Existing FDA-approved blood test for colorectal cancer screening, ColoHealth™, formerly known as Epi proColon.
ColoHealth™ has been on the market since 2016 as the first and only FDA-approved blood test for colorectal cancer screening. Recently rebranded by New Day Diagnostics, ColoHealth™ detects cancer signals in the bloodstream from blood plasma samples. This marks a significant advancement in colorectal cancer screening by providing a non-invasive option that does not require stool handling or special pretest preparation.
Here are some key points and benefits of ColoHealth™ compared to other screening options:
Highlights, Key Points, and Benefits of ColoHealth™[1]: The Only FDA-Approved Blood Test for Colorectal Cancer Screening
ColoHealth™ detects cancer signals in the bloodstream from blood plasma samples, this marks a significant advancement in colorectal cancer screening by providing a non-invasive option that does not require stool handling or special pretest preparation. ColoHealth™ is indicated for people at average risk of developing colorectal cancer, aged 50 and older, who have declined colonoscopy and stool-based screening options.
Here are some key points and benefits of ColoHealth™ compared to other screening options:
1. Proven Track Record: ColoHealth™ (formerly marketed as “Epi proColon”) was FDA-approved and has been widely available since 2016 [2].
2. High Adherence Rates: In a clinical trial, adherence rates for the Epi proColon blood test were 99.5% among subjects who had twice refused other recommended screening options. This is a significant achievement in increasing screening compliance [3].
3. Advanced Detection: ColoHealth™ demonstrates superior performance in advanced adenoma detection with a rate of 21.5% [4].
4. Significant Impact: The ColoHealth™ biomarker SEPT9 contributes to reducing colorectal cancer cases and deaths, a micro-simulation study illustrated 37 cases averted per 1,000 screened and 23 deaths averted per 1,000 screened when screened annually. These numbers highlight the life-saving potential of early detection [5].
5. Effective for Early-Onset CRC: A small, retrospective, clinical trial demonstrated the ColoHealth™ biomarker mSEPT9 is a sensitive and specific biomarker in detecting early-onset colorectal cancer (EOCRC) in individuals under 50, with sensitivity and specificity rates of 90.8% and 88.9%, respectively [6].
6. Affordability: At approximately $199, ColoHealth™ is an affordable screening option for those who cannot or will not use more invasive procedures [7].
7. Accuracy and Reliability: With a sensitivity of 73.3%, a specificity of 81.5% and negative predictive value (NPV) of 99.8%, ColoHealth offers assurance to those who test negative.[4,8].
8. Adherence Impact: According to current recommendations by the US Preventive Services Task Force (USPSTF), adherence rates significantly impact the effectiveness of colorectal cancer screening strategies. ColoHealth™ provides a valuable option with higher adherence rates compared to traditional methods, thereby potentially reducing colorectal cancer incidence and mortality more effectively [5, 9].
We applaud the development of new screening options like Guardant, as our ultimate goal at New Day Diagnostics is to save lives through early detection. However, it is crucial to recognize that ColoHealth™ is already a proven and reliable FDA-approved option available to those who need it now. We are committed to providing accessible and effective screening options to reduce the impact of colorectal cancer.
[1] All clinical trial data and journal articles referenced concern Epi proColon, the FDA-approved blood test for colorectal cancer screening. New Day Diagnostics has acquired and rebranded this test as ColoHealth™. The company is currently transferring the FDA approval to the ColoHealth™ brand, with completion expected in 2024.
[2] Gerbil, A., ‘FDA Approves Epigenomics AG’s Colorectal Cancer Screening Blood Test’, Epigenomics AG, 2024.
[3] Wu, T., Shao, J., Gu, X., Ng, M. K., & Zeng, T. “The role of epigenetics in the development of colorectal cancer.” Journal of Advanced Research, vol. 7, no. 5, 2016, pp. 675-684. ScienceDirect, doi:10.1016/j.jare.2016.01.001.
[4] Johnson DA, Barclay RL, Mergener K, Weiss G, Ko ̈nig T, et al.” Plasma Septin9 versus Fecal Immunochemical Testing for Colorectal Cancer Screening: A Prospective Multicenter Study.” PLoS ONE 9(6): e98238. 2014 doi:10.1371/journal.pone.0098238
[5] D’Andrea, E., Ahnen, D., Sussman, D., Najafzadeh, “Quantifying the impact of adherence to screening strategies on colorectal cancer incidence and mortality.” Cancer Medicine, Volume 9, Issue 2, 2019, pages 824-836. https://doi.org/10.1002/cam4.2735 [Accessed 29 July 2024].
[6] Loomans and-Krupp, H., Song, Y., Gala, M., Parikh, A., Seventer, E. And others “Methylated Septin9 (mSEPT9): A promising blood-based biomarker for the detection and screening of early-onset colorectal cancer.” Cancer Res Commun., Volume 2, Issue 2, 2002, pages 90-98. https://doi.org/10.1158/2767-9764.CRC-21-0142 [Accessed 29 July 2024].
[7] Myers, D., “Are There Finaincial Assistance Programs for Colon Cancer Screening?” Very well Health (2024) https://www.verywellhealth.com/colon-cancer-screening-for-the-uninsured-797587#:~:text=On%20average%2C%20the%20line%20items%20costs%20for%20the,to%20%243%2C750%206%20Conventional%20colonoscopy%3A%20%242%2C000%20to%20%243%2C750
[8] Potter, N., Hurban, P., White, M., Whitlock, C. And others, “Validation of a Real-Time PCR-Based Qualitative Assay for the Detection of Methylated SEPT9 DNA in Human Plasma.” Clinical Chemistry, Volume 60, Issue 9, 1 September 2014, Pages 1183-1191, https://doi.org/10.1373/clinchem.2013.221044 [Accessed 29 July 2024].
[9] Liles, E., Coronado, G., Perrin, N., Howell Harte, A., Nungesser, R., and others “Uptake of a colorectal cancer screening blood test is higher than of a fecal test offered in clinic: A randomized trial.” Cancer Treatment and Research Communications, Volume 10, 2017, Pages 27-31, https://doi.org/10.1016/j.ctarc.2016.12.004 [Accessed 29 July 2024].