Multitarget Stool DNA Test Research Articles

S302 Multitarget Stool DNA Testing Has a High Positive Predictive Value for Colorectal Neoplasia on the Second Round of Testing

S302 Multitarget Stool DNA Testing Has a High Positive Predictive Value for Colorectal Neoplasia on the Second Round of Testing

Utilization of a Colorectal Cancer Screening Test Among Individuals With Average Risk

Colorectal cancer (CRC) screening reduces CRC incidence and mortality. It is important to examine screening patterns over time, including after the introduction of new screening modalities. To compare use of CRC screening tests before and after the availability of the multitarget stool DNA (mt-sDNA) test, given that endorsed options have changed. This longitudinal cohort study used administrative claims data to examine CRC screening use in 2 discrete periods: before (August 1, 2011, to July 31, 2014) and after (August 1, 2016, to July 31, 2019) the mt-sDNA test became available. The MarketScan Commercial and Medicare Supplemental databases were queried for individuals aged 45 to 75 years between August 1, 2011, and July 31, 2019, with average risk of CRC and with continuous enrollment in the databases from August 1, 2001, to July 31, 2019. The proportion of individuals up to date or not due for CRC screening during each measurement year and the type of screening test used among individuals due for screening. Data were reported overall and among individuals aged 45 to 49 or 50 years and older on August 1, 2011. A total of 97 776 individuals with average risk were identified. Individuals had a mean (SD) age of 50.8 (3.5) years, and 54 227 (55.5%) were women. The proportion of individuals with average risk aged 50 to 75 years with commercial or Medicare supplemental insurance who were up to date with CRC screening increased from 50.4% in 2011 (30 605 of 60 770) to 69.7% in 2019 (42 367 of 60 770). Among individuals due for screening and screened, the use of high-sensitivity fecal occult blood test (FOBT) decreased between 2011 (1088 of 6241 eligible individuals [17.7%]) and 2019 (195 of 2943 eligible individuals [6.6%]), and the use of mt-sDNA increased between 2016 (58 of 3014 eligible individuals [1.9%]) and 2019 (418 of 2943 eligible individuals [14.2%]). No consistent trends were observed with fecal immunochemical test (FIT) or screening colonoscopy. Computed tomography colonography, double-contrast barium enema, and flexible sigmoidoscopy were rarely performed. In this cohort study, the proportion of individuals with average risk who were up to date with CRC screening increased between 2011 and 2019 but remained suboptimal. There were no substantial changes in the use of the colonoscopy or FIT; however, there was an increase in the adoption of mt-sDNA and a decrease in the use of FOBT during the study period.

Rising Use of Multitarget Stool DNA Testing for Colorectal Cancer

Deborah A. Fisher, MD; Nicole Princic, MS; Lesley-Ann Miller-Wilson, PhD; Kathleen Wilson, MPH; A. Mark Fendrick, MD; Paul Limburg, MD

PPV and Detection Rate of mt-sDNA Testing, FIT, and CT Colonography for Advanced Neoplasia: A Hierarchic Bayesian Meta-Analysis of the Noninvasive Colorectal Screening Tests.

