The World's First Gene Mutation Detection Kit for Brain Glioma Approved for Marketing

Release time:2018-07-30

The Human IDH1 Gene Mutation Detection Kit' and the 'Human TERT Gene Promoter Mutation Detection Kit' (hereinafter referred to as the IDH1/TERT Genetic Testing Kit) independently developed by Genetron Health have been reviewed by the China Food and Drug Administration (CFDA) and become the world's first testing kit applicable to brain glioma IDH1/TERT genes approved for marketing!

The hotspot mutations of the IDH1/2 were firstly found in 2009 by the Professor at Duke University and his partners in patients of adult glioblastoma (a malignant brain tumor), and the results were published in Science and New England Journal of Medicine. In 2013, the Professor at Duke University discovered that TERT promoter mutation is a key driver of many common tumors and can serve as another important basis for molecular classification of brain glioma. The results were published in PNAS. Subsequent studies have shown that IDH gene mutations and TERT promoter mutations can be used for molecularly classification for about 80% of brain glioma patients.

Based on this, at the invitation of WHO in 2016, the Professor at Duke University participated in compiling guidance on new WHO Classification of Tumors of the Central Nervous System, introducing molecular classification standards for brain tumors, such as IDH1/2, which set a record in human history to use molecular classification as a gold standard for brain tumor diagnosis. Following the discovery of IDH mutations and TERT promoter mutations, the Professors at Duke University discovered the molecular classification of two new glioblastomas in 2018, thus basically completing the genetic mapping of glioblastoma. The results were published in Nature Communications; the “encyclopedic” research review on IDH led by the Professor at Duke University was also published in Cancer Cell in 2018, describing the preclinical and clinical studies on IDH inhibitors in brain glioma and acute myeloid leukemia (AML) as well as potential alternative therapies and immunotherapies for people carrying IDH1/2 mutant tumors.Positioned to serve the full cycle of precision medicine of cancer, Genetron Health, since its establishment, has been focusing on creating a business model of “IDT Services + IVD Products” and has deployed molecular testing services and products for multiple cancers:

Inspection Service

The company has been leading in the field of neurological tumors and is accelerating the product and services  development for specific cancers that are common in Chinese people such as cancers of the respiratory system, the digestive system and the urinary system cancer; meanwhile, through consistent efforts in liquid biopsy and early cancer screening, it has taken the lead to promote two liquid biopsy products based on cerebrospinal fluid and China’s first genetic testing product for urothelial tumors based on liquid biopsy, which can achieve early detection and dynamic monitoring.

IVD Products

In addition to the two kits launched to the market this time, the biochip reader GENETRON 3D (Registration No.: 20172400136) was also approved for marketing at the end of 2017. In the future, Genetron Health will keep launching IVD products applicable to more cancers and more technical platforms and will be dedicated to constructing a perfect closed loop from basic research in cancer genomics to clinical applications.

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