Gencurix Publishes A Clinical Validation Study On GenesWell BCT, A New Breast Cancer Prognostic Test

SEOUL, South Korea--(BUSINESS WIRE)--On 28 March, Gencurix (KONEX:229000) announced that the results of clinical trials for the prediction of breast cancer prognosis were published in Scientific Reports, which is affiliated with the prestigious journal, Nature.

“It is of great significance to have objectively proved that the algorithm for predicting the prognosis of breast cancer developed by using Samsung Medical Center clinical sample can be clinically applicable to the diagnosis of the prognosis of the target patients through the clinical trial in Asan Medical Center, Seoul.”

The study, entitled “A new molecular prognostic score for predicting the risk of distant metastasis in patients with HR+/HER2- early breast cancer,” showed that GenesWell BCT classifies early breast cancer patients into high-risk group and low risk group according to the risk of distant metastasis. Patients classified as low risk group have a very low probability of distant metastasis within 10 years without chemotherapy while patients classified as high risk group have a high probability. Moreover, GenesWell BCT has a prognostic power superior to that of prognostic model based on clinicopathological parameters. Researchers led by Seoul National University’s Young Kee Shin further reported that GenesWell BCT may help guide decisions about the need for additional adjuvant therapies in patients with early breast cancer.

GenesWell BCT is a breast cancer prognostic test that was developed to identify early breast cancer patients (stage I or stage II) who don’t need chemotherapy. GenesWell BCT is intended for application to early breast cancer patients who are hormone receptor positive (ER/PR+) and human epidermal growth factor receptor negative (HER2-) with metastasis involving fewer than three lymph nodes and who did not receive preoperative chemotherapy.

The test differentiates between low-risk patients with high survival rate without chemotherapy and high-risk patients with low survival rate without chemotherapy by providing probability of distant metastasis-free survival by analyzing RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissues of early breast cancer patients. It includes a total of nine genes: five proliferation genes, one immune gene and three reference genes.

“It is of great significance to have objectively proved that the algorithm for predicting the prognosis of breast cancer developed by using Samsung Medical Center clinical sample can be clinically applicable to the diagnosis of the prognosis of the target patients through the clinical trial in Asan Medical Center, Seoul.” Youngho Moon, CTO of Gencurix, said in a statement announcing the publication of the trial results. “Also GenesWell BCT provides more accurate prognostic assessments than clinical factor-based prognostic predictors for early breast cancer patients.” he added.

Since its foundation as a biotechnology company, Gencurix has been committed to the advances of molecular diagnostics with accumulating R&D capacity and product development. The first prognostic test of early breast cancer in Korea, GenesWell BCT was approved (Class III) by Ministry of Food and Drug Safety last year.

Sang Rae Cho, CEO of Gencurix, said “GenesWell BCT is expected to be a clinically useful tool for detecting the likelihood of late metastasis as well as early metastasis and help physicians decide on the best course of treatment.” He also announced the future plan saying that “We are planning to submit a 510(k) application to get US FDA clearance and prepare for prospective clinical trial in Asia such as Korea, China, Japan and Southeast Asian countries.”

About Gencurix

Gencurix Inc. is a leading molecular diagnostics company in Korea, which discovers and develops molecular diagnostic products to provide physicians with the result of a patient’s gene analysis for cancer treatment.

Gencurix offers its GenesWell BCT as a prognostic diagnostic test for early breast cancer patients with HR+, HER2- and pN0/1, where it analyzes the expression levels of 9 genes in FFPE samples and derives BCT score to assess a patient’s individual risk for distant metastasis within 10 years after surgery (Low risk group& High risk group). The GenesWell ddEGFR Mutation Test is a ddPCR-based companion diagnostic test for non-small cell lung cancer (NSCLC) patients, which offers the qualitative and Quantitative detection and identification of 46 mutations in exon 18, 19, 20 and 21 of EGFR genes. GenesWell ddRAS/BRAF Mutation Test is also a companion diagnostic test the company offers. It detects a total of 32 mutation sites of KRAS, NRAS, BRAF genes for colorectal cancer patients. These tests guide treatment decisions regarding optimal anti-cancer treatment for each patient in order to improve patient care.

In addition Gencurix has pipelines of other molecular diagnostic products in development for various types of cancer using not only FFPE but also cfDNA from bloodstream. Also the company collaborates with diagnostic companies, leading cancer centers and academic groups to commercialize molecular diagnostic tests based on NGS (Next Generation Sequencing) and CTC (Circulating Tumor Cell) detection. For more information, visit www.gencurix.com.