BACKGROUND. Noninvasive tests for colorectal cancer (CRC) screening and prevention limit the need for invasive colonoscopy to follow up positive test results. However, the relative performance characteristics of available noninvasive tests have not yet been adequately compared. OBJECTIVE. We performed a systematic review and meta-analysis to compare the diagnostic performance of the available noninvasive CRC screening tests, including multitarget stool DNA (mt-sDNA) testing, fecal immunochemical testing (FIT), and CT colonography (CTC), with an emphasis on comparison of PPV and detection rate (DR) for advanced neoplasia (AN; encompassing cases of advanced adenomas and CRC). EVIDENCE ACQUISITION. After systematic searches of MEDLINE and Google Scholar databases, 10 mt-sDNA, 27 CTC, and 88 FIT published screening studies involving 25,132, 33,493, and 2,355,958 asymptomatic adults, respectively, were included. Meta-analysis with hierarchic Bayesian modeling was conducted in accordance with Cochrane Collaboration and PRISMA guidelines to determine test positivity rates (TPRs) leading to optical colonoscopy, as well as PPVs and DRs for both AN and CRC. Different positivity thresholds were considered for FIT and CTC. EVIDENCE SYNTHESIS. Point estimates (with 95% credible intervals) from pooled Bayesian meta-analysis combining all thresholds for FIT and stratifying CTC results by a polyp size threshold of 6 mm or larger (CTC6) and 10 mm or larger (CTC10) were calculated. TPR was 13.5% (10.9-16.6%) for mt-sDNA testing, 6.4% (5.8-7.2%) for FIT, 13.4% (11.4-15.6%) for CTC6, and 6.6% (5.2-7.7%) for CTC10. AN PPV was 26.9% (95% credible interval, 21.8-33.2%) for mt-sDNA testing, 31.8% (29.3-34.5%) for FIT, 34.4% (27.2-41.0%) for CTC6, and 61.0% (54.0-70.0%) for CTC10. CRC PPV was 2.4% (1.5-3.9%) for mt-sDNA testing, 4.9% (4.3-5.3%) for FIT, 3.5% (2.5-4.8%) for CTC6, and 6.0% (4.3-8.0%) for CTC10. The DR for AN was 3.4% (95% credible interval, 2.5-4.8%) for mt-SDNA, 2.0% (1.8-2.3%) for FIT, 4.8% (4.0-6.5%) for CTC6, and 4.0% (3.0-4.6%) for CTC10. When FIT is restricted to a lower threshold (< 10 μg Hb/g feces), its performance profile is similar to that of mt-sDNA testing, although available data are limited. AN PPV odds ratios (relative to CTC10 as the reference) were 0.24 (95% credible interval, 0.17-0.33) for mt-sDNA testing, 0.30 (0.24-0.45) for FIT, and 0.33 (0.25-0.47) for CTC6. CONCLUSION. Among noninvasive CRC screening tests, CTC with a polyp size threshold of 10 mm or larger most effectively targets AN, preserving detection while also decreasing unnecessary colonoscopies compared with mt-sDNA testing and FIT. CLINICAL IMPACT. CTC performed with a polyp size threshold for colonoscopy referral set at 10 mm or larger represents the most effective and efficient noninvasive screening test for CRC prevention and detection.

Retrospective Review of Multitarget Stool DNA as a Screening Test for Colorectal Cancer.

To review the effectiveness of noninvasive multitarget stool DNA testing as a screening test for colorectal cancer. We performed a retrospective review of patients referred to 2 high volume outpatient procedural centers for colonoscopy for positive Cologuard test. Positive findings for colorectal cancer based on pathologic findings and also advanced adenomas were recorded. Positive predictive value (PPV) was assessed. Of the 1585 patients evaluated and referred for colonoscopy from January 1, 2018 to November 1, 2019, for ICD-10 codes R19.5 (other fecal abnormalities) and K92.1 (melena), 84 were referred for a positive Cologuard test. Out of the 84, 6 were excluded based on family history of colon cancer in first degree relative or personal history of inflammatory bowel disease. Of the remaining 78 patients, 1 patient (1.3%) had colorectal cancer and 5 (6.4%) had advanced adenomas (>1cm size, high grade dysplasia or villous). Postive predictive value for colorectal cancer was 1.3% and for precancerous lesions plus colorectal cancer was 7.7%. A total of 53 (68.0%) patients had either totally normal colonoscopy or hyperplastic polyps. Out of the 78 individuals in our study, 70 (89.7%) had normal findings, hyperplastic polyps, or non-advanced adenomas. Multitarget stool DNA testing carries an unacceptably low PPV to be utilized as a screening test for colorectal cancer. The study fails to detect both adenomas and colon cancer at a higher rate than screening colonoscopy in selected studies. The advantage of being noninvasive has been noted to increase colorectal cancer screening in otherwise non-compliant Medicare patients.

