Genomictree's EarlyTect Colorectal and Bladder Cancer Tests Simultaneously Obtain European CE-IVDR Certification

Genomictree (CEO Sungwhan Ahn) announced on January 12 that its early cancer detection products, EarlyTect-C (colorectal cancer) and EarlyTect-B (bladder cancer), have simultaneously obtained CE-IVDR certification, the European in vitro diagnostic medical device regulation.

CE-IVDR, an essential gateway for entering the European market, is the latest regulation that significantly strengthens clinical evidence and quality management standards compared to the previous guideline (IVDD). In particular, the legal requirements for in vitro molecular cancer diagnostics have become much stricter, meaning that only companies with world-class technological capabilities can meet these standards. Through this certification, Genomictree has demonstrated both the global credibility and entry barriers of its molecular cancer diagnostic technology, laying the foundation for commercialization in the European diagnostics market.

EarlyTect-C, which has obtained certification, is a product that diagnoses colorectal cancer with high sensitivity by measuring the methylation status of syndecan-2 (SDC2), a colorectal cancer biomarker, in stool DNA. In addition, EarlyTect-B is an innovative liquid biopsy product for cancer diagnosis that detects the methylation of the PENK gene, a bladder cancer biomarker, in urine DNA to determine the presence of cancer.

Both products have received manufacturing approval from the Ministry of Food and Drug Safety in Korea and are currently being actively used to provide diagnostic services at major hospitals and screening centers in Korea. These proven commercialization achievements in the domestic market are expected to serve as a key asset for enhancing product credibility during the process of entering the European market.

Yongwoon Lee, Head of Business Division at Genomictree, stated, "Meeting this regulation will be an important turning point for expanding our business across Europe, following our recent colorectal cancer diagnostic service contract in the United Kingdom. In particular, the bladder cancer diagnostic product can be supplied directly as a diagnostic kit to hospitals, clinical laboratories, and health screening centers, which is advantageous in terms of market scalability."

He added, "Based on the test performance proven in Korea and the CE-IVDR certification, we will rapidly implement our sales strategy in the European market to achieve visible global revenue results."

Meanwhile, Genomictree is leading the popularization of early cancer detection with its proprietary biomarker-based technology, and with this certification, the company plans to further solidify its global position in the biomarker-based liquid biopsy market for early cancer detection.