New Day Diagnostics

Executive Summary

New Day Diagnostics is a private, early-stage diagnostics company founded in 2018 and headquartered in San Diego, CA, with a major operational site in Knoxville, TN. The company is dedicated to transforming healthcare access by developing and commercializing reliable, early-stage diagnostic tests that are affordable and convenient. Its initial focus is on ending colorectal cancer as a leading cause of death through a novel blood-based screening test, with a long-term vision to expand into a universal liquid biopsy platform covering multiple major cancers. By prioritizing accessibility and early detection, New Day Diagnostics aims to address significant unmet needs in cancer screening, particularly among underserved populations who may avoid traditional colonoscopy. The company leverages its proprietary technology to deliver high-accuracy results from a simple blood draw, potentially increasing screening compliance and reducing mortality. While still in the pre-revenue stage and without publicly disclosed funding rounds, New Day Diagnostics has established a strong foundational team and operational infrastructure to advance its pipeline toward clinical validation and regulatory approval. The company operates in a highly competitive landscape dominated by established players like Exact Sciences (Cologuard) and Guardant Health, as well as emerging liquid biopsy firms. However, New Day Diagnostics differentiates itself through a focus on affordability and convenience, targeting both clinical and at-home testing settings. Key near-term milestones include completing pivotal clinical studies for its colorectal cancer test, securing FDA approval or CLIA waiver, and initiating commercial partnerships for distribution. If successful, the company could capture a significant share of the multi-billion-dollar cancer screening market, particularly in the colorectal segment where compliance remains low. The upcoming catalysts will be critical in validating its technology and de-risking the investment thesis.

Upcoming Catalysts (preview)

• Q3 2026Pivotal clinical trial results for colorectal cancer blood test70% success
• Q4 2026FDA submission or 510(k) clearance for colorectal cancer screening test60% success
• Q2 2026Strategic partnership or licensing agreement for commercialization50% success