NGeneBio Co., Ltd of Seoul at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
Manufacturers

NGeneBio Co., Ltd

1104, Hanhwa Bizmetro, 242, Digital-ro, Guro-gu, 08394 Seoul
Korea, Republic

Telephone +82 2 8679798
Fax +82 2 8839784
business@ngenebio.com

This company is co-exhibitor of
Korea Medical Devices Industrial Coop. Association (KMDICA)

Hall map

MEDICA 2017 hall map (Hall 16): stand C59

Fairground map

MEDICA 2017 fairground map: Hall 16

Contact

Lukas Lee

International Business Team Manager

Phone
+82 10 9255 3678

Email
lukas@ngenebio.com

Youngjoon Moon

Director, Business Development Division

Phone
+82 10 5555 1336

Email
yj.moon@ngenebio.com

Our range of products

Product categories

  • 03  Diagnostics
  • 03.01  Clinical chemistry
  • 03.01.07  Gene tests / molecular biological diagnostic

Gene tests / molecular biological diagnostic

  • 03  Diagnostics
  • 03.01  Clinical chemistry
  • 03.01.07  Gene tests / molecular biological diagnostic
  • 03.01.07.02  DNA analysis

DNA analysis

  • 03  Diagnostics
  • 03.01  Clinical chemistry
  • 03.01.07  Gene tests / molecular biological diagnostic
  • 03.01.07.03  DNA sequencing

DNA sequencing

Company news

Date

Topic

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Jul 12, 2017

genomeweb - After Securing CE-IVD for Debut Hereditary Cancer Dx, Korea’s NGeneBio Readies NGS Tests for Launch

NEW YORK (GenomeWeb) – Fresh from achieving a CE-IVD mark for its flagship next-generation sequencing test for hereditary breast and ovarian cancer, Korean molecular diagnostics startup NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in its home market, while envisioning a 2019 submission to the US Food and Drug Administration.

Moreover, the company is readying a number of new sequencing panels, particularly companion diagnostics for cancer drugs, which NGeneBio considers its primary focus, according to YoungJoon Moon, the firm’s director of business development.

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Jul 12, 2017

PRNewswire - Korean IVD startup NGeneBio receives CE-IVD mark for next generation sequencing-based BRCA 1/2 test panel and clinical analysis software



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.

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Jul 6, 2017

genomeweb - NGeneBio Garners CE-IVD Mark for NGS BRCA Test

NEW YORK (GenomeWeb) – NGeneBio, a Korean molecular diagnostics startup, said today that it has achieved a CE-IVD mark for its BRCAaccuTest and clinical analysis software.

Seoul-based NGeneBio said the amplicon-based, targeted next-generation sequencing panel can be used to detect mutations in the BRCA1 and BRCA2 genes associated with predisposition to breast and ovarian cancers. The test is performed using Illumina instruments and is run in combination with NGeneBio’s NGeneAnalySis software.

CEO Daechul Choi said in a statement that NGeneBio is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries “with competencies in clinical validated quality and reliability.” Choi said that the firm aims to have it cleared as an in vitro diagnostic by the Korean Ministry of Food and Drug Safety later this year. The test became available for research use last year.

NGeneBio was established in 2015 as a joint venture between Gencurix, a Seoul-based molecular diagnostics company that has developed a PCR-based breast cancer test, and Korea Telecom. NGeneBio said it is currently developing other assays for solid and hematological cancers, including a companion diagnostic for patients undergoing treatment with PARP inhibitors. The company hopes to launch these tests by year end.

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About us

Company details

NGeneBio Co., Ltd. was founded in October 2015, develops next generation sequencing (NGS)-based in vitro diagnostics (IVD)/companion diagnostics (CDx) products and clinical bioinformatics software (SW).
The company launched NGS-based hereditary breast/ovarian cancer panel (BRCAaccuTest) with clinical analysis SW (NGeneAnalySys) and received CE-IVD mark in Jun/2017.
NGS panels for solid tumor (SOLIDaccuTest)/hematologic malignancies (HEMEaccuTest) and BRCA PARP inhibitor CDx test will be launched, inclusive of clinical data analysis and report generation SW platform. In support of oncology laboratory medicine community, our mission is to provide clinically validated NGS-IVD/CDx products/services with the convergence of innovative biotechnology and bioinformatics.

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Company data

Sales volume

< 1 Mio US $

Number of employees

20-49

Foundation

2015

Area of business
  • Diagnostics
  • Medical Services and Publications

Company information as a PDF file