Frequently Asked
Questions
Find answers to common questions about ColoHealth Direct, screening process, results, and more.
GENERAL & CLINICAL
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. mSEPT9 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.
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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.
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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
- 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 . Link
- ColoHealth Direct, How It Works . 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 . 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 . Link
No. ColoHealth Direct is a laboratory-developed test (LDT) and has not been separately cleared or approved by the FDA.
New Day Diagnostics also owns ColoHealth, a separate FDA-approved colorectal cancer blood screening test based on mSEPT9 technology. ColoHealth Direct and the FDA-approved ColoHealth product are separate tests. ColoHealth Direct was developed using the same mSEPT9 detection methodology used in ColoHealth.
Supporting references
- U.S. Food and Drug Administration. Laboratory Developed Tests. Current page notes that the 2024 LDT final rule was vacated in 2025 and the regulation text was reverted. Link
- FDA Summary of Safety and Effectiveness Data for Epi proColon (P130001), including PRESEPT clinical performance. Link
- ColoHealth Direct, FAQs for Consumers . 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. Clin Chem. 2014;60(9):1183-1191. doi:10.1373/clinchem.2013.221044. Link
ColoHealth Direct uses a standard blood sample to look for a molecular signal associated with colorectal cancer. It does not require bowel preparation, stool collection, sedation, or an invasive procedure.
A colonoscopy directly examines the inside of the colon and rectum and can identify and remove polyps and obtain tissue samples. Stool-based screening tests look for blood and/or molecular markers in a stool sample.
Each screening method has advantages and limitations. ColoHealth Direct provides another option for people seeking a convenient blood-based approach. A positive ColoHealth Direct result should be followed by diagnostic colonoscopy.
Supporting references
- 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
- U.S. Preventive Services Task Force. Colorectal Cancer: Screening. Final Recommendation Statement. May 18, 2021. Link
- ColoHealth Direct, How It Works . Link
ColoHealth Direct is designed primarily to detect the mSEPT9 blood signal associated with colorectal cancer. It is not intended to rule out the presence of precancerous polyps.
Historical mSEPT9 clinical data demonstrated approximately 21.6% sensitivity for advanced adenomas, compared with approximately 68.2% sensitivity for colorectal cancer. Detection of advanced precancerous lesions remains a limitation of blood-based colorectal cancer screening generally; published studies of other contemporary blood-based CRC screening tests have reported advanced precancerous lesion sensitivities generally in the low-teens to low-20% range.
Colonoscopy remains the screening method that can directly visualize the colon, identify polyps, and remove certain precancerous lesions during the same procedure. Therefore, a negative ColoHealth Direct result does not mean that no polyps are present.
Supporting references
- Peterse EFP, Meester RGS, de Jonge L, et al. Comparing the Cost-Effectiveness of Innovative Colorectal Cancer Screening Tests. J Natl Cancer Inst. 2021;113(2):154-161. doi:10.1093/jnci/djaa103. Link
- Kahn et al. Blood-Based Circulating Tumor DNA Assays for Early Colorectal Cancer Detection: A Systematic Review of Performance in Asymptomatic Screening Populations. International Journal of Cancer. 2026. doi:10.1002/ijc.70498. Link
- Chung DC, Gray DM II, Singh H, et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024;390:973-983. doi:10.1056/NEJMoa2304714. Link
Major colorectal cancer screening guidelines recommend that adults at average risk begin regular screening at age 45.
In 2026, the American Cancer Society updated its colorectal cancer screening guideline to include blood-based screening as an option. The ACS states that blood-based tests are not currently preferred screening options and should be recommended to individuals who decline or have not completed a preferred high-sensitivity stool-based test or structural visual examination. The ACS also states that a positive non-colonoscopy screening result requires timely follow-up colonoscopy.
The current U.S. Preventive Services Task Force recommendation also begins average-risk screening at age 45, but its current recommendation does not include serum or blood-based tests among the listed screening strategies. ColoHealth Direct itself is not specifically named in either guideline.
Supporting references
- 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
- American Cancer Society. Colorectal Cancer Screening Guideline, updated 2026. Link
- U.S. Preventive Services Task Force. Colorectal Cancer: Screening. Final Recommendation Statement. May 18, 2021. Link
Internal/web-development note: The ACS 2026 guideline also notes uncertainty regarding the optimal repeat interval for blood-based tests. ColoHealth Direct annual-use language is therefore supported separately by the mSEPT9 literature and should not be described as an ACS-specified annual interval.
SCREENING PROCESS
The ColoHealth Direct process is designed to be simple: complete the online order and health questionnaire; a licensed healthcare professional reviews your information and, when appropriate, authorizes the laboratory test; receive your blood-collection kit and instructions; have a standard venous blood draw performed by a trained professional; the sample is returned to a qualified laboratory for analysis; and your result is delivered electronically when testing is complete.