PMD22 Cross-Sectional Adherence with the Multi-Target Stool DNA Test for Colorectal Cancer Screening in a Medicaid Population

Colorectal cancer (CRC) is the second most deadly cancer in the US. Early detection improves CRC outcomes. Multiple options are endorsed for CRC screening; however, adherence remains a challenge and underutilization of CRC screening has been documented among Medicaid enrollees (between 12.3–21.3% in some studies). The multi-target stool DNA (mt-sDNA) test, which includes patient and provider navigation support, may afford greater adherence to CRC screening in this population. We assessed cross-sectional adherence with mt-sDNA in a sample of patients with Medicaid.

Colorectal cancer screening and prevention: A brief review of the current guidelines and modalities

Colorectal cancer (CRC) remains a frequently addressed topic in primary care. Recent studies have been published detailing modifiable risk factors for CRC, as well as preventative measures. Providers must be up to date on screening recommendations and modalities. Colonoscopy is the preferred method of screening for CRC, and the screening recommendations in the United States were recently updated in 2020. It is also common for the practitioner to encounter patients who refuse colonoscopy but are willing to undergo alternative methods of testing. The COVID pandemic has also placed a burden on hospital resources, and colonoscopy may not be logistically feasible in some healthcare settings. Therefore, awareness of the guidelines for the various alternative modalities, along with their respective guidelines for frequency of screening is critical. This article provides a brief review of the risk factors associated with colon cancer, the screening modalities (including colonoscopy, sigmoidoscopy, CT colonography, fecal immunohistochemical testing (FIT), guaiac-based fecal occult blood testing (gFOBT), multi target stool DNA testing (MTs-DNA), and others) and the most recent screening recommendations for the general population.

ID: 3527212 A RETROSPECTIVE COHORT STUDY OF PATIENTS WITH POSITIVE COLOGUARD RESULTS AT A RURAL TERTIARY COMMUNITY HOSPITAL

Since receiving FDA approval in 2014, the use of multitarget stool DNA testing (MT-sDNA or Cologuard) testing has become a reputable option for colorectal cancer (CRC) screening amongst appropriate patient populations. The high sensitivity provided by Cologuard promises providers a powerful screening tool for colorectal cancer. The original study evaluating the statistical parameters of Cologuard, should represent a general patient population. However, given the controlled nature of clinical trials, further evaluation in real-life clinical practice was needed.

Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening in a large, nationally insured cohort

PurposeColorectal cancer (CRC) is the second most deadly cancer in the USA. Early detection can improve CRC outcomes, but recent national screening rates (62%) remain below the 80% goal set by the National Colorectal Cancer Roundtable. Multiple options are endorsed for average-risk CRC screening, including the multi-target stool DNA (mt-sDNA) test. We evaluated cross-sectional mt-sDNA test completion in a population of commercially and Medicare-insured patients.MethodsParticipants included individuals ages 50 years and older with commercial insurance or Medicare, with a valid mt-sDNA test shipped by Exact Sciences Laboratories LLC between January 1, 2018, and December 31, 2018 (n = 1,420,460). In 2020, we analyzed cross-sectional adherence, as the percent of successfully completed tests within 365 days of shipment date.ResultsOverall cross-sectional adherence was 66.8%. Adherence was 72.1% in participants with Traditional Medicare, 69.1% in participants with Medicare Advantage, and 61.9% in participants with commercial insurance. Adherence increased with age: 60.8% for ages 50–64, 71.3% for ages 65–75, and 74.7% for ages 76 + years. Participants with mt-sDNA tests ordered by gastroenterologists had a higher adherence rate (78.3%) than those with orders by primary care clinicians (67.2%). Geographically, adherence rates were highest among highly rural patients (70.8%) and ordering providers in the Pacific region (71.4%).ConclusionsData from this large, national sample of insured patients demonstrate high cross-sectional adherence with the mt-sDNA test, supporting its role as an accepted, noninvasive option for average-risk CRC screening. Attributes of mt-sDNA screening, including home-based convenience and accompanying navigation support, likely contributed to high completion rates.

