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Is ColoHealth Right For You?

Click Here to read the following statements about ColoHealth, if you still wish to proceed, select YES when prompted.

Please read the following statements about ColoHealth, if you still wish to proceed, select YES when prompted.

ColoHealth Direct is a Laboratory Developed Test for the detection of methylated Septin 9. Methylated Septin 9 is a qualified predictor of early onset colorectal cancer.

ColoHealth Direct is intended for use in those who are age 50 or older, with no history of colon cancer, gastrointestinal abnormalities (such as IBS, Crohn’s disease, diverticulosis, etc), or symptoms of colon cancer (such as changes in bowel habits or blood in stool), no history of colon cancer in first degree relatives (mother, father, sibling), and no history of any hereditary cancer syndromes (such as Lynch syndrome).
In these populations the following apply:

Sensitivity 73.3%	(CI 95%, 63.9-80.9%)
Specificity 81.5%	(CI 95%, 75.5-86.3%)
NPV 99.6%	(95% CI, 99.6-99.8%)
PPV 3.0%

Research has shown that testing for methylated Septin 9 may be beneficial for other populations such as those who are under age 50, those who may be symptomatic, those who have had a family history of cancer, or those who may have a history of hereditary cancer syndromes. Test performance in individuals under 50 is limited to retrospective case-control data in a study of 27 early onset colorectal cancer cases with a median age of 44. The performance data in these populations include:

Sensitivity 90.8%	(95% CI, 84.7-96.9%)
Specificity 88.9%	(95% CI, 77.0-100.0%)
NPV 96.3%	(95% CI, 92.3-100.0%)
PPV 75.0%	(95% CI, 60.0-90.0%)

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