A systematic review of the clinical validity of the Cologuard™ genetic test for screening colorectal cancer

García, María Dolorès Vivero; Llanos-Méndez, Aurora; Baños‐Álvarez, Elena; Isabel‐Gómez, Rebeca

doi:10.1016/j.rceng.2015.08.006

Cited by 6 publications

(3 citation statements)

References 17 publications

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“…The majority of commercially available methylation-based tests designed for CRC screening use stool samples as a source of DNA, such as Colovantage ® [62] CologuardTM [62,63], and ColoSureTM [64], but only a few blood-based tests are currently available on the market.…”

Section: Single-cancer Detection Tests Colorectal Cancermentioning

confidence: 99%

Current Challenges of Methylation-Based Liquid Biopsies in Cancer Diagnostics

Rendek,

Pos,

Duranova

et al. 2024

Cancers

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In current clinical practice, effective cancer testing and screening paradigms are limited to specific types of cancer, exhibiting varying efficiency, acceptance, and adherence. Cell-free DNA (cfDNA) methylation profiling holds promise in providing information about the presence of malignity regardless of its type and location while leveraging blood-based liquid biopsies as a method to obtain analytical samples. However, technical difficulties, costs and challenges resulting from biological variations, tumor heterogeneity, and exogenous factors persist. This method exploits the mechanisms behind cfDNA release but faces issues like fragmentation, low concentrations, and high background noise. This review explores cfDNA methylation’s origins, means of detection, and profiling for cancer diagnostics. The critical evaluation of currently available multi-cancer early detection methods (MCEDs) as well as tests targeting single genes, emphasizing their potential and limits to refine strategies for early cancer detection, are explained. The current methodology limitations, workflows, comparisons of clinically approved liquid biopsy-based methylation tests for cancer, their utilization in companion diagnostics as well as the biological limitations of the epigenetics approach are discussed, aiming to help healthcare providers as well as researchers to orient themselves in this increasingly complex and evolving field of diagnostics.

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Section: Single-cancer Detection Tests Colorectal Cancermentioning

confidence: 99%

Current Challenges of Methylation-Based Liquid Biopsies in Cancer Diagnostics

Rendek,

Pos,

Duranova

et al. 2024

Cancers

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show abstract

“…The United States Food and Drug Administration has approved this test only for average-risk patients who are asymptomatic and aged 45 years and older. Patients with ongoing melena or hematochezia, a personal history of colorectal adenoma or inflammatory bowel disease, a family history of colorectal adenoma in a first-degree relative diagnosed at any age, or heritable cancer syndromes should not be offered this test[ 32 ]. We agree with the authors that the COVID-19 pandemic has presented various obstacles for prompt CRC screening.…”

Section: Emerging Screening Tools and Future Tests Might Be The Solut...mentioning

confidence: 99%

Barriers in early detection of colorectal cancer and exploring potential solutions

Aleissa,

Drelichman,

Mittal

et al. 2024

World J Clin Oncol

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This editorial discusses the literature review article by Tonini and Zanni, the paper was published in January 2024, and the authors provided very interesting conclusions regarding existing barriers to the early diagnosis of colon cancer. Many cancers do not have identifiable precursors, or there are currently no screening tests to find them. Therefore, these cancers do not have preventive screening options. Early detection is crucial for reducing mortality rates by identifying cancer at an earlier stage through screening, as opposed to no screening. Colorectal cancer develops from precancerous lesions, which can be detected early and potentially prevented and cured. Early detection leads to improved survival rates, decreased complications, and reduced healthcare expenses. This editorial provides a brief description of the biology of colon cancer, emphasizing the contrast in outcomes between early detection and late detection. We also describe screening programs around the globe and examine the barriers in each program. Finally, we explore potential future solutions to enhance inclusion in screening programs and improve patient compliance.

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“…May 2021 guideline changes offered a grade B recommendation for regular colorectal cancer screening beginning at age 45 and continuing through age 49 [ 6 ]. Regular screening, in general, entails adherence with a test or combination of tests including: colonoscopy every 10 years, flexible sigmoidoscopy every 5 years, CT colonography every 5 years, a stool DNA test (sDNA-Fit; e.g., Cologuard [ 7 , 8 ]) every 1 to 3 years, or a fecal occult blood test (FOBT) and/or fecal immunochemical test (FIT) every year. Some patient populations, however, do require modifications to timing of screening initiation and intervals (e.g., personal or family history of colorectal cancer, genetic risk, and current symptoms).…”

Section: Introductionmentioning

confidence: 99%

Intervention during wait time: identification and referral of individuals non-adherent for colorectal cancer screening

Abar

Park²,

Dalawari³

et al. 2022

Emerg Cancer Care

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Background Despite unanimous recommendations from numerous specialty societies on regular colorectal cancer screening, a substantial proportion of eligible adults are non-adherent with screening. The current study investigated whether research associates (RAs) in the emergency department (ED) can adequately assess patients’ adherence with colorectal cancer screening recommendations, outlined by the US Preventive Services Task Force (USPSTF), and provide referrals to individuals who are found to be non-adherent. Methods RAs at seven heterogeneous hospitals in the USA queried non-emergent adult patients and visitors between the ages of 50 and 75. After obtaining verbal consent, the participant’s adherence with USPSTF guidelines for colorectal cancer screening was assessed. Participants found due for screening were provided with referrals to obtain these recommended screenings. Results A total of 8258 participants were surveyed on their colorectal cancer screening status, with RAs identifying 2063 participants who were not adherent with USPSTF guidelines for colorectal cancer screening and 67 for whom adherence could not be determined (total 27%). Conclusions Our study demonstrates that RAs can identify a large volume of eligible adults who would benefit from colorectal cancer screening across a variety of emergency department settings.

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A systematic review of the clinical validity of the Cologuard™ genetic test for screening colorectal cancer

Cited by 6 publications

References 17 publications

Current Challenges of Methylation-Based Liquid Biopsies in Cancer Diagnostics

Current Challenges of Methylation-Based Liquid Biopsies in Cancer Diagnostics

Barriers in early detection of colorectal cancer and exploring potential solutions

Intervention during wait time: identification and referral of individuals non-adherent for colorectal cancer screening

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