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You do not need to obtain a prescription from your own physician before starting the ColoHealth Direct process. Clinician review is included as part of the service. After you complete the health questionnaire, a licensed healthcare professional reviews your information and, when appropriate, authorizes the laboratory test.
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ColoHealth Direct is not a fingerstick or self-collected blood test. It requires a standard venous blood draw performed by a trained healthcare or phlebotomy professional. There is no stool sample to collect at home.
Depending on your location and the services available in your area, blood collection may be arranged at a participating collection location or through an available mobile phlebotomy option.
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The blood draw itself is brief. Total appointment time can vary by collection location because of check-in, specimen labeling, and processing requirements. Follow the scheduling instructions provided with your order.
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No special diet, bowel preparation, or fasting is required before a ColoHealth Direct blood draw. You can eat normally and continue taking your prescribed medications unless your healthcare professional has specifically instructed you otherwise. Follow any collection instructions provided with your order.
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RESULTS & FOLLOW-UP
Results are typically expected within approximately 7 to 10 business days after an acceptable blood sample is received by the laboratory. Timing can vary because of shipping, specimen condition, laboratory volume, or the need for additional quality review.
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Internal/web-development note: The live site currently contains both 5-10 and 7-10 business-day statements. This draft uses 7-10. Confirm the final SLA and standardize the rest of the website.
You will be notified electronically when your ColoHealth Direct result is available. Your laboratory report will be delivered through the secure results process associated with your order, and you will be able to retain a copy for your records.
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A positive ColoHealth Direct result does not mean that you have colorectal cancer. It means that the test detected an mSEPT9 signal that meets the criteria for a positive screening result.
A positive blood-based screening result should be followed by diagnostic colonoscopy. Colonoscopy allows a physician to directly examine the colon and rectum and determine the reason for the positive screening result.
Supporting references
- 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 . Link
- ColoHealth Direct / New Day Diagnostics Terms and Conditions, including consent, cancellation, returns, shipping, and privacy/security language. Link
No screening test can completely rule out colorectal cancer. A negative ColoHealth Direct result means that the test did not detect an mSEPT9 signal meeting its positive criteria.
In the referenced screening population, the test demonstrated an NPV of approximately 99.7%, meaning colorectal cancer was very unlikely following a negative result in that population. False-negative results can still occur. A negative result does not eliminate the need for future colorectal cancer screening or appropriate evaluation of new or concerning symptoms.
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
- ColoHealth Direct, FAQs for Consumers . Link
- ColoHealth Direct / New Day Diagnostics Terms and Conditions, including consent, cancellation, returns, shipping, and privacy/security language. Link
Yes. Your ColoHealth Direct laboratory report can be shared by you with your primary care physician, gastroenterologist, or another healthcare professional. We encourage you to keep a copy of the report as part of your personal medical record.
New Day Diagnostics will ensure your result is available to you via your account but does not offer the service of transferring or sending results to clinicians and providers.
Supporting references
When ColoHealth Direct remains your chosen blood-based screening approach after a negative result, we recommend repeating the test annually.
Repeated screening matters because a negative result reflects one point in time. Published colorectal cancer screening models have evaluated mSEPT9 at different intervals. Annual mSEPT9 was identified as the most effective mSEPT9 interval compared with testing every two or three years. In one modeling analysis that incorporated published real-world adherence assumptions, annual SEPT9 screening was projected to avert 37 colorectal cancer cases and 23 colorectal cancer deaths per 1,000 people, compared with 34 cases and 20 deaths for colonoscopy every 10 years; under 100% adherence, the modeled benefits of the leading strategies were much closer and colonoscopy slightly exceeded annual SEPT9 for cases averted.
These are modeling results, not a head-to-head mortality trial. They support annual mSEPT9 as a practical repeated-screening strategy and show how adherence can materially affect the population benefit of a screening program. If you receive a positive ColoHealth Direct result, the next step is diagnostic colonoscopy rather than simply repeating the blood test.
Supporting references
- D'Andrea E, Ahnen DJ, Sussman DA, Najafzadeh M. Quantifying the impact of adherence to screening strategies on colorectal cancer incidence and mortality. Cancer Med. 2020;9(2):824-836. doi:10.1002/cam4.2735. Link
- Peterse EFP, Meester RGS, de Jonge L, et al. Comparing the Cost-Effectiveness of Innovative Colorectal Cancer Screening Tests. J Natl Cancer Inst. 2021;113(2):154-161. doi:10.1093/jnci/djaa103. Link
- ClinicalTrials.gov NCT03218423. Longitudinal Performance of Epi proColon (PERT), designed to assess annual repeated Epi proColon testing over two consecutive years. No results are posted in the public record reviewed. Link
- Liles EG, Coronado GD, Perrin N, et al. Uptake of a colorectal cancer screening blood test is higher than of a fecal test offered in clinic: a randomized trial. Cancer Treat Res Commun. 2017;10:27-31. doi:10.1016/j.ctarc.2016.12.004. Link
- Adler A, Geiger S, Keil A, et al. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014;14:183. doi:10.1186/1471-230X-14-183. Link
Internal/web-development note: Approved annual positioning should remain qualified as modeling evidence. Do not use an unqualified public claim that annual ColoHealth Direct "beats all other screening methods." The data support: under published real-world adherence assumptions, annual mSEPT9 produced the greatest modeled reduction in CRC cases and deaths among the strategies evaluated in that analysis.