Impact of the sessile serrated polyp pathway on predicted colorectal cancer outcomes in the CRC-AIM model.

10545 Background: Approximately 20–30% of colorectal cancers (CRC) arise from the serrated polyp pathway. The multitarget stool DNA (mt-sDNA) test has greater sensitivity to detect sessile serrated polyps (SSPs) than a leading fecal immunochemical test (FIT). However, most modeling analyses do not account for the contribution of the SSP pathway to risk of CRC. We used the CRC-AIM model to assess the impact of the SSP pathway on predicted CRC outcomes with mt-sDNA or FIT screening. Methods: A simulated cohort of average-risk US patients underwent triennial mt-sDNA or annual FIT screening from ages 50–75. The percentage of CRCs arising from the SSP pathway were modeled at 0% (base case), 20%, and 30%, with stool screening adherence based on theoretical (100%) or previously reported (mt-sDNA 71%; FIT 43%) rates. Published SSP sensitivities for mt-sDNA and FIT were used. All other model inputs were identical to CISNET models. Sensitivity analyses used screening adherence rates of 40–70%. Key outcomes were life-years gained (LYG), CRC incidence and CRC mortality per 1000 patients. Results: Including SSPs in the model demonstrated a greater loss of LYG with FIT than mt-sDNA (Table). At 100% adherence, compared with base case, modeling 20% or 30% SSP pathway CRCs resulted in a decrease of 9–15 LYG with FIT and 2–4 LYG with mt-sDNA, a decrease in CRC incidence reduction of 3.9–6.1% with FIT and 0.7–1.1% with mt-sDNA, and a decrease in CRC mortality reduction of 2.6–4.0% with FIT and 0.4–0.8% with mt-sDNA. Using previously reported adherence, compared with base case, modeling 20% or 30% SSP pathway CRCs resulted in a decrease of 13–20 LYG with FIT and 2–5 LYG with mt-sDNA, a decrease in CRC incidence reduction of 4.4–6.9% with FIT and 0.6–1.1% with mt-sDNA, and a decrease in CRC mortality reduction of 3.5–5.4% with FIT and 0.4–0.9% with mt-sDNA. Assuming reported adherence and 30% SSP pathway CRCs, mt-sDNA had 48 more LYG, 14.6% greater CRC incidence reduction, and 12.4% greater CRC mortality reduction than FIT. Assuming 30% SSP pathway CRCs, outcomes favored mt-sDNA vs FIT even after modeling equivalent adherence rates ranging from 40–70%. Conclusions: After incorporating the SSP pathway into the model, outcomes with mt-sDNA neared those of FIT at 100% screening adherence rates and surpassed FIT at more realistic reported screening adherence rates.[Table: see text]

Disparities Among Limited English Proficient Patients in Colon Cancer Screening with Multi-target DNA Stool Test.

Racial and language minority groups in the U.S. are at a higher risk for morbidity and mortality from colorectal cancer (CRC), partially due to lower screening rates. This is a retrospective cohort study comparing successful multi-target stool DNA test (mt-sDNA) test completion among patients with limited English proficiency (LEP) and English proficient (EP) patients, from 2015 to 2018. Patients with LEP were frequency matched to EP patients by age at a 3:1 ratio. The percentage of mt-sDNA tests without useful results was 53% among patients with LEP compared to 29% among EP patients (p < 0.0001). The median number of days from order placement to test completion was 62.5 among patients with LEP compared to 33 for EP patients (p = 0.003). This study demonstrates a significant disparity in CRC screening completion using the mt-sDNA test among populations with LEP, which may widen existing disparities in CRC mortality.

