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INDICATIONS FOR USE

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).

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.

WARNINGS, LIMITATIONS, & PRECAUTIONS

The ColoHealth Direct™ test is not intended to replace colorectal cancer screening tests that are recommended by appropriate guidelines (e.g., 2021 USPSTF guidelines) such as colonoscopy, sigmoidoscopy, and high sensitivity fecal occult blood testing. The ColoHealth Direct test is not intended for patients who are willing and able to undergo routine colorectal cancer screening tests that are recommended by appropriate guidelines.

There is limited research data currently available demonstrating that ColoHealth Direct could be indicated for those under age 50 and/or those with the following conditions: those with an elevated risk of developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD), chronic ulcerative colitis, Crohn’s disease, familial adenomatous polyposis, family history of CRC, hereditary cancer syndrome (HNPCC or Lynch Syndrome), Peutz-Jeghers syndrome, MAP, Gardner’s syndrome, Turcot’s (Crail’s) syndrome, Cowden’s syndrome, Cronkhite-Canada syndrome, Neurofibromatosis, Familial Hyperplastic Polyposis, or in those with anorectal bleeding hematochezia, or with known iron deficiency anemia.

REFERENCES

Loomans-Kropp HA, Song Y, Gala M, Parikh AR, Van Seventer EE, Alvarez R, Hitchins MP, Shoemaker RH, Umar A. Methylated Septin9 (mSEPT9): A promising blood-based biomarker for the detection and screening of early-onset colorectal cancer. Cancer Res Commun. 2022 Feb;2(2):90-98. doi: 10.1158/2767-9764.crc-21-0142. Epub 2022 Feb 11. PMID: 35992328; PMCID: PMC9387652.

Song, L., Jia, J., Peng, X. et al. The performance of the SEPT9 gene methylation assay and a comparison with other CRC screening tests: A meta-analysis. Sci Rep 7, 3032 (2017). https://doi.org/10.1038/s41598-017-03321-8

Hitchins MP, Vogelaar IP, Brennan K, Haraldsdottir S, Zhou N, Martin B, Alvarez R, Yuan X, Kim S, Guindi M, Hendifar AE, Kalady MF, DeVecchio J, Church JM, de la Chapelle A, Hampel H, Pearlman R, Christensen M, Snyder C, Lanspa SJ, Haile RW, Lynch HT. Methylated SEPTIN9 plasma test for colorectal cancer detection may be applicable to Lynch syndrome. BMJ Open Gastroenterol. 2019 May 28;6(1):e000299. doi: 10.1136/bmjgast-2019-000299. PMID: 31275589; PMCID: PMC6577308.

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