FAQ
For Consumers
Accuracy of ColoHealthTM
How accurate is this test?
ColoHealth Direct LDT is designed to help identify people who may have colorectal cancer and those who likely do not. In clinical studies, the test detected about 68% of colorectal cancer cases and correctly identified about 80% of people who did not have cancer. If your test result is negative, colorectal cancer is very unlikely. About 99.7% of people with a negative result do not have colorectal cancer. If the result is positive, your healthcare provider will recommend a follow-up colonoscopy to confirm the results.1,4
For adult patients aged 44 or under, the test detected about 91% of colorectal cancer cases and correctly identified about 89% of people who did not have cancer.3
False Positives
How common are false positives?
The term “false positive” can be somewhat misleading in the context of Colorectal cancer screening. While some patients with a positive results will not have colorectal cancer, follow-up colonoscopy often identifies other clinically meaningful findings. In one small clinical study, nearly 60% of individuals with a positive test were found to have a polyp or adenoma during colonoscopy. These lesions may be precancerous and clinically significant. As a result, a positive screening result can still lead to the detection and removal of abnormalities that may help prevent future colorectal cancer.1,4
Sign Up Process
How do I sign up for and take the test?
Getting started is simple and only takes a few steps:
1. Visit https://colohealthy.com/ and click “Get Your Kit Now”. Complete a short health questionnaire to confirm your eligibility.
2. If eligible, purchase your test online.
3. Schedule a convenient blood draw at a local patient service center, either before or after your kit arrives. After your blood draw, your part is complete. Your sample is sent to our laboratory for testing, and a physician reviews your results. Your results are then delivered securely to you, and you can easily share them with your doctor if you wish.
Location
Where are you located?
The headquarters lab is located at 2730 Cherokee Farm Way, Ste. 300, Knoxville, TN 37920. Check our website to learn about our nationwide network of partner laboratories.
Test Preparation
Do I have to fast before the test?
No fasting or special preparation is needed before your blood draw.
Screening for Non-Adherent Patients
How does the test benefit individuals who are unwilling to complete other screening methods?
Colorectal cancer screening saves lives, and everyone age 45 and older should be screened. ColoHealth Direct LDT provides a convenient and affordable blood-based option for individuals who are unwilling or unable to complete colonoscopy or stool-based screening tests.
Use in Younger or High-Risk Patients
Can ColoHealth Direct LDT be used for patients under 45 or those with a strong family history of colorectal cancer?
The test is intended for use in individuals who meet the indicated screening criteria. However, healthcare providers may use their clinical judgment when ordering the test for patients who fall outside these criteria.
Replacement for Other Tests
Does this test replace colonoscopy or FIT/stool DNA tests?
ColoHealth Direct LDT is intended as an alternative for individuals who are unwilling or unable to complete colonoscopy or other approved screening methods. It is designed to expand access to screening for patients who might otherwise go unscreened.2
Performance Comparison with ColoGuard
How does ColoHealth Direct LDT perform compared to ColoGuard?
Cologuard demonstrates higher sensitivity than the ColoHealth Direct LDT, while the two methods show similar specificity and negative predictive value. However, stool-based screening tests generally suffer from low patient adherence. When real-world adherence rates are considered, the ColoHealth Direct LDT has the potential to identify more colorectal cancer cases and prevent more colorectal cancer deaths. In contrast, DNA plus stool-based tests may face lower participation rates and relatively high testing costs.2
Blood Draw Requirements
Can a fingerstick blood draw work?
The test requires a standard venous blood draw using two (2) 10 mL K3 EDTA cell-free DNA blood collection tubes.
Dietary or Medication Restrictions
Are there any dietary or prescription medication restrictions before taking the test?
You can eat normally and continue taking your prescribed medications before the blood draw.
Positive Test Results
If my test result is positive, do I have cancer?
A positive result does not necessarily mean you have colorectal cancer. It indicates that additional evaluation is recommended. Patients with a positive result should follow up with their healthcare provider and undergo a diagnostic colonoscopy for confirmation.
Negative Test Results
If my test result is negative, does it mean I don’t have cancer?
A negative test result means colorectal cancer is very unlikely. The test has a negative predictive value (NPV) of 99.7%, meaning that 99.7% of people who receive a negative result do not have colorectal cancer.4 Regular screening is still recommended, and annual testing may be appropriate.
Gene and Cancer
Does a negative result mean I don’t have the gene that causes colorectal cancer?
Everyone has the SEPT9 gene. In fact, SEPT9 protein acts as a tumor suppressor. This test looks for methylated SEPT9 DNA. If the SEPT9 DNA is methylated, then expression of this tumor suppressor protein has been silenced.1
FDA Approval
Is this test FDA approved?
ColoHealth Direct is a laboratory-developed test (LDT) derived from the FDA-approved ColoHealth test, the first blood-based test approved by the FDA for colorectal cancer screening, and incorporates enhancements developed by our laboratory.
Test Cost and Coverage
What is the cost and does insurance cover this test?
Current pricing can be found on our website for direct access customers, while those who have a personal physician in our network can speak to their provider about pricing. Medicare does not currently provide coverage for this test. Some private insurance providers may cover the test, but coverage is not yet widespread. We encourage you to check with your insurance provider to confirm your specific benefits. Health Savings Accounts (HSA) may also be used to pay for the test. New Day does not file insurance claims for patients.
USPSTF Guidelines
Is ColoHealth Direct recommended in the USPSTF Guidelines?
ColoHealth Direct is not currently included in the most recent USPSTF colorectal cancer screening guidelines. However, blood-based screening tests have historically been considered an option for individuals who are unwilling or unable to complete other recommended screening methods.
*All clinical trial data and journal articles cited are for the FDA approved blood test for colorectal cancer screening known as Epi proColon. New Day Diagnostics has acquired all rights to the test and have re-branded the test ColoHealthTM.
Citations
- Potter N et al. (2014) Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma. Clin Chem 60(9):1183-1191.
- Johnson D et al. (2014) Plasma Septin 9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLOS ONE 9(6) e98238.
- Loomans-Kropp HA, Song Y, Gala M, Parikh AR, Van Seventer EE, Alvarez R, HitchinsMP, 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
- Liles et al (2017) Uptake of a colorectal cancer screening blood test is higher than ofa fecal test offered in a clinic: A randomized trial.
- D’Andrea et al. (2019) Quantifying the impact of adherence to screening strategies on colorectal cancer incidence and mortality. DOI: 10.1002/cam4.2735.
ColoHealth Direct: Simple. Convenient. Trusted.
Getting screened for colorectal cancer shouldn’t be a hassle. At ColoHealth Direct, we’ve designed a process that is as simple as it is effective. We believe in Convenience Without Compromise, and this guide will walk you through every step of your screening journey, so you know exactly what to expect.
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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