NGeneBio of Korea, a leading company in molecular diagnostics and companion diagnostics, has received CE-marking for next generation sequencing (NGS)-based in vitro diagnostics (IVD) products, BRCAaccuTest and clinical analysis software, NGeneAnalySys for hereditary breast/ovarian cancer genetic testing (30/Jun).
BRCAaccuTest is an amplicon-based targeted NGS panel which detects germline mutations in BRCA1 and BRCA2 genes for breast/ovarian cancer patients and genetic predisposition.
NGeneAnalySys, a fully-functioning NGS data analysis SW platform for quality control and clinical report generation solutions, has been CE-registered also for combined use with BRCAaccuTest. It has been developed originally and exclusively by NGeneBio.
NGeneBio has become the first Asian company to obtain a CE-IVD marking for the clinical use of NGS panel and analysis SW, on Illumina NGS platform.
The company is conducting clinical validation for Korean Ministry of Food and Drug Safety (MFDS) IVD approval of BRCAaccuTest (class III) in combination with NGeneAnalySys (class II), which are the first NGS based kit and data analysis SW entered IVD approval process in Korea.
NGeneBio is developing NGS-based BRCA test for tumor tissue from ovarian cancer patients, as a companion diagnostic test for treatment with PARP inhibitor, BRCA mutated tumor-targeted therapy. Solid tumors/hematologic cancer NGS panels will be launched by end of 2017. All the NGS-based diagnostic kits will include a proprietary SW platform tool, NGeneAnalySys which ensures convenient data analysis, quality control and clinical-grade report generation enabling clinical laboratories to guarantee validated molecular test for relevant mutations and therapy information.
Daechul Choi, chief executive officer of NGeneBio stated, "It is expected that CE-IVD marking of BRCAaccuTest and NGeneAnalySys will be followed by Korean MFDS IVD approval this year, based on clinical validation data. We are planning to launch NGS-IVD kit and clinical analysis SW in international markets such as Europe, China, and Southeast Asian countries with competencies in clinical validated quality and reliability."