Genomictree Signs Supply Agreement with UK’s EDX Medical for EarlyTect-C Colorectal Cancer Diagnostic Test

Genomictree (CEO Ahn Seonghwan) announced on December 4 that it has signed a service supply agreement for its colorectal cancer molecular diagnostic test, 'EarlyTect-C,' with EDX Medical Ltd., a UK-based digital diagnostics specialist.

Through this agreement, Genomictree has secured a foundation for immediate commercial sales in the UK market. This milestone also significantly increases the potential for expansion across the broader European market, including Northern Europe.

Since Brexit, the UK has maintained its existing IVDD system rather than adopting the EU's CE-IVDR regulations. Genomictree has completed the registration of the EarlyTect-C collection kit with the UK Medicines and Healthcare products Regulatory Agency (MHRA), enabling product sales in the UK without any additional certification process. The company highlighted that this allows for the immediate commercialization of the product in the UK, which is one of the fastest entry points among European markets.

Colorectal cancer is the second leading cause of cancer-related deaths in Europe. According to the European Cancer Inequalities Registry (ECIR), there were approximately 361,986 new cases and 161,182 deaths from colorectal cancer in Europe in 2022. These figures underscore the growing importance of accurate, non-invasive diagnostic methods for colorectal cancer.

In particular, the UK and Northern European countries have some of the highest rates of colorectal cancer worldwide, and demand for highly reliable testing continues to rise. Existing FIT and FOBT-based screening tests face structural limitations such as low sensitivity, false positives, and bottlenecks caused by surging demand for invasive colonoscopies. As a result, there has been a consistent need for more accurate and non-invasive molecular diagnostic tests. EDX Medical has announced plans to meet these medical needs in the region by introducing EarlyTect-C.

This supply agreement is not limited to the UK market. Leveraging EDX Medical's network in Scandinavia, it lays the groundwork for expanding supply to Northern European countries. Furthermore, once Genomictree completes the CE-IVDR certification for EarlyTect-C, the company expects to expand its supply across the entire EU, using the UK and Northern European markets as a springboard. Genomictree also anticipates that building out this distribution and data infrastructure will facilitate the faster entry of its subsequent products, such as the EarlyTect-BC bladder cancer test, into the European market.

Lee Yongwoon, Head of Business Division at Genomictree, stated, "This supply agreement enables us to begin immediate sales in the UK and makes expansion into Northern and broader European markets much easier. Starting with our colorectal cancer testing service, we will continue to prepare so that our subsequent products, including bladder cancer diagnostics, can secure competitiveness in the European market."