바이오스펙테이터

by Yoonseok Suh

[ASCO 2024]Colorectal cancer diagnostic technology 'COLO eDX' for potential use in recurrence monitoring after primary treatment and a validation of the high sensitivity detection performa

On April 3, Gencurix is poised to unveil the outcomes of two clinical studies on colorectal cancer at the American Society of Clinical Oncology (ASCO) annual meeting.

Scheduled from May 31 to June 4, 2024, in Chicago, USA, the ASCO annual meeting is one of the world’s leading cancer conference, alongside the American Association for Cancer Research (AACR) and the European Society for Medical Oncology (ESMO).

At this meeting, Gencurix will announce two significant research results related to colorectal cancer. The first is a clinical evaluation of an early stage colorectal cancer diagnostic technology, 'COLO eDX,' for minimal residual disease (MRD), and the second is a validation of the high sensitivity detection performance of the 'Droplex Mutation Test,' a companion diagnostic technology targeting key genetic mutations (KRAS, NRAS, BRAF) in colorectal cancer.

The COLO eDX is a blood-based test that detects colorectal cancer-specific biomarkers to determine the presence of colorectal cancer via digital PCR. This assay not only aims for early diagnosis of colorectal cancer but also explores its potential use in recurrence monitoring after primary treatment. Gencurix previously presented the development and validation results of COLO eDX biomarkers along with small-scale clinical trial results at the AACR in 2023, and now they are disclosing the results of expanded clinical studies.

In addition, Gencurix's Droplex Mutation Test is designed to identify patients eligible for targeted therapy based on sensitive detection of cancer-specific mutations through digital PCR. This research aimed to establish that 'KRAS, NRAS, and BRAF Droplex Mutation Tests' are capable of analyzing not just conventional cancer tissue samples but also blood specimens from individuals with colorectal cancer.

Jinil Han, Director of Research and Development at Gencurix, remarked, "Leveraging unparalleled detection sensitivity offered by digital PCR technology combined with our exclusive biomarker development expertise, we are now equipped to provide tailored liquid biopsy testing services for patients with colorectal cancer. We expect that our presentation at this year's ASCO will reinforce Gencurix's preeminent position in the field of liquid biopsy-based in vitro diagnostic medical devices."

▲COLO eDX(left), Droplex