Occasionally, a blood sample may not meet laboratory requirements because of insufficient specimen volume, shipping or handling issues, specimen condition, or laboratory quality-control requirements. If an acceptable result cannot be produced, you will be contacted with instructions regarding recollection or another required step. A result will not be reported from a specimen that does not meet applicable laboratory quality requirements.
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ORDERING & SHIPPING
Select "Get Your Kit" on the ColoHealth Direct website, complete the requested information and health questionnaire, and submit payment. A licensed healthcare professional reviews your information and, when appropriate, authorizes the test. You will then receive the kit, collection instructions, and blood-draw scheduling information.
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The current self-pay price for ColoHealth Direct is $299. The current offer includes the blood-collection kit, clinician review and authorization, blood-collection appointment, return shipping, laboratory testing, and electronic test report. Any change in included services or price should be reflected at checkout before purchase.
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After your order and clinician authorization are complete, your ColoHealth Direct kit is prepared for shipment. Delivery timing can vary by location, carrier schedules, weather, and other shipping conditions. Follow the shipping information provided with your order.
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You do not need to travel to Knoxville to use ColoHealth Direct. New Day Diagnostics operates a CLIA-certified laboratory in Knoxville, Tennessee, and also works with CLIA-certified partner laboratories across the country that can perform ColoHealth Direct at their facilities as some states require. Your kit comes with a prepaid shipping label and will be sent to New Day Diagnostics or one of our partner labs after your collection.
Availability, blood-collection options, and the laboratory used for your test may vary by location and applicable requirements. The ordering process will confirm whether ColoHealth Direct is available at your shipping address.
Supporting references
- ColoHealth Direct, FAQs for Consumers . Link
- ColoHealth Direct, FAQs for Clinicians . Link
- ColoHealth Direct checkout page: $299 price, included services, self-pay status, HSA/FSA processing, and state availability controls. Link
Internal/web-development note: The current checkout page excludes CA, NY, RI, MD, PA, and WV. Because state availability may change, this consumer answer intentionally directs users to checkout rather than hard-coding a state list into the FAQ.
INSURANCE, BILLING & PRIVACY
ColoHealth Direct is currently only offered as a self-pay direct-to-consumer service. New Day Diagnostics does not currently bill insurance providers, including Medicare, on behalf of direct-pay customers.
You may contact your insurance plan to ask whether reimbursement is available under your benefits and what documentation is required. Coverage is determined by the individual health plan and is not guaranteed.
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ColoHealth Direct is currently purchased through the website checkout as a one-time transaction. Any installment, financing, or other payment option that is available will be displayed during checkout before you complete your purchase.
Supporting references
- ColoHealth Direct checkout page: $299 price, included services, self-pay status, HSA/FSA processing, and state availability controls. Link
Yes. The current ColoHealth Direct checkout supports HSA and FSA payment cards. Individual HSA/FSA plans can have different documentation or eligibility requirements, so contact your plan administrator if you have questions about your specific account.
Supporting references
- ColoHealth Direct checkout page: $299 price, included services, self-pay status, HSA/FSA processing, and state availability controls. Link
Under the current ColoHealth Direct Terms and Conditions, ColoHealth Direct orders cancelled before administration of the test are subject to a 25% restocking fee. Testing services are non-refundable once the test has been administered. Opened, used, or contaminated test kits are not eligible for refund or exchange.
If a kit arrives damaged or you need to cancel an order, contact New Day Diagnostics promptly and follow the return or cancellation instructions in the Terms and Conditions.
Stopped Payment Claims appearing as fraudulent by attempting to receive reimbursement for payment are subject to FTC reporting.
Supporting references
- ColoHealth Direct / New Day Diagnostics Terms and Conditions, including consent, cancellation, returns, shipping, and privacy/security language. Link
Internal/web-development note: This answer intentionally follows the currently posted Terms and Conditions rather than the earlier proposed refund language. If New Day changes its commercial refund policy, update the Terms and this FAQ together.
ColoHealth Direct uses privacy and security safeguards designed to protect personal information collected through the website and testing process. The current Terms and Conditions state that website transmissions use SSL and encryption, and the Privacy Policy describes the information collected and how it is used.
Additional details about website data practices and testing/reporting consent are available in the ColoHealth Direct Privacy Policy and Terms and Conditions.