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ColoHealth Direct™
A Smarter Way to Screen for Colorectal Cancer.
- Blood-Based Screening
- Clinician guided screening process
- CLIA-Certified Laboratory Testing
$299.00
What's in the box?
Who should take this test?
What can I expect from my results?
From Purchase to Results, We've Simplified Every Step.
A guided screening journey designed to make preventive care more convenient, transparent, and accessible.
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Purchase Your Screening
Choose ColoHealth Direct online and complete a few simple eligibility details.
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Schedule Your Collection
Select a home blood collection or visit a nearby partner collection center.
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Laboratory Processing
Your sample is tested in our CLIA-certified laboratory under the oversight of a board-certified medical director.
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Receive Your Results
Access your secure digital report through your patient account. If follow-up is clinically appropriate, our team will provide guidance and support.
Your Care Continues Beyond Screening
Your screening journey doesn't end with your report. If clinically appropriate, our care team helps guide you through understanding your results and the recommended next steps.
- Secure digital results
- Clinician-reviewed guidance
- Follow-up recommendations when appropriate
- Patient support throughout your journey
THE SCIENCE BEHIND COLOHEALTH DIRECT
Built on Science. Designed for Earlier Insight.
Backed by more than a decade of clinical research, methylated SEPT9 (mSEPT9) is one of the most rigorously evaluated blood-based biomarkers for colorectal cancer screening. Its performance has been validated through numerous peer-reviewed studies, large prospective clinical trials, real-world evidence, and multiple independent meta-analyses, culminating in its use as the first FDA-approved blood-based screening test for colorectal cancer.
Know More
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01 — Blood Collection
A simple blood sample. No stool test required.
Your blood sample is collected through your preferred home collection or partner collection location, making screening simple and convenient.
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02 — Biomarker Analysis
Focused on one proven biomarker.
Using advanced molecular techniques, your sample is analyzed for methylated SEPT9 (mSEPT9), a clinically validated biomarker associated with colorectal cancer.
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03 — Clinical Review
Expert oversight. Personalized next steps.
Your results are reviewed within a Clinician guided clinical process to help ensure appropriate follow-up when needed.
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04 — Clear Results
Results you can trust. Support when you need it.
Your secure digital report provides your screening results, and our clinical team is available to help guide appropriate follow-up when necessary.
Why ColoHealth Direct?
A Screening Experience Designed Around You
| Feature | Traditional Screening Experience |
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|---|---|---|
| Collection | May involve more preparation depending on the screening method | Simple blood-based collection |
| Convenience | May require additional appointments or preparation | Home or Patient Service Center Collection |
| Clear and transparent pricing | Costs may vary | Transparent self-pay pricing |
| Clinical Confidence | Varies by provider and screening method | Clinician guided process |
| Transparent Experience | Follow-up process may differ | Clear updates from order to results |
| Digital Access | Report delivery varies | Secure digital report access |
| Fits Your Schedule | Limited flexibility | Choose a collection option that works for you |
Manage Your Screening
Everything you need after ordering—from collection guidance to tracking your kit and viewing your results.
Complete Your Collection
After delivery, the healthcare professional you selected will visit your home or work to collect your sample.
Track Kit or View Results
Track your order and access your results securely.
Login to knowReceive Your Kit
Your kit is delivered to your selected address.
Visit Your Selected Center
After delivery, take your kit to the collection center you selected to have your blood sample collected.
Track Kit or View Results
Track your order and access your results securely.
Login to know
Contact Our Team
Have questions about your collection? Our team can help guide you through the next steps.
ContactSend Your Sample
You'll receive a text with pickup instructions. Confirm when ready, and we'll arrange sample pickup.
Track Kit or View Results
Track your order and access your results securely.
Login to knowColoHealth Direct is a blood-based laboratory-developed test (LDT) used as an aid in colorectal cancer screening. The test looks for methylated SEPT9 (mSEPT9) DNA in a blood sample. SEPT9 is a molecular biomarker associated with colorectal cancer.
ColoHealth Direct provides a screening option that does not require bowel preparation, stool collection, sedation, or an invasive procedure. It is a screening test and is not intended by itself to diagnose colorectal cancer.
supporting references
- Potter NT, Hurban P, White MN, et al. Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma. Clinical Chemistry. 2014;60(9):1183-1191. doi:10.1373/clinchem.2013.221044. Link
- ColoHealth Direct, FAQs for Consumers (current company website). Link
SEPT9 is a gene normally found in human cells. In colorectal cancer, a chemical change called methylation can occur in a portion of the SEPT9 gene. DNA carrying this methylation pattern can be released into the bloodstream.
ColoHealth Direct analyzes blood for methylated SEPT9, or mSEPT9, DNA. When the mSEPT9 signal meets the test criteria for a positive result, it can indicate an increased likelihood that colorectal cancer may be present and that further evaluation is appropriate.