Colorectal Neoplasia Detection in Individuals With Positive Multitarget Stool DNA Tests: Data From the New Hampshire Colonoscopy Registry.

The US Preventive Services Task Force (USPSTF) includes multitarget stool DNA (mt-sDNA) testing as a colorectal cancer (CRC) screening option in average-risk individuals, but data on colonoscopy outcomes after positive mt-sDNA tests in community settings are needed. The aim of this study was to investigate colonoscopy outcomes and quality following positive mt-sDNA in the population-based New Hampshire Colonoscopy Registry. We compared colonoscopy outcomes and quality between age-matched, sex-matched, and risk-matched patients from 30 endoscopy practices with and without a preceding positive mt-sDNA test. Main outcomes were colonoscopy findings of CRC, advanced noncancerous neoplasia, nonadvanced neoplasia, or normal examination. Quality measures included withdrawal time, bowel preparation quality, examination completion, and percentage of average-risk individuals with normal colonoscopies receiving a USPSTF-recommended 10 year rescreening interval. Individuals with positive mt-sDNA tests (N=306, average age 67.0 y; 61.8% female) were significantly more likely than colonoscopy-only patients (N=918, 66.2 y; 61.8% female) to have CRC (1.3% vs. 0.4%) or advanced noncancerous neoplasia (27.1% vs. 8.2%) (P<0.0001). Neoplasia was found in 68.0% of patients having colonoscopy after a positive mt-sDNA test, (positive predictive value, was 68.0%), versus 42.3% of patients with colonoscopy only (P<0.0001). No significant differences in colonoscopy quality measures were observed between cohorts. Colonoscopy after a positive mt-sDNA test was more frequently associated with CRC and colorectal neoplasia than colonoscopy alone. Positive mt-sDNA tests can enrich the proportion of colonoscopies with clinically relevant findings. Follow-up recommendations suggest that endoscopists do not inappropriately shorten rescreening intervals in mt-sDNA-positive patients with normal colonoscopy. These findings support the clinical utility of mt-sDNA for CRC screening in community practice.

Multitarget stool DNA test cost effective for CRC screening in Alaska

Multitarget stool DNA test cost effective for CRC screening in Alaska

National Survey of Patient Factors Associated with Colorectal Cancer Screening Preferences

Recommended colorectal cancer screening modalities vary with respect to safety, efficacy, and cost. Better understanding of the factors that influence patient preference is, therefore, critical for improving population adherence to colorectal cancer screening. To address this knowledge gap, we conducted a panel survey focused on three commonly utilized colorectal cancer screening options [fecal immunochemical test or guaiac-based fecal occult blood test (FIT/gFOBT), multi-target stool DNA (mt-sDNA) test, and colonoscopy] with a national sample of U.S. adults, ages 40-75 years and at average risk of colorectal cancer, in November 2019. Of 5,097 panelists invited to participate, 1,595 completed the survey (completion rate, 31.3%). Our results showed that when presented a choice between two colorectal cancer screening modalities, more respondents preferred mt-sDNA (65.4%) over colonoscopy, FIT/gFOBT (61%) over colonoscopy, and mt-sDNA (66.9%) over FIT/gFOBT. Certain demographic characteristics and awareness of and/or experience with various screening modalities influenced preferences. For example, uninsured people were more likely to prefer stool-based tests over colonoscopy [OR, 2.53; 95% confidence interval (CI), 1.22-5.65 and OR, 2.73; 95% CI, 1.13-7.47]. People who had heard of stool-based screening were more likely to prefer mt-sDNA over FIT/gFOBT (OR, 2.07; 95% CI, 1.26-3.40). People who previously had a stool-based test were more likely to prefer FIT/gFOBT over colonoscopy (OR, 2.75; 95% CI, 1.74-4.41), while people who previously had a colonoscopy were less likely to prefer mt-sDNA or FIT/gFOBT over colonoscopy (OR, 0.39; 95% CI, 0.24-0.63 and OR, 0.40; 95% CI, 0.26-0.62). Our survey demonstrated broad patient preference for stool-based tests over colonoscopy, contrasting the heavy reliance on colonoscopy for colorectal cancer screening in clinical practice and highlighting the importance of considering patient preference in colorectal cancer screening recommendations. PREVENTION RELEVANCE: Our national survey demonstrated broad patient preference for stool-based tests over colonoscopy, contrasting the heavy reliance on colonoscopy for colorectal cancer screening in clinical practice and highlighting the importance of considering patient preference in colorectal screening recommendations.

