Knoxville, TN – March 27, 2026 – In recognition of Colorectal Cancer Awareness Month, New Day Diagnostics is drawing attention to the alarming rise in early-onset colorectal cancer (EOCRC) and the urgent need for accessible, affordable screening solutions for the general public.
Colorectal cancer remains one of the leading causes of cancer-related death in the United States. While screening has reduced incidence among adults over age 50, diagnoses in individuals under 50 continue to increase at concerning rates globally. Many of these younger individuals fall outside traditional screening pathways, creating a growing public health gap.
A peer-reviewed study published in Cancer Research Communications evaluated the blood-based biomarker methylated Septin9 (mSEPT9) in individuals under age 50 diagnosed with colorectal cancer. The study demonstrated 90.8% sensitivity and 88.9% specificity, with an area under the curve (AUC) of 0.89, highlighting strong performance in distinguishing colorectal cancer from healthy controls. Importantly, mSEPT9 positivity was detected in 88.9% of early-onset cases studied while remaining low in healthy individuals under 50.1
These findings reinforce the potential role of blood-based screening as a scalable, minimally invasive approach to help address rising early-onset disease rates and screening limitations related to cost, capacity, and patient reluctance toward colonoscopy or stool-based testing.
New Day Diagnostics’ ColoHealth Direct™ solution is a laboratory developed test (LDT) detecting mSEPT9, designed to help expand access to colorectal cancer screening through an affordable, convenient blood-based option. The LDT test requires only a standard blood draw and does not involve bowel preparation or stool handling, lowering barriers that often prevent individuals from completing screening. This new and improved direct-to-patient LDT testing solution is based on the original FDA-Approved ColoHealth™ mSEPT9.
“Early detection can save lives, especially as colorectal cancer increasingly affects younger adults,” said Eric Mayer, CEO of New Day Diagnostics. “Our mission is to provide practical, accessible tools that empower patients and providers to close the screening gap and identify disease earlier.”
“Doctors appreciate the test because it has already increased access for patients in East Tennessee with limited resources,” said Dr. Melissa Chiles, Medical Director at New Day Diagnostics.
“ColoHealth has allowed me to offer a convenient, in-office alternative that removes many of the barriers that keep people from getting screened,” Chiles said in a statement.
As Colorectal Cancer Awareness Month underscores the need for prevention and early detection, New Day Diagnostics encourages adults to speak with their healthcare providers about appropriate screening options. ColoHealth Direct is available by prescription, subject to eligibility determinations by a provider, at ColoHealthy.com
ABOUT NEW DAY DIAGNOSTICS
New Day Diagnostics is a clinical diagnostics company committed to advancing innovative, accessible cancer screening technologies. Through development and commercialization of blood-based biomarker solutions, the company aims to expand early detection and improve patient outcomes nationwide.
References
1.Loomans-Kropp HA, et al. Methylated Septin9 (mSEPT9): A Promising Blood-Based Biomarker for the Detection and Screening of Early-Onset Colorectal Cancer. Cancer Research Communications. 2022. DOI: 10.1158/2767-9764.CRC-21-0142
