FAQ
For clinicians
Cross Reactivity
How specific is ColoHealth Direct LDT for colorectal cancer?
ColoHealth Direct LDT detects methylated Septin9 DNA, which is associated with the occurrence of colorectal cancer. Positive test results have been observed in patients with chronic gastritis, lung cancer, and in pregnant women.
Sensitivity/Specificity/NPV/PPV
What is the Sensitivity, Specificity, NPV, and PPV of ColoHealth Direct LDT ?
For patients currently in the recommended screening guidelines, the sensitivity is 68.2%, specificity is 80.0%, negative predictive value (NPV) is 99.7%, and positive predictive value (PPV) is approximately 2.4% for cancer. Studies have shown that nearly 60% of patients with a positive result have an actionable non-cancer finding under confirmatory colonoscopy.4 In the under 44 patient population, the sensitivity is 90.8%, specificity is 88.9%, the negative predictive value (NPV) is 75%, and the positive predictive value is approximately 96.3% for cancer. 3
Sensitivity Considerations
How should clinicians interpret concerns about the test’s sensitivity?
ColoHealth Direct LDT provides an option for patients who otherwise might not be screened. A screening test with lower sensitivity is better than not screening at all. Assuming reported adherence (rather than 100% adherence), a microsimulation study demonstrated a significant 37 cases averted per 1,000 screened and 23 when screened annually.5 Additional studies have shown that nearly 60% of patients with a positive result have clinically actionable findings on follow-up colonoscopy, including advanced adenomas and other gastrointestinal conditions.4
Polyp & Advanced Adenoma Detection
How does ColoHealth Direct LDT detect polyps?
Yes. In published studies, the mSEPT9 assay (ColoHealth Direct LDT) detected approximately 22% of advanced precancerous polyps, compared with 13.2% for Guardant Shield, indicating higher reported sensitivity for advanced precancerous lesions among blood-based screening tests. 4
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
Test Targets
What is the test looking for?
ColoHealth Direct LDT detects methylated Septin9 DNA shed into the bloodstream from tumors in the colorectum.
Patient Eligibility
Can the test be ordered for patients under 45 or high-risk patients?
The test is intended for 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.
Test Preparation
Do patients need to fast?
No fasting or special preparation is required prior to the blood draw.
Blood Draw Process
What does the blood drawing process look like?
Collect two (2) 10 mL K3 EDTA Cell Free DNA blood collection tubes.
Courier Service
Do we provide a courier service?
Yes, courier service is available locally. FedEx shipping is available nationwide.
Lab Location
Where is the lab located?
The lab headquarters is located at 2730 Cherokee Farms Way Ste. 300, Knoxville, TN 37920 and we have a growing network of labs nationwide.
Insurance Reimbursement
How will insurance reimbursement work?
New Day does not file insurance claims for patients.
Citations
1. 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.
2. 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.
3. 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.
4. Liles et al (2017) Uptake of a colorectal cancer screening blood test is higher than of a fecal test offered in a clinic: A randomized trial.
5. 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: Streamlined. Compliant. Patient-Centric.
Non-adherence remains a major hurdle in colorectal cancer screening. ColoHealth Direct provides a validated, blood-based alternative for patients who refuse colonoscopies or stool tests. By integrating this screening tool into your workflow, you can capture unscreened individuals and close critical gaps in preventative care. Contact our clinical support team today to establish a protocol for your practice or order test kits directly.