NgenBio Obtains European In Vitro Diagnostic Certification for Solid Tumor Precision Diagnostic 'OncoAcuPanel'

[Asia Economy Reporter Lee Gwan-joo] NGENBIO announced on the 3rd that it has obtained the European CE-IVD certification for its next-generation sequencing (NGS)-based large-scale solid tumor precision diagnostic product, 'ONCOaccuPanel.'

ONCOaccuPanel is a large-scale solid tumor precision diagnostic product that simultaneously tests mutations in over 300 genes related to 35 types of cancers, including lung cancer, colorectal cancer, stomach cancer, and breast cancer, providing optimal targeted anticancer drug information for personalized treatment.

This is the fifth CE-IVD certification obtained by NGENBIO for its NGS products, following those for breast cancer, hematologic cancer, solid tumors, and HLA products. In South Korea, the company applied for a Class 3 in vitro diagnostic medical device approval from the Ministry of Food and Drug Safety last month, and the review is currently underway.

ONCOaccuPanel was jointly developed by Seoul Asan Medical Center and Harvard University's Dana-Farber Cancer Institute, and NGENBIO licensed the technology to launch the product. Its clinical utility has been confirmed through analysis of specimens from more than 10,000 cancer patients in domestic clinical settings.

Choi Dae-chul, CEO of NGENBIO, said, “With the European CE-IVD certification of ONCOaccuPanel, we can provide a verified solid tumor product to the high-demand European and Asian markets. As demand for NGS cancer testing is increasing, evaluation tests for ONCOaccuPanel are already underway in several European countries including Poland, and we expect this to play a significant role in expanding overseas sales.”

This content was produced with the assistance of AI translation services.