GenesWell® BCT

Gencurix, Inc.

Seoul, South Korea

Company Overview Gencurix is dedicated to advancing precision oncology through biomarker-based molecular diagnostics that enable patient-specific treatment selection and prognosis prediction. Leveraging clinically proven biomarkers and digital PCR (dPCR) technology, we develop accurate, rapid, and accessible diagnostic solutions addressing unmet medical needs. Our focus areas include liquid biopsy diagnostics , companion diagnostics (CDx) , minimal residual disease (MRD) testing , and early cancer detection . We collaborate with global pharmaceutical companies and technology partners to develop regionally optimized diagnostic products. Our products have received KR-MFDS and CE-IVDD approvals and are undergoing CE-IVDR and US FDA processes. Key Products 1. Droplex® Series Comprehensive gene mutation tests using digital PCR for targeted cancer therapy. The Droplex platform provides a fast, cost-effective, and decentralized alternative to NGS, supporting both tissue (FFPET) and liquid biopsy (cfDNA) samples. It delivers clinically validated mutations with high sensitivity and short turnaround time—ideal for real-world clinical settings. -Droplex EGFR Mutation Test v2 (NSCLC) Detects key EGFR mutations (exon 19 deletions, L858R, T790M, exon 20 insertions, C797S/G, G794S, L718Q/V) supporting the use of EGFR-TKI ( Erlotinib and Osimertinib) . Approved by KR-MFDS (2023) and CE-IVDD (2022). -Droplex PIK3CA ESR1 Mutation Tests (Breast Cancer) Identify mutations driving hormone therapy resistance in HR+ breast cancer, supporting the use of PI3K inhibitors ( Alpelisib, Capivasertib, Inavolisib ) and SERD therapies ( Elacestrant, Camizestrant ). -Other Assays: KRAS (Colorectal), BRAF (Thyroid), POLE (Endometrial), cMET Exon 14 (NSCLC). 2. GenesWell™ BCT A gene expression-based prognostic test for HR+, HER2- early breast cancer , predicting 10-year distant metastasis risk and chemotherapy benefit , supporting personalized treatment decisions. 3. GenoCTC™ Platform An advanced circulating tumor cell (CTC) isolation system using magnetophoresis and microfluidic technology . Provides high-purity CTC capture for liquid biopsy , metastasis monitoring , and precision oncology research . Regulatory Status: KR-MFDS (Approved), CE-IVDD (Approved), CE-IVDR (In progress), US FDA (In progress) Core Technologies: Digital PCR, Liquid Biopsy, Molecular Diagnostics, Companion Diagnostics, Biomarker Discovery.