ColoHealth Direct is a screening test, designed to detect colorectal cancer early to improve long term prognosis.
ColoHealth Direct is an in vitro test that detects methylated Septin 9 DNA in human plasma, and is less invasive than other methods such as colonoscopy, sigmoidoscopy, and high sensitivity fecal occult blood testing.
ColoHealth Direct is not intended to replace traditional CRC screening methods. When indicated by risk level, patients should be tested for CRC using traditional methods.
Specificity & Sensitivity for ColoHealth/Epi proColon
* Note: A positive ColoHealth Direct result should be followed by diagnostic colonoscopy.
The mSEPT9 biomarker underlying ColoHealth Direct has been studied across multiple clinical studies involving more than 14,000 participants. The performance values above are derived from the pivotal clinical analysis of the FDA-approved ColoHealth/Epi proColon assay.
The total number of cases analyzed for the statistics above was 1,544 individuals (men and women, ages 50-85 who were not considered at a higher risk of developing CRC. Excluded patients included those with rectal bleeding, fresh blood in their stool, or those with an iron deficiency)
In a peer-reviewed study of early-onset colorectal cancer, mSEPT9 demonstrated 90.8% sensitivity and 88.9% specificity for EOCRC detection. Additional prospective studies are needed to further evaluate performance in younger screening populations.
References
“Quantifying the impact of adherence to screening strategies on colorectal cancer incidence and mortality”, Published: 28 November 2019, Authors: Elvira D'Andrea, Dennis J Ahnen, Daniel A Sussman, Mehdi Najafzadeh https://pubmed.ncbi.nlm.nih.gov/31777197/
“Methylated Septin9 (mSEPT9): A Promising Blood-Based Biomarker for the Detection and Screening of Early-Onset Colorectal Cancer”, Published: 11 February 2022, Authors: Loomans-Kropp HA, Song Y, Gala M, et al. https://pubmed.ncbi.nlm.nih.gov/35992328/
“Colorectal Cancer: Screening”, Published: 18 May 2021, Authors: US Preventive Services https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/colorectal-cancer-screening
Ordering Process:
Complete the test requisition form
Ship Blood Sample Collection Kit to Protean’s laboratory with completed TRF
Receive results within 7-10 business days
Sample Requirements:
Whole Blood
Order ColoHealth Direct
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