Supporting references
- Potter NT, Hurban P, White MN, et al. Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma. Clinical Chemistry. 2014;60(9):1183-1191. doi:10.1373/clinchem.2013.221044. Link
- ColoHealth Direct, FAQs for Consumers (current company website). Link
Eligibility for ColoHealth Direct is determined after completion of a brief health questionnaire reviewed by a licensed healthcare professional.
For adults at average risk, major colorectal cancer screening guidelines recommend beginning routine screening at age 45. However, colorectal cancer is increasingly being diagnosed in younger adults, including individuals who fall below the age for routine population screening.
Research evaluating mSEPT9 in early-onset colorectal cancer has demonstrated that the biomarker can be detected in adults younger than 50, including patients in their 20s, 30s and early 40s. In one published study of early-onset colorectal cancer, patients ranged from approximately 26 to 49 years of age, and mSEPT9 demonstrated strong detection performance across the studied younger age groups.
For this reason, ColoHealth Direct may be considered for some adults younger than 45 following clinician review based on their age, health and family history, individual risk factors, prior screening, and other relevant clinical considerations.
People experiencing rectal bleeding, persistent changes in bowel habits, unexplained iron-deficiency anemia, abdominal pain, or other concerning symptoms should seek medical evaluation. A screening blood test should not be used as a substitute for appropriate diagnostic evaluation of symptoms.
Supporting references
- 1. Wolf AMD, Hoffman RM, Walter LC, et al. Colorectal cancer screening: an update to the American Cancer Society guideline, 2026. CA Cancer J Clin. 2026;76(3):e70083. doi:10.3322/caac.70083. Link
- Loomans-Kropp HA, Song Y, Gala M, et al. Methylated Septin9 (mSEPT9): A Promising Blood-Based Biomarker for the Detection and Screening of Early-Onset Colorectal Cancer. Cancer Res Commun. 2022;2(2):90-98. doi:10.1158/2767-9764.CRC-21-0142. The EOCRC cases ranged from approximately 25.9 to 49 years old; mSEPT9 was detected in 24 of 27 cases. Link
- National Cancer Institute. Study Identifies Potential Warning Signs of Colorectal Cancer in Younger Adults. June 15, 2023. NCI notes that half of early-onset colorectal cancers are diagnosed in people younger than 45, outside routine average-risk screening recommendations. Link
- American Cancer Society. Colorectal Cancer Statistics, 2026 - Fast Facts. CRC incidence increased approximately 3% per year among adults ages 20-49 during 2013-2022, and three in four CRCs diagnosed before age 50 were regional- or distant-stage disease. Link
- ColoHealth Direct, FAQs for Clinicians (current company website). Link
- ColoHealth Direct, How It Works (current company website). Link
ColoHealth Direct has demonstrated approximately 68.2% sensitivity and approximately 80% specificity for colorectal cancer. In practical terms, the test detected about 7 out of 10 colorectal cancers in the referenced clinical dataset and correctly returned a negative result in about 8 out of 10 people who did not have colorectal cancer.
The test also demonstrated a negative predictive value (NPV) of approximately 99.7% in the studied screening population. NPV depends on how common the disease is in the population being tested, so it should not be interpreted as meaning that the test is "99.7% accurate." No screening test detects every colorectal cancer, and false-positive and false-negative results can occur.
Supporting references
- Epi proColon Instructions for Use, clinical performance table: sensitivity 68.2%, specificity 78.8% (weighted specificity 80.0%), PPV 2.4%, NPV 99.7%. Link
- Potter NT, Hurban P, White MN, et al. Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma. Clinical Chemistry. 2014;60(9):1183-1191. doi:10.1373/clinchem.2013.221044. Link
- ColoHealth Direct, FAQs for Clinicians (current company website). Link
Based on approximately 80% specificity, some people who do not have colorectal cancer may still receive a positive screening result. A positive ColoHealth Direct result does not mean that you have colorectal cancer. It means that the mSEPT9 signal detected by the test met the criteria for a positive screening result.
The recommended follow-up after a positive blood-based screening result is a diagnostic colonoscopy. Colonoscopy may identify colorectal cancer, polyps or adenomas, other findings, or no significant abnormality.
Supporting references
- Epi proColon Instructions for Use, clinical performance table: sensitivity 68.2%, specificity 78.8% (weighted specificity 80.0%), PPV 2.4%, NPV 99.7%. Link
- Wolf AMD, Hoffman RM, Walter LC, et al. Colorectal cancer screening: an update to the American Cancer Society guideline, 2026. CA Cancer J Clin. 2026;76(3):e70083. doi:10.3322/caac.70083. Link
- ColoHealth Direct, FAQs for Consumers (current company website). Link