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COMPANY:
NGeneBio

i
Other names: NGeneBio | NGeneBio | NGeneBio Co., Ltd. | NGeneBio Co., Ltd | NGeneBio Co. Ltd. | NGeneBio Co. Ltd
Related tests:
Evidence

News

16d
EngenBio acquires CLIA Lab, located in San Diego, USA (NGeneBio Press Release)
"NGeneBio...announced on the 22nd that NGeneBioAI, an American corporation, will acquire the CLIA (laboratory standard certification) lab facility located in San Diego, USA. revealed...The CLIA Lab to be acquired this time is a facility established in 2022 by Vertis...and has acquired CLIA (Laboratory Standard Certification ) and CAP ( College of American Pathologists ) certification. The company explained that it will actively utilize the CLIA lab to discover new biomarkers and provide analysis services in the cancer and dementia fields in the United States in the future." "
M&A
1m
EnGenBio signs strategic partnership MOU with Genolution (NGeneBio Press Release)
"Engenbio...announced on the 13th that it has signed a business agreement with Genolution...Through this business collaboration, NGenBio plans to cooperate with Genolution in launching an expandable system to automate the entire NGS testing workflow, including nucleic acid extraction, library production, and data analysis steps."
Licensing / partnership • Launch
2ms
EnGenBio launches global on-premise cancer genome analysis solution (NGeneBio Press Release)
"NGeneBio...has launched its automated cancer genome analysis software, NGeneAnalySys™ (NGAS), on -premise. On the 1st, they announced the global launch of a type solution and announced that they would expand into an AI- based customized disease solution business."
Launch
3ms
EnGenBio supplies new blood cancer precision diagnosis products to Seoul National University Hospital (NGeneBio Press Release)
"Engenbio...announced on the 24th that it will supply a new blood cancer precision diagnosis product (HEMEaccuTest ™) to Seoul National University Hospital...The Him Accu Test is a product that additionally applies cancer genes to reflect the newly revised WHO (World Health Organization) blood cancer diagnosis guidelines. Unlike existing PCR testing methods, which require testing for each genetic mutation each time, NGS testing based on the Him Accu Test diagnostic kit can diagnose various genetic mutations related to blood cancer with a single test. The Power Accu Test has the advantage of providing customized treatment benefits to patients and providing various information to hospitals through a single test."
Commercial
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HEMEaccuTest™
3ms
EngenBio signs MOU with Vertis to develop multi-omics-based AI early diagnosis technology (NGeneBio Press Release)
"Engenbio...Vertis...are working on AI early diagnosis based on Multi Omics. It was announced on the 10th that a business agreement was signed for technology development and commercialization...Through this business agreement, the two companies plan to establish a strategic partnership and promote commercialization related to the development of precise diagnosis and early diagnosis technology for high-risk diseases such as cancer and dementia . In particular, we plan to focus our capabilities on developing multi-omics-based AI diagnostic technology that combines the strengths of both companies: genomic data analysis and proteome data analysis technology."
Licensing / partnership
4ms
NGeneBio gets approval for cancer diagnostic device in Thailand (The Korea Economic Daily)
"South Korean medical diagnostic company NGeneBio Co. announced on Friday that it has received approval for the sale of its in-vitro diagnostic medical device, 'SOLIDaccuTest DNA,' based on next-generation sequencing (NGS) technology from the Thailand Food and Drug Administration."
Non-US regulatory
5ms
NGeneBio’s blood cancer diagnostic panel gets permit in Thailand (Korea Biomedical Review)
"NgeneBio, a Kosdaq-listed biotech firm, said Tuesday that it has obtained marketing authorization for Hemeaccutest, a blood cancer precision diagnostic panel based on next-generation sequencing (NGS) technology, from the Thai Food and Drug Administration (TFDA). Hemeaccutest, utilizing NGS, can identify mutations in over 100 genes associated with various hematological malignancies, such as myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and lymphomas....NGeneBio is currently in the process of obtaining TFDA marketing authorization for other flagship products: Solidacutest, a precision diagnostic panel for solid tumors, and HlaacutestAll, a precision diagnostic panel for histocompatibility antigens."
Non-US regulatory • Regulatory
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HEMEaccuTest™
5ms
EnGenBio launches NGS-based cancer companion diagnosis analysis software (NGeneBio Press Release)
"NGeneBio...announced the target of targeted therapy and immunotherapy in NGeneAnalySys, its next-generation sequencing technology-based cancer gene analysis software. It was announced on the 6th that it has launched a version with an added function that provides a cancer companion diagnosis report that can check biomarkers."
Launch
7ms
EnGenBio participates in the World Lung Cancer Society… Introducing a product that can predict lung cancer recurrence and prognosis using blood (NGeneBio Press Release)
"NGenBio has developed 'ctDNAaccuPanel™ Lung', a lung cancer precision diagnosis technology that analyzes with high precision information on circulating tumor DNA (ctDNA) present in trace amounts in the blood using 'Liquid Biopsy' technology from the World Lung Cancer Association.' is scheduled to be presented."
