White, 23.4% Hispanic, 15.8% South Asian, and 4.2% Asian. Overall, the highest test preference was for screening colonoscopy (45.5%) followed by blood test (29.9%). Colonoscopy was preferred by individuals under age 70 (47.5%), while stool-based (20.2%) and blood-based (31.9%) tests were the most preferred among above 70 years (p = 0.0429. Whites (54.6%), Blacks (44.6%), and Hispanics (35.9%, p < 0.001) preferred colonoscopy, while Asians (37.2%) and South Asians (24.4%) favored blood tests. Factors associated with preference for a colonoscopy over other screening tests were younger age: respondents aged below 70 years were more likely to prefer colonoscopy, compared to respondents aged above 70 years (OR = 1.72, 95% CI [1.20–2.47], p = 0.003); Nonsmoker compared to former/current smokers (OR = 2.04, 95% CI: [1.10–3.94], p = 0.028); Having undergone a prior colonoscopy (OR = 6.83, 95% CI: [4.52–10.6], p = < 0.001) or not having a prior stool test (OR = 1.56, 95% CI: [1.52–2.11], p = < 0.001). Factors associated with preference for a blood test over other screening tests were education level: respondents without any college experience were more likely to prefer blood test compared to respondents with college experience (OR = 1.46, 95% CI: 1.02–2.07, p = 0.038); Nonsmoker compared to former/current smokers (OR = 1.73, 95% CI: [1.00–2.99], p = 0.048); Never undergone a prior colonoscopy (OR = 1.76, 95% CI: [1.23–2.51], p = 0.002). Factors associated with preference for a stool test over other screening tests were: age over 80 years compared to respondents aged below 80 (OR = 3.34, 95% CI: 1.67–6.55, p < 0.001); respondents with college experience were more likely to prefer blood test compared to respondents without college experience (OR = 1.62, 95% CI: 1.02–2.66, p = 0.048);ConclusionThe study underscores importance of patient preference in deciding which tests to offer. Tailored strategies addressing demographic, socioeconomic, and health belief barriers are needed to improve CRC screening adherence.

Noninvasive tests for colorectal cancer (CRC) screening in average-risk individuals continue to evolve, with the premise of increasing screening participation among eligible individuals. In addition to fecal immunochemical testing (FIT), which has become the noninvasive standard for which to improve sensitivity for detecting CRC and specificity for detecting the absence of CRC, new US Food and Drug Administration-approved tests include the detection of DNA in a next-generation multitarget stool DNA test, the detection of RNA in a multitarget stool RNA test, and blood tests that detect cell-free DNA for genomic alterations, fragmentations, and aberrant methylation, all of which have undergone large clinical trials for effectiveness. Each of these new tests improves upon the CRC sensitivity of FIT but not its specificity. Test sensitivity for CRC detection in persons <50 years of age is comparable to that in persons >50 years. Fecal tests with direct sampling of stool have improved sensitivity for advanced adenomas compared to FIT, but advanced adenoma sensitivity is regressed in blood tests compared to FIT. With about a third of the screening-eligible population not actively screened in the United States, the expansion of the screening-eligible population to include those >45 years of age, the disparity in some populations with lower-than-average screening rates, and the limited colonoscopy screening opportunities due to choice, schedule, availability, or pandemic interruption, these noninvasive tests may fill the gap and rectify CRC screening shortcomings and barriers that colonoscopy alone cannot fill.

Centers for Medicare and Medicaid and colorectal cancer screening test standards: time for a change.

Most colorectal cancer (CRC) screening tests, including fecal immunochemical (FIT) and multitarget stool DNA tests, require patients to scrape a stool sample at home before mailing it to a central lab. This requirement not only deters screening adherence but can also introduce risks of human error, environmental exposure, and transit-related issues. The multitarget stool RNA test (mt-sRNA), which comprises a FIT component and an RNA molecular component, is the only FDA-approved stool-based test for the detection of both CRC and advanced adenomas (AA) that does not require patients to perform an at-home FIT. Instead, trained technicians complete the FIT in the laboratory after the sample is received. This study evaluates the comparability of at-home and in-laboratory FIT in relation to mt-sRNA test performance. To assess comparability between the 2 FIT methods, banked residual stool samples from the mt-sRNA test pivotal clinical trial (CRC-PREVENT) were used. As part of clinical trial requirements, subjects were required to collect a stool sample using the mt-sRNA collection kit and complete an at-home FIT swab before shipping the sample back to the laboratory. Patients were subsequently required to complete a screening colonoscopy. Residual stool was sampled using the in-laboratory FIT. Both FIT collection methods (at-home and in-laboratory) were analyzed identically. FIT results were compared with each other and with colonoscopy, to assess concordance, sensitivity, and specificity. A total of 1079 stool samples were tested using both at-home and in-laboratory FIT methods. Overall concordance was 93%. Among 20 CRC cases, the sensitivity for both methods was 75% (n=15). For 231 AA cases, sensitivity for the at-home and in-laboratory FIT was 33% and 38%, respectively. Positive percent agreement (PPA) for colorectal neoplasia was 87%. Among 791 subjects with negative findings, specificity for the at-home and in-laboratory FIT was 94% and 95%, respectively. For subjects with negative findings, the negative percent agreement (NPA) was 98%. When incorporating the in-laboratory FIT into the mt-sRNA test, method-calibrated CRC and AA sensitivities were 94% and 48%, respectively. Method-calibrated specificity for no lesions on colonoscopy was 90%. Our findings suggest that in-laboratory FIT performance may enhance the diagnostic accuracy of the mt-sRNA test. The in-laboratory method may also reduce inadequate sampling and improve patient ease of use.

