Recent data shows that colon cancer is now the leading cause of U.S. cancer deaths in adults under 50. While this news is concerning, here’s a reassuring fact: When caught early, colon cancer is highly treatable, and with routine screening, precancer detection can help prevent cancer from developing in the first place.
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40%
Eligible adults remain unscreened.
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76%
Patients who died from CRC were not up to date with screening
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95%
Cases can be successfully treated when detected before they spread.
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1 in 24
Lifetime risk of developing colorectal cancer
Understanding Your Risk
Colorectal Cancer Doesn't Always Show Symptoms
Common Signs to Watch For
- Blood in your stool
- Changes in bowel habits
- Persistent abdominal discomfort
- Unexplained weight loss
- A feeling that your bowel doesn't empty completely
Note: Many people with early colorectal cancer experience no symptoms at all. Routine screening is designed to help detect potential issues before symptoms develop.
When to screen for colon cancer
Why it’s important to screen
Common Signs to Watch For
- Colon cancer is now the #1 cause of cancer-related deaths among adults under 50³
- 3 out of 4 patients under 50 are diagnosed with advanced colon cancer⁴
- It's the only type where its mortality rate has increased since 2005, compared to the 4 other leading causes of cancer death.
Why People Delay Screening
Common Concerns.
Better Solutions.
What Might Hold You Back
How ColoHealth Direct Helps
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Colonoscopy feels intimidating
Simple blood-based screening
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Too busy to schedule procedures
Home or partner collection options
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Don't know where to begin
Guided screening journey
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Concerned about accuracy
Physician-reviewed process
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.
ColoHealth 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