ColoHealth is an FDA approved screening test, designed to detect colorectal early to improve long term prognosis.
ColoHealth is an in vitro test that detects methylated Septin 9 DNA blood specimens transported in EDTA plasma, and is less invasive than other methods such as colonoscopy, sigmoidoscopy, and high sensitivity fecal occult blood testing.
Not intended to replace traditional CRC screening methods. Indicated risk by should be tested for CRC using traditional methods.
Specificity & Sensitivity for ColoHealth
* Note: Follow up with Grail or colonoscopy would be appropriate for higher risk set (PPV 30-40%, NPV: 70-60%).
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)
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/
“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 3-5 business days
Sample Requirements:
Whole Blood
Order ColoHealth
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