Introducing ColoHealth Direct
A Simpler Way to Screen for Colorectal Cancer
Request ColoHealth DirectEarly Detection. Simplified.
Making preventive screening simpler and easier to navigate.
- Blood-Based Screening
- Clinician Guided
- Home or Lab Collection
Why Screening Matters.
Colorectal cancer can develop without noticeable symptoms. Routine screening can help identify potential concerns before symptoms appear.
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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
| 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 |
Trusted results. Trusted care.
Every ColoHealth Direct screening is guided by healthcare professionals and supported by clinically established processes, CLIA-certified laboratory testing, and secure data handling. From screening to results, every step is designed to provide a trusted, transparent, and confident experience.
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Healthcare Professional-Guided
Clinical oversight throughout your screening journey.
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CLIA-Certified Laboratory
Samples are processed in certified laboratories following established quality standards.
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Secure & HIPAA Protected
Your health information is handled with privacy and security at every step.
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Trusted Results
Built on FDA-approved science to help deliver confidence in your screening experience.
ColoHealth Direct™
A Blood-Based Approach to Colorectal Cancer Screening.
- Clinician guided screening process
- Home or partner lab collection options
- CLIA-Certified Laboratory Testing
- Digital report delivery via your account
- End-to-end guided screening journey
$299
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.
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.
Discover
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Schedule Your Collection
Select a home blood collection or visit a nearby partner collection center.
View our coverage map
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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.
Is ColoHealth Direct Right for You?
ColoHealth Direct is designed to make clinician-reviewed colorectal cancer screening more accessible for eligible adults.
ELIGIBILITY POINTS
- Are considering routine colorectal cancer screening
- Complete a brief clinician-reviewed clinical assessment
- Meet the test's clinical eligibility criteria
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
ColoHealth Direct is designed as a simple, guided screening journey:
- Purchase your screening online and complete a brief eligibility questionnaire reviewed by a licensed healthcare professional.
- Schedule a home blood collection or visit a nearby partner collection location.
- Your sample is tested in a CLIA-certified laboratory under medical director oversight.
- Access your secure digital report in your patient account. If follow-up is clinically appropriate, our care team provides guidance and support.
This is a screening test and is not intended by itself to diagnose colorectal cancer.
Colorectal cancer is cancer that starts in the colon or rectum. It often begins as a growth called a polyp that can become cancer over time. Screening is intended to help find colorectal cancer earlier, when treatment may be more successful.
ColoHealth Direct is a blood-based screening option that looks for methylated SEPT9 (mSEPT9) DNA associated with colorectal cancer. It 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.
ABOUT US
Better Diagnostics. Built
Around People.
New Day Diagnostics is focused on making preventive healthcare more accessible, approachable, and easier to navigate. By bringing together scientific innovation, clinical expertise, and consumer-first experiences, we're building diagnostic solutions designed around the people who use them.
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Science-Led
Grounded in research and clinical evidence.
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People-First
Designed to make complex healthcare easier to understand.
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Built for What's Next
Creating a growing portfolio of modern diagnostic solutions.