Clinical
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ctDNAaccuPanel™ Lung
8ms
Ngenbio, global business reorganization... Targeting the US NGS market (NGeneBio Press Release)
"NGENBio...held an online company briefing session for institutions on the 30th and announced that it would reorganize into a global business system...NGeneBio will reorganize its precision diagnosis business system with NGeneBio headquarters, CLIA Lab, which is scheduled to be acquired, and NGeneBioAI, a US corporation. It is a strategy to strengthen global competitiveness by specializing each company's business field."
Regulatory
8ms
NgenBio, strategic alliance with MGI, a global NGS equipment company (NGeneBio Press Release)
"NGENBIO...announced on the 18th that it had signed a business agreement with MGI...Through this business agreement, the two sides will apply NgenBio's NGS cancer precision diagnosis product to MGI's NGS platform, DNBSEQ-G99 sequencer, Asian region...They plan to strengthen their competitiveness in the precision medicine field by promoting joint business development, such as promotion of local joint commercialization, joint marketing and global distribution cooperation, and production of equipment and NGS diagnostic product packages."
Licensing / partnership
9ms
NGeneBio establishes 'NGeneBioAI', a US corporation... Full-fledged entry into the US_Final (NGeneBio Press Release)
"NGeneBio...announced on the 24th that it had established 'NGeneBioAI', an AI precision diagnosis software company in the US. NGeneBioAI is a corporation in which NGeneBio has invested 100% of its capital, and will play a role as a bridgehead for NGeneBio's 'NGene Precision Diagnosis Platform 'to advance into the US in the US cancer diagnosis market worth about $ 4.1 billion."
Commercial
9ms
NGENBio exports blood cancer precision diagnosis products to Germany... Full-fledged entry into Europe (NGeneBio Press Release)
"NGENBio...will start supplying blood cancer test products to Labor Volkmann of Limbach Group in Germany announced on the 26th...Volkman Lab is providing NGS cancer screening services to the Limbach Group . In order to promote the convenience of patients, clinicians, and clinical laboratories, NGeneBio's NGS technology-based blood cancer precision diagnosis product, HEMEaccuTest, and analysis software, NGeneAnalySys, were introduced in earnest."
Commercial
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HEMEaccuTest™
12ms
NgenBio participated in the Spring Symposium of the Korean Society of Laboratory Medicine (NGeneBio Press Release)
"NGENBio...held the Korean Society of Laboratory Medicine held at the BEXCO Convention Hall in Busan from April 27 to 28. It was announced on the 27th that it would participate in the 2023 Spring Symposium...NgenBio plans to set up an exhibition booth at the event and promote its NGS precision diagnosis technology and new products to hospital officials, universities, corporate research institutes, and public institution officials who visited the site. In particular, HEMEaccuTest™, a precision diagnosis product for blood cancer, which is closely related to the topic of overseas speakers, will be introduced as the main focus...In addition, the FLT3-ITD test product (MRDaccuPanel™ AML FLT3-ITD) for acute myeloid leukemia (AML) micro-residual disease, which is scheduled to be released, will be introduced at this conference."
Clinical
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HEMEaccuTest™ • MRDaccuPanel™ AML FLT3-ITD
12ms
NGeneBio, Agilent Technologies Korea to expand NGS business (Korea Biomedical Review)
"NGeneBio said it agreed with Agilent Technologies Korea...to cooperate in the Korean and international next-generation sequencing (NGS) precision diagnostics market...Under the latest agreement, NGeneBio's solid cancer precision diagnostic product, ONCOaccuPanel will be applied to Agilent's Magnis NGS Prep System. Then, Agilent can sell it as a package."
Licensing / partnership
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OncoaccuPanel™
1year
NGeneBio expands NGS-breast cancer diagnostic to Thailand (Korea Biomedical Review)
"NGeneBio said on Thursday that it launched its next-generation sequence (NGS)-based breast cancer diagnostic service in a newly installed inspection laboratory of a Thai consignment inspection agency, MP Group....NGeneBio plans to provide its NGS-based precision diagnosis services to medium and large hospitals, government-affiliated medical institutions, health centers, and the general public through MP Group's newly opened laboratory. The service launched by the MP Group laboratory uses NGeneBio’s BRCAaccuTest PLUS test to identify the BRCA gene which is related to breast cancer and ovarian cancer."
Launch non-US • Clinical
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BRCAaccuTest PLUS
1year
NGeneBio to commercialize liquid biopsy MRD test for AML by 2024 (Korea Biomedical Review)
"NGeneBio said...that it signed a technology transfer contract with The Catholic University of Korea Industry-Academic Cooperation Foundation and Dow Biomedica to commercialize a product that can check the variation of minimal residual disease (MRD)."
Commercial
almost2years
NGeneBio receives CE-IVD mark for NGS-based cancer panel (Genomeweb)
"South Korean diagnostics company NGeneBio said...that it has received CE-IVD marking for its next-generation sequencing-based comprehensive genomic profiling panel for cancer, OncoaccuPanel."
European regulatory
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OncoaccuPanel™