Fecal Globin by Immunochemistry (InSure ONE)
Fecal Globin by Immunochemistry (InSure ONE)
This test is used to screen for lower gastrointestinal bleeding associated with disorders such as diverticulitis, ulcerative colitis, polyps, colorectal cancers, or large adenomas that bleed.
Fecal Globin by Immunochemistry (InSure® ONE™) Test code: 11290 Clinical use Clinical background CRC is the third most common cancer and second leading cause of cancer death in the United States.1 The American Cancer Society (ACS) estimates there will be >154,000 new cases of CRC in 2025 and about 53,000 deaths.1 Since the mid-2000s, mortality rates have been increasing by about 1% per year for people under age 55.1 The US Preventive Services Task Force and the ACS recommend screening starting at age 45 for people who are at average risk for CRC.2,3 Average risk for CRC is characterized by the patient having no personal or family history of CRC or certain types of polyps (eg, adenomatous polyps, hyperplastic polyps) yet presenting with a personal history of inflammatory bowel disease or cancer treatment involving radiation therapy to the abdomen or pelvic area, or a confirmed or suspected hereditary CRC syndrome (eg, familial adenomatous polyposis, Lynch syndrome).2,3 For individuals with increased or high risk (ie, individuals with a strong family or personal history), screening should begin at an earlier age.2,3 Screening for CRC effectively reduces incidence and mortality by ≥50%.4,5 Early detection is crucial, as survival rates decrease dramatically with increasing cancer stage. The 5-year survival rate is 91% for persons with disease confined to the primary site but only 13% for those with distant metastasis.6 Most CRCs begin as adenomatous polyps, which take ≥10 years to undergo malignant transformation.7 This long transformation period is one of the reasons CRC screening is so effective: precancerous lesions can be identified and removed before becoming cancerous. Cancerous and precancerous colorectal lesions tend to cause low-level bleeding, making tests for occult blood in stool an important screening tool. Fecal occult blood tests (FOBTs) fall into 2 main categories: guaiac-based fecal occult blood tests (gFOBTs) and fecal immunochemical tests (FITs). A drawback to gFOBTs is that they detect heme peroxidase activity and are not specific for human hemoglobin. Thus, hemoglobin from red meat, peroxidase from fruits and vegetables, and certain medications can cause false-positive results. In addition, vitamin C (excess of 250 mg/day) from supplements or citrus fruits and juices may cause a false-negative guaiac test result.8 A special diet is frequently recommended for several days before the test. Because gFOBTs can miss tumors with low-level, intermittent, or no bleeding, 3 successive stool specimens should be tested.3 In contrast, FITs do not react with nonhuman hemoglobin or peroxidase, eliminating the need for food restrictions prior to testing for people at average risk for CRC.3 In addition, some FITs require only 1 specimen per year.3 FITs are also specific for lower gastrointestinal bleeding because they target the globin portion of hemoglobin, which does not survive passage through the upper gastrointestinal tract. FITs also have better sensitivity than gFOBTs for detecting CRC.9 In a case-control study, FIT completion was associated with lower risk of overall death from CRC.9 Quest Diagnostics offers Fecal Globin by Immunochemistry (InSure®) (test code 11290), which uses the InSure® ONE™ test, a FIT-type FOBT that requires 2 specimens from a single bowel movement. InSure® ONETM exhibits acceptable overall agreement with its predicate InSure® FIT™ test, which required 2 specimens from 2 different bowel movements.10 Individuals suitable for testing
Method Interpretive information A "detected" result indicates occult blood in the feces and should be followed up with physician consultation and possible endoscopic evaluation. A "not detected" result indicates the absence of fecal blood; however, false-negative results can occur because of uneven distribution of blood in the feces or intermittent bleeding. A positive result does not necessarily mean the patient has colorectal cancer. Blood in fecal samples may indicate lower gastrointestinal bleeding associated with disorders such as diverticulitis, ulcerative colitis, polyps, colorectal cancers or large adenomas that bleed. References Content reviewed 03/2025Test Summary
This test is used to screen for lower gastrointestinal bleeding associated with disorders such as diverticulitis, ulcerative colitis, polyps, colorectal cancers, or large adenomas that bleed.
