SEOUL, South Korea, July 6, 2017 /PRNewswire/ — Molecular diagnostics startup NGeneBio Co., Ltd. of Korea has received CE-marking for next generation sequencing (NGS)-based in vitro diagnostics (IVD) products, BRCAaccuTestTM and clinical analysis software, NGeneAnalySysTM for hereditary breast/ovarian cancer genetic testing (30/Jun).
BRCAaccuTestTM is an amplicon-based targeted NGS panel which detects germline mutations in BRCA1 and BRCA2 genes for breast/ovarian cancer patients and genetic predisposition.
NGeneAnalySysTM, 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 BRCAaccuTestTM. 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 BRCAaccuTestTM (class III) in combination with NGeneAnalySysTM (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, NGeneAnalySysTM 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, CEO of NGeneBio stated, “It is expected that CE-IVD marking of BRCAaccuTestTM and NGeneAnalySysTMwill 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.”
CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC), and that the device may be legally commercialized in the EU.
NGeneBio Co., Ltd. is a leading company in molecular diagnostics (MDx) and companion diagnostics (CDx), which develops and provides next generation sequencing (NGS)-based in vitro diagnostics (IVD) panel and clinical analysis software (SW).
NGeneBio was founded in October 2015, headquartered in Seoul, South Korea as a joint venture between Genecurix and Korea Telecom. The company launched NGS-based hereditary breast/ovarian cancer panel (BRCAaccuTestTM) with clinical analysis SW (NGeneAnalysisTM) in 2016. BRCA NGS panel for PARP inhibitor CDx test and solid tumor/hematologic cancer NGS panels will be launched, inclusive of clinical data analysis SW platform. The mission of the company is to provide clinically validated NGS based IVD/CDx products/services with convergence of innovative bioinformatics and SW development capacity for global market. For more information, visit www.ngenebio.com