Authors' recommendations: Colorectal cancer (CRC) is 1 of the leading causes of cancer-related deaths in the United States. It is estimated that 136,830 individuals will be diagnosed with CRC in 2014, and more than 50,000 will die from the disease. The 5-year survival rate for patients with cancer localized to the colon or rectum is approximately 90%, but it is less than 13% for those with distant metastases. Routine screening for CRC allows for the early detection and removal of early-stage cancers or precancerous polyps, resulting in improved overall survival. Consequently, the U.S. Preventive Services Task Force (USPSTF) and other national organizations recommend that individuals of average risk begin screening for CRC at age 50, using colonoscopy (the reference standard for CRC diagnosis) every 10 years, flexible sigmoidoscopy every 5 years, or fecal testing for blood cells annually; the sensitivities of these tests vary considerably. Despite current recommendations and the knowledge that screening may improve survival, it is estimated that at least 35% of Americans age 50 and older do not adhere to the current screening guidelines. Because of poor compliance and the lower sensitivity of currently available noninvasive screening methods, recent studies have focused on the development of high-sensitivity screening tools that may be considered more acceptable to eligible individuals and would increase overall compliance rates. One recently developed stool-based CRC screening test is Cologuard, which received premarket approval from the Food and Drug Administration (FDA) in August 2014. Cologuard analyzes DNA present in stool for certain genetic changes associated with cancerous or precancerous growths in the colorectal tissues. The test looks for changes that may result in the decreased expression of the bone morphogenetic protein 3 gene (BMP3) and n-MYC downstream-regulated gene 4 (NDRG4), both of which are associated with colorectal tumor growth. In addition, the assay tests for specific sequence variants in the Kirsten rat sarcoma viral oncogene homolog (the KRAS gene), which are known to be associated with the development of CRC. Finally, the assay tests for the presence of red blood cells in the stool sample, which may be another indication of a colorectal lesion. Using a complex algorithm to distinguish positive and negative results, the analysis is able to detect both CRC and advanced adenomas (AAs) that may become malignant if not removed. According to the test manufacturer, it is expected that use of the Cologuard test may significantly reduce the number of invasive screening procedures performed, while increasing patient compliance with current screening recommendations.

Project Status: Completed

Year Published: 2014

URL for published report: The report may be purchased from: http://www.hayesinc.com/hayes/crd/?crd=17132

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: 2014 Winifred S. Hayes, Inc