SEOUL, South Korea, June 4, 2023 /PRNewswire/ — Gencurix (KOSDAQ #229000), a leading provider of cancer molecular diagnostics, announced the release of clinical research results directly comparing the accuracy of its breast cancer prognostic test, GenesWell BCT, with Oncotype DX, the globally top-selling test, confirming its outstanding performance. The study, presented at the American Society of Clinical Oncology (ASCO), one of the world’s top three cancer conferences, on June 4th, attracted significant attention from breast cancer researchers worldwide.
This research is a follow-up to a study conducted in 2019 by five South Korean hospitals, including Samsung Medical Center, Asan Medical Center, National Cancer Center, Gangnam Severance Hospital, and Korea University Guro Hospital. While previous studies focused on comparing the concordance between the two testing methods, this research aimed to directly assess and compare prognostic performance through additional follow-up observations. In particular, the analysis evaluated which test accurately distinguished high-risk and low-risk groups based on actual cases of recurrence in patients, with a particular emphasis on patients under the age of 50, including premenopausal individuals which are frequently observed in Asian or other ethnic minority countries.
The study, conducted on a cohort of 759 patients who underwent follow-up observations, utilized Recurrence-Free Survival (RFS) as the primary evaluation variable. The results revealed that GenesWell BCT demonstrated a superior prognostic performance in accurately distinguishing high-risk and low-risk groups, with a Hazard Ratio of 2.469 for high-risk recurrence compared to 2.093 for OncotypeDX. This difference in favor of GenesWell BCT was even more pronounced in subgroup analyses based on lymph node metastasis. GenesWell BCT exhibited excellent prognostic performance regardless of lymph node involvement, while OncotypeDX did not show meaningful results in the subgroup analysis based on lymph node status.
Further detailed analysis focusing on patients classified as low-risk by OncotypeDX also confirmed the outstanding performance of GenesWell BCT. Even among patients classified as low-risk by OncotypeDX, GenesWell BCT identified a subset of high-risk patients who had a significantly higher risk of recurrence, indicating the need for consideration of adjuvant chemotherapy.
The treatment guidelines of the National Comprehensive Cancer Network (NCCN) in the United States recommend considering additional therapy, including chemotherapy, for some risk ranges (16-25 points) even for patients classified as low-risk (recurrence risk score ≤25 points) by OncotypeDX in the case of patients under the age of 50. In contrast, GenesWell BCT has demonstrated its clinical effectiveness in predicting prognosis, including for patients under the age of 50, through this research.
Dr. Moon, Chief Technology Officer at Gencurix, stated, "The study that directly compared GenesWell BCT with the globally recognized top-selling test OncotypeDX, through actual follow-up observations, has provided solid data to demonstrate the excellent performance of GenesWell BCT. This has generated significant interest among breast cancer researchers attending ASCO. Particularly, the performance of GenesWell BCT in the younger population, including patients under the age of 50, holds great significance in countries with diverse ethnicities where premenopausal breast cancer patients account for over 50%."
In Korea, GenesWell BCT is already being adopted by numerous comprehensive hospitals as a replacement for existing tests. In April, the clinical results of a 15-year follow-up study on breast cancer patients in Korea and Japan, conducted in collaboration with Sagara Hospital in Japan and Asan Medical Center, were also announced at Global Breast Cancer Conference 2023(GBCC).
The promising findings from the comparative study have further solidified the position of GenesWell BCT as an advanced breast cancer prognostic test with enhanced accuracy, providing healthcare professionals with a reliable tool to make informed treatment decisions.
Gencurix (KOSDAQ #229000) is a leading provider of cancer molecular diagnostics, dedicated to developing innovative solutions that improve patient outcomes. Committed to research and development, Gencurix strives to address unmet needs in cancer diagnosis and treatment, ultimately revolutionizing the field of precision medicine. For more information, visit www.gencurix.com.
Source: Gencurix Announces Clinical Research Results At ASCO 2023 Demonstrating Outstanding Performance of GenesWell BCT, the Company's Breast Cancer Prognostic Test, Compared to Global Best-Selling Test, OncotypeDX