22 Background: Blood testing for CRC screening is a non-invasive option that could improve suboptimal adherence. One such test, SimpleScreen CRC, detects base-level methylation patterns in cell-free DNA (cfDNA) isolated from plasma, using an artificial intelligence/machine learning-enabled classification model. Its clinical performance was recently validated in a pivotal study of 27,010 individuals at average risk for CRC (PREEMPT CRC). Since then, we improved the assay’s signal-to-noise ratio by optimizing key aspects of our methylated cfDNA detection platform, more than doubling molecular signal. We compared performance between the improved and previous assay versions in a case-control validation study, applying the locked SimpleScreen CRC classification model to paired data from independent clinical samples. We also projected the change in lifetime CRC incidence, CRC mortality, and life-years gained (LYG) in a validated microsimulation model. Methods: Clinical test performance was assessed using both versions in an average-risk cohort (N = 965; 210 CRC, 407 advanced precancerous lesions [APL; 329 were collected pre-colonoscopy], 144 non-APL, and 204 negative). Specificity was set to 90% for each version to enable direct comparison. Sensitivity was calculated nominally and, to reflect the intended-use population (IUP), adjusted for age and sex using distributions from the US Census, and for CRC stage, APL subtype, and lesion size using distributions from PREEMPT CRC. Two-sided confidence intervals (CIs) were calculated using Wilson’s method. Clinical blends and contrived samples, respectively, were used to determine limit of detection (LoD; n = 90) and limit of blank (LoB; n = 92). Modeled outcomes were assessed per 1000 people for a cohort screened from ages 45 to 75 y (COSMOS CRC). Results: The improved test showed an IUP-adjusted CRC and APL sensitivity of 85.2% (95% CI: 78.5 - 90.1%) and 21.7% (17.1 - 27.2%), respectively, at 90% IUP-adjusted specificity, 1.7 points (-2.8 to +6.2) and 5.4 points (-0.2 to +10.9) higher than the previous version (CRC: 83.5% [76.6 - 88.7%]; APL: 16.3% [12.3 - 21.4%]). Nominal CRC sensitivity was 88.6% for the improved test vs 86.5%, and APL sensitivity was 27.0% vs 22.3%, respectively, at 90% specificity. Stage I, II and III CRC sensitivities were higher for the improved test, while both versions achieved 100% sensitivity in stage IV. The improved test had a 2.6-fold lower LoD and 2.5-fold lower LoB. Improvements were predicted to reduce lifetime CRC cases by 9% (39.0 vs 42.9) and CRC deaths by 10% (12.5 vs 13.9), and improve LYG by 7% (246 vs 229) compared with the previous version. Conclusions: Assay improvements to a CRC screening blood test resulted in higher CRC and APL sensitivity, and better predicted patient outcomes. The improved test will continue to be evaluated, and associated data will be submitted to the Food and Drug Administration after the approval of SimpleScreen CRC.

The performance of a CRC screening blood test was validated in a prospective, multicenter, observational study (PREEMPT CRC). The composition of the clinical study population can impact performance measures, potentially affecting the generalizability of the observed outcomes. We conducted a prespecified post-stratification adjustment analysis in which PREEMPT CRC performance values were adjusted to US Census age and sex distribution. The PREEMPT CRC evaluable cohort had a higher proportion of younger individuals and females than the census population. Compared to observed values, census adjustment demonstrated nominally higher CRC sensitivity (81.1% [95% confidence interval or CI, 71.3-88.1%] vs 79.2% [95% CI, 68.4-86.9%]) and advanced precancerous lesion sensitivity (13.7% [95% CI, 12.4-15.0%] vs 12.5% [95% CI, 11.3-13.8%]), with lower advanced colorectal neoplasia specificity (90.4% [95% CI, 90.0-90.7%) vs 91.5% [95% CI, 91.2-91.9%]). Negative and positive predictive values were consistent across age groups, highlighting consistent clinical interpretability of test results regardless of patient age.

Factors related to the intention to perform a fecal occult blood test for colorectal cancer screening, based on the Health Belief Model and health literacy: A cross-sectional study.

Noninvasive colorectal cancer (CRC) screening bears high potential for increasing participation if implemented in a straightforward way. We have evaluated the feasibility and diagnostic performance of a smartphone-based fecal immunochemical test (FIT) for CRC screening and compared its performance with a laboratory-based FIT. Individuals scheduled for a screening colonoscopy in gastroenterology practices in Southern Germany enrolled into the BLITZ study between 2021 and 2023 were offered a smartphone-based FIT and a laboratory FIT. The smartphone-based FIT consists of a rapid test and a smartphone app. The app quantitatively evaluates the result of the rapid test using the smartphone camera. The feasibility of the smartphone-based FIT was evaluated in a self-administered questionnaire. The comparative performance of the 2 FITs was evaluated by sensitivity, specificity, and receiver-operator curve (ROC) measures. Of 654 study participants who were offered both a smartphone-based FIT in addition to the laboratory FIT, 361 (55%) made use of the smartphone-based FIT, 274 (76%) of those had a valid smartphone-based FIT, and 643 (98%) used the laboratory FIT. Overall, 89% considered the smartphone-based FIT as a useful alternative offer to the laboratory FIT. The reasons why the smartphone-based FIT was not used were mostly technical (app- or smartphone-related, 47%) or reflecting more general concerns or attitudes towards such a test (44%). The smartphone-based FIT showed a sensitivity for advanced neoplasms (28%; 95% confidence interval [CI], 13%-47%) similar to the laboratory FIT (34%; 95% CI, 18%-54%) at an identical specificity (92%; 95% CI, 87%-95%). The smartphone-based FIT could serve as an alternative in addition to currently offered laboratory FITs. German Clinical Trials Register (drks.de), Number: DRKS00008737.

Optimizing Colonoscopy Capacity to Maximize Colorectal Cancer Outcomes.