Universal Diagnostics has announced the closure of its Series B funding round, which was initiated to fund clinical trials of its Signal-C colorectal cancer blood screening test. With the funding requirement met, the company is set to begin clinical trials in order to gain premarket approval from the US FDA for the treatment.

The treatment works by leveraging next-generation sequencing (NGS) and bioinformatics to identify methylated DNA patterns and fragments shed by colorectal cancer tumors circulating in the bloodstream. Clinical trials for Signal-C commenced at the beginning of 2024, recruiting its first patient in January. The current recruiting goal for the program is to enroll a minimum of 15,000 patients across 100 investigator sites. 

Universal Diagnostics is a bioinformatics and multi-omics company focused on developing early cancer detection technologies. The company employs a combination of cell-free DNA (cfDNA) methylation, fragmentation, and microbiome analysis coupled with advanced computational biology and ML algorithms to identify cancer signals. Its primary product, Signal-C, is a single-draw blood test designed to detect colorectal cancer with high accuracy, particularly in early stages. 

Analyst QuickTake: The Series B funding round of Universal Diagnostics was first announced in November 2023 , raising EUR 64.2 million (~USD 70.6 million), with participation from Quest Diagnostics. Universal Diagnostics simultaneously entered a strategic partnership with Quest Diagnostics granting the latter the rights to exclusively offer United Diagnostics’s Signal-C colorectal cancer screening test in the US.