Gencurix Publishes a Clinical Validation Study on GenesWell BCT, a New Breast Cancer Prognostic Test

SEOUL, South Korea–(BUSINESS WIRE)–#Gencurix–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.

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
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

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


Eungjo Park, 82-10-9093-0071