Cost-Effectiveness of Multitarget Stool DNA Testing vs Colonoscopy or Fecal Immunochemical Testing for Colorectal Cancer Screening in Alaska Native People

ObjectiveTo estimate the cost-effectiveness of multitarget stool DNA testing (MT-sDNA) compared with colonoscopy and fecal immunochemical testing (FIT) for Alaska Native adults. Patients and MethodsA Markov model was used to evaluate the 3 screening test effects over 40 years. Outcomes included colorectal cancer (CRC) incidence and mortality, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). The study incorporated updated evidence on screening test performance and adherence and was conducted from December 15, 2016, through November 6, 2019. ResultsWith perfect adherence, CRC incidence was reduced by 52% (95% CI, 46% to 56%) using colonoscopy, 61% (95% CI, 57% to 64%) using annual FIT, and 66% (95% CI, 63% to 68%) using MT-sDNA. Compared with no screening, perfect adherence screening extends life by 0.15, 0.17, and 0.19 QALYs per person with colonoscopy, FIT, and MT-sDNA, respectively. Colonoscopy is the most expensive strategy: approximately $110 million more than MT-sDNA and $127 million more than FIT. With imperfect adherence (best case), MT-sDNA resulted in 0.12 QALYs per person vs 0.05 and 0.06 QALYs per person by FIT and colonoscopy, respectively. Probabilistic sensitivity analyses supported the base-case analysis. Under varied adherence scenarios, MT-sDNA either dominates or is cost-effective (ICERs, $1740-$75,868 per QALY saved) compared with FIT and colonoscopy. ConclusionEach strategy reduced costs and increased QALYs compared with no screening. Screening by MT-sDNA results in the largest QALY savings. In Markov model analysis, screening by MT-sDNA in the Alaska Native population was cost-effective compared with screening by colonoscopy and FIT for a wide range of adherence scenarios.

Off-Label Use of Multitarget Stool DNA Testing in Primary Care.

We evaluated the off-label use of multitarget stool DNA (mt-sDNA) testing in the primary care setting. We reviewed all mt-sDNA orders between July 1, 2018, and June 30, 2019, to determine the frequency of off-label mt-sDNA orders. Nine hundred two patients with mt-sDNA orders were evaluated, of which 160/902 patients (17.7%) met at least 1 criterion for off-label mt-sDNA order. Increasing age was associated with off-label order (Odds Ratio [OR] 2.32 [95% CI, 1.86-2.89] for every 10-year increase in age, P < 0.0001). On multivariate analysis, increased age (OR 1.04 [1.02-1.06], P = 0.001) and need for diagnostic colonoscopy (OR 2.9 [1.01-8.34], P = 0.048) were associated with a positive mt-sDNA result. Off-label mt-sDNA testing is common, and further efforts are needed to educate patients and providers on appropriate use of mt-sDNA for colorectal cancer screening.

Cross-sectional adherence with the multitarget stool DNA test for colorectal cancer screening in a large, national study of insured patients.