Fecal Globin by Immunochemistry (InSure® ONE™) Test code: 11290 Clinical use Clinical background CRC is the third most common cancer and second leading cause of cancer death in the United States.1 The American Cancer Society (ACS) estimates there will be >154,000 new cases of CRC in 2025 and about 53,000 deaths.1 Since the mid-2000s, mortality rates have been increasing by about 1% per year for people under age 55.1 The US Preventive Services Task Force and the ACS recommend screening starting at age 45 for people who are at average risk for CRC.2,3 Average risk for CRC is characterized by the patient having no personal or family history of CRC or certain types of polyps (eg, adenomatous polyps, hyperplastic polyps) yet presenting with a personal history of inflammatory bowel disease or cancer treatment involving radiation therapy to the abdomen or pelvic area, or a confirmed or suspected hereditary CRC syndrome (eg, familial adenomatous polyposis, Lynch syndrome).2,3 For individuals with increased or high risk (ie, individuals with a strong family or personal history), screening should begin at an earlier age.2,3 Screening for CRC effectively reduces incidence and mortality by ≥50%.4,5 Early detection is crucial, as survival rates decrease dramatically with increasing cancer stage. The 5-year survival rate is 91% for persons with disease confined to the primary site but only 13% for those with distant metastasis.6 Most CRCs begin as adenomatous polyps, which take ≥10 years to undergo malignant transformation.7 This long transformation period is one of the reasons CRC screening is so effective: precancerous lesions can be identified and removed before becoming cancerous. Cancerous and precancerous colorectal lesions tend to cause low-level bleeding, making tests for occult blood in stool an important screening tool. Fecal occult blood tests (FOBTs) fall into 2 main categories: guaiac-based fecal occult blood tests (gFOBTs) and fecal immunochemical tests (FITs). A drawback to gFOBTs is that they detect heme peroxidase activity and are not specific for human hemoglobin. Thus, hemoglobin from red meat, peroxidase from fruits and vegetables, and certain medications can cause false-positive results. In addition, vitamin C (excess of 250 mg/day) from supplements or citrus fruits and juices may cause a false-negative guaiac test result.8 A special diet is frequently recommended for several days before the test. Because gFOBTs can miss tumors with low-level, intermittent, or no bleeding, 3 successive stool specimens should be tested.3 In contrast, FITs do not react with nonhuman hemoglobin or peroxidase, eliminating the need for food restrictions prior to testing for people at average risk for CRC.3 In addition, some FITs require only 1 specimen per year.3 FITs are also specific for lower gastrointestinal bleeding because they target the globin portion of hemoglobin, which does not survive passage through the upper gastrointestinal tract. FITs also have better sensitivity than gFOBTs for detecting CRC.9 In a case-control study, FIT completion was associated with lower risk of overall death from CRC.9 Quest Diagnostics offers Fecal Globin by Immunochemistry (InSure®) (test code 11290), which uses the InSure® ONE™ test, a FIT-type FOBT that requires 2 specimens from a single bowel movement. InSure® ONETM exhibits acceptable overall agreement with its predicate InSure® FIT™ test, which required 2 specimens from 2 different bowel movements.10 Individuals suitable for testing
Method Interpretive information A "detected" result indicates occult blood in the feces and should be followed up with physician consultation and possible endoscopic evaluation. A "not detected" result indicates the absence of fecal blood; however, false-negative results can occur because of uneven distribution of blood in the feces or intermittent bleeding. A positive result does not necessarily mean the patient has colorectal cancer. Blood in fecal samples may indicate lower gastrointestinal bleeding associated with disorders such as diverticulitis, ulcerative colitis, polyps, colorectal cancers or large adenomas that bleed. References Content reviewed 03/2025Test Summary