Notice
Korean IVD startup NGeneBio receives CE-IVD mark for next generation sequencing-based BRCA 1/2 test panel and clinical analysis software
Admin
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.”
About CE-IVD
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.
About NGeneBio
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