27 Background: Colorectal cancer (CRC) is the second most deadly and fourth most frequently diagnosed cancer in the United States. Early detection can improve CRC outcomes, but overall screening rates (62%) remain below the 80% goal set by the National Colorectal Cancer Roundtable. Multiple options are endorsed for average-risk CRC screening, including the multi-target stool DNA (mt-sDNA) test, which includes patient and provider navigation support. Cross-sectional adherence with the mt-sDNA test was previously reported in a large Medicare population (71%). In the current study we investigated cross-sectional adherence with the mt-sDNA test in a broader, national sample of insured patients. Methods: Aggregate data from Exact Sciences Laboratories LLC (ESL; Madison, WI) were retrospectively analyzed in compliance with HIPAA requirements. Study participants included individuals ages 50 years and older who were covered by commercial insurance or Medicare, had a valid mt-sDNA test order placed between January 1–December 31, 2018, and received a test kit shipped from ESL. Cross-sectional adherence, defined as successful completion and return of the test kit within 365 days of the shipment date, was assessed overall and by patient- and provider-level factors. Results: In total, 1,420,460 participants met the study criteria (61.2% women; mean age 65.7 years). Overall cross-sectional adherence was 66.8%. Adherence was 72.1% in participants with Traditional Medicare, 69.1% in participants with Medicare Advantage, and 61.9% in participants with commercial insurance (p&lt;0.001). Adherence increased by participant age (p&lt;0.001): 60.8% for ages 50-64, 71.3% for ages 65-75, and 74.7% for ages 76+ years. For Traditional Medicare patients, ages 65-75, adherence was 73.6%. Participants with mt-sDNA tests ordered placed by gastroenterologists had a higher adherence rate (78.3%) than those with orders placed by primary care clinicians (67.2%) (p&lt;0.001). Adherence rates were highest among patients with ordering providers in the Pacific region (71.4%) and West North Central region (70.1%), and lowest in the Mid-Atlantic region (65.7%), New England (65.2%), West South Central region (64.6%), and Puerto Rico and US territories (60.7%). Conclusions: Novel data from this large, national sample of insured patients demonstrate high cross-sectional adherence with the mt-sDNA test (66.8%), supporting the substantial contribution this guideline-endorsed option plays in average-risk CRC screening. At the patient-level, adherence increased with patient age, and was highest in those covered by Traditional Medicare. Provider-level stratification showed the highest adherence for mt-sDNA tests ordered by gastroenterologists. This study adds to data regarding the impact of accompanying navigation support and at-home convenience of mt-sDNA on screening completion rates.

Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45-49 Year-Olds: A Cross-Sectional Study.

High-specificity colorectal cancer screening is desirable to triage patients <50 years for colonoscopy; however, most endorsed colorectal cancer screening tests have not been rigorously evaluated in younger populations. This prospective cross-sectional study determined the specificity of the multitarget stool DNA (mt-sDNA) test in an average-risk screening population of 45 to 49 year-olds. Specificity was the primary outcome and was measured in participants without colorectal cancer or advanced precancerous lesions [APL- advanced adenomas (AA), and sessile serrated lesions ≥10 mm], and in the subgroup of participants with negative colonoscopic findings. APL sensitivity was a secondary outcome. The evaluable cohort included those who completed the study without protocol deviations and had a usable mt-sDNA test. Of 983 enrolled participants, 816 formed the evaluable cohort, with a mean age of 47.8 (SD, 1.5) years; 47.7% were women. No participants had colorectal cancer, 49 had APL, 253 had nonadvanced adenomas (NAA), and 514 had negative colonoscopic findings. mt-sDNA test specificity was 95.2% (95% CI, 93.4-96.6) in participants with NAA or negative findings [96.3% (confidence interval (CI), 94.3%-97.8%)] in those with negative findings, and did not differ by sex (P = 0.75) or race (P = 0.36) in participants with NAA or negative findings. Sensitivity for APL was 32.7% (CI, 19.9-47.5%), with most APL (83.7%) measuring 10-19 mm and none having high-grade dysplasia. The area under the ROC curve for discriminating between APL and lesser findings was 0.72 (CI, 0.64-0.81). mt-sDNA's high specificity would help minimize risk from unnecessary diagnostic procedures in this age group. This study shows that mt-sDNA has high specificity among average-risk 45 to 49-year olds, supporting its use as a noninvasive option for colorectal cancer screening. PREVENTION RELEVANCE: This study shows that mt-sDNA has high specificity among average-risk 45-49 year olds, supporting its use as a non-invasive option for colorectal cancer screening.

