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TEST:
HEMEaccuTest™

Company:
NGeneBio
Type:
CE Marked
Related tests:
Evidence

News

6ms
NGenBio successfully supplies its first paid NGS analysis software to Romania (NGeneBio Press Release)
"NGenBio...announced on the 26th that it has successfully launched its automated genome analysis software, NGeneAnalySys™ (NGAS), for the first time in Romania."
Launch
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BRCAaccuTest PLUS • HEMEaccuTest™ • SOLIDaccuTest DNA
9ms
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™
11ms
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™
1year
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™
over1year
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