Creating a New Day where early detection and preventative diagnostics are simple, affordable, and accessible for all
Addressing Critical Gaps in Screening and Development
Despite advances in medicine, many high-impact diseases still lack non-invasive, accessible screening tools, leading to late diagnosis and poor outcomes. Concurrently, the path to bringing new diagnostics to market is often fragmented and complex. New Day Diagnostics bridges these gaps by offering proprietary technology and specialized R&D partnership services.
ColoHealth - Solving the Screening Problem
Traditional screening methods (like colonoscopy for CRC) are often invasive, costly, or require extensive preparation, leading to low patient compliance and delayed diagnoses.
Our Solution: ColoHealth provides a highly accurate, non-invasive, blood-based diagnostic test that removes the most significant compliance barriers. This makes life-saving early detection simple, convenient, and accessible to a broader population, improving adherence to screening guidelines.
Validated Science. Operational Excellence. Trusted Partnership.
Developing and validating a new diagnostic test—from biomarker discovery through clinical trials and regulatory approval—requires specialized expertise often unavailable in-house, leading to costly delays and project failure.
Our Solution: New Day CRO Services team is comprised of diagnostic specialists with deep experience in assay development, clinical trial management, and regulatory strategy. We offer end-to-end partnership to accelerate the path from concept to commercialization for novel diagnostic technologies.
About New Day Diagnostics
Validated Science. Operational Excellence. Trusted Partnership.
Our commitment to advancing diagnostics is built on a foundation of rigorous clinical validation, adherence to the highest regulatory standards, and established operational excellence.
Vision
Creating a New Day where early detection and preventative diagnostics are simple, affordable, and accessible for all
MISSION
To end colorectal cancer as a leading cause of death by making screening as easy as a routine blood draw
10 YEAR AUDACIOUS GOAL
Become a universal Liquid Biopsy platform for detecting many major cancers through routine blood draw. Reduce colorectal cancer mortality globally through significant increase in screening adherence with a first-line blood test
Proven Accuracy: Validated by 99.7% NPV
ColoHealth is not just convenient—it is backed by robust, peer-reviewed clinical data. In studies comparing our test to current screening standards, ColoHealth demonstrated a Negative Predictive Value (NPV) of 99.7%, providing patients and physicians with high confidence in a negative result. This proven accuracy, combined with a simple, non-invasive blood sample, drastically improves screening compliance, ensuring more patients receive life-saving early detection.
Operational Excellence: CLIA and ISO 13485 Certified
Our Contract Research Organization (CRO) services and central laboratory operate under the highest global standards for quality management. We maintain CLIA certification for high-complexity testing and are ISO 13485:2016 certified for the design, development, and provision of diagnostic devices. This compliance provides our partners and investors with assurance that all clinical trial testing, sample processing, and diagnostic assay validation are conducted with documented rigor, precision, and adherence to critical regulatory pathways.
Accelerated Growth Through Strategic Alliances
New Day Diagnostics is rapidly expanding its commercial footprint and pipeline through targeted strategic alliances. Recent milestones include the merger with EDP Biotech, creating a vertically integrated diagnostics powerhouse, and the binding LOI with Hepion Pharmaceuticals to commercialize tests for Celiac Disease and H. pylori. Furthermore, our partnership with SehaMed Global is launching ColoHealth distribution across the Middle East, confirming our ability to execute on a global commercial strategy and enter high-growth international markets.
The Future of Diagnostics: Our Expanding Pipeline
Our mission, TRANSFORMING ACCESS TO HEALTH INFORMATION, extends well beyond colorectal cancer screening. We are continuously leveraging our core technology and integrated development platform to tackle major unmet needs across critical disease states, ensuring that patients receive affordable, convenient, and early-stage diagnoses for a better future.
- Oncology: Expanding early detection to include assays for prostate cancer.
- Digestive Disease: Developing crucial non-invasive tests.
- Infectious Disease: Creating multiplex assays for efficient detection of common respiratory threats, including COVID-Flu-RSV.
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