Barriers to Follow-Up Colonoscopy After Positive FIT or Multitarget Stool DNA Testing.

Fecal immunochemical testing (FIT) and multi-target stool DNA testing (mt-sDNA) are recommended colorectal cancer screening options but require follow-up with colonoscopy to determine the source of a positive result. We performed a retrospective analysis in an academic health system to determine adherence to colonoscopy in these patients. We identified all patients aged 40 years and older with at least 1 primary care visit who had a positive FIT or mt-sDNA between January 2016 and June 2018. We identified receipt of colonoscopy within 6 months of the positive test and reviewed medical records to determine reasons for lack of colonoscopy. We identified 308 eligible patients with positive FIT and 323 with positive mt-sDNA. Some patients with positive FIT (46.7%) and patients with positive mt-sDNA (71.5%) underwent colonoscopy within 6 months, and time to colonoscopy was also shorter with mt-sDNA (hazard ratio, 1.83; 95% CI, 1.48-2.25). These differences remained in a multivariable model adjusting for patient characteristics. Among patients without colonoscopy after positive FIT, 1 or more system, provider, and patient-related barriers were identified in 32.1%, 57.6%, and 36.3%, respectively. Among patients without colonoscopy after positive mt-sDNA, corresponding frequencies were 30.4%, 43.5%, and 57.6%, respectively. Follow-up colonoscopy was higher for mt-sDNA than FIT, which could be due in part to preselection by clinicians and/or patients. Among patients who did not follow-up, provider and system factors were as frequently encountered as patient factors. These findings reinforce the need for multi-level interventions to improve follow-up.

Evaluating Outreach Methods for Multi-Target Stool DNA Test for Colorectal Cancer Screening Among an Employer Population.

Introduction/Objectives:Despite compelling evidence of clinical and economic benefits, adherence to colorectal cancer (CRC) screening remains low. Increasing public awareness through various outreach methods may improve screening uptake. The objective of this study was to evaluate the uptake of non-invasive multi-target stool DNA (mt-sDNA) by different outreach methods in an average-risk employer population.Methods:This retrospective observational study included CRC screening-eligible individuals aged ≥50 years insured by the Metropolitan Nashville Public Schools (MNPS) employee healthcare plan. The study intervention arms included population-based outreach and office visit-based interaction. The mt-sDNA completion rate (proportion of individuals who return the mt-sDNA kit after consenting to have it shipped to their home), proportion of patients who performed follow-up colonoscopy after a positive test, and time to follow-up colonoscopy were assessed.Results:A total of 167 mt-sDNA kits were shipped to eligible participants (aged 50-64 years) in the population-based outreach arm. In the office visit-based interaction arm, a total of 132 mt-sDNA kits were shipped to eligible participants (aged ≥50 years). The mt-sDNA completion rate was significantly higher for office visit-based interaction as compared to population-based outreach (76.8% vs 53.5%; P < .001) among those aged 50 to 64 years. While all patients aged 50 to 64 years with a positive mt-sDNA result received a follow-up colonoscopy in both arms, the median time to follow-up colonoscopy was shorter among the population-based outreach (55 vs 136 days; P < .05).Conclusions:Office visit-based interaction was associated with a higher mt-sDNA completion rate as compared to the population-based outreach among average-risk, CRC screening-eligible individuals aged 50 to 64 years old.