Genetron Health Receives EU CE Qualification for Seq-MRD, a Human Lymphocyte Minimal Residual Disease Detection Product

On April 19, Genetron Health (Nasdaq: GTH) announced that its self-developed human lymphoid B cell minimal residual disease gene detection kit (reversible end termination sequencing method) (ie Seq-MRD®) has obtained EU CE qualification (Registration number: DE/CA20/01-IVD-Luxuslebenswelt-190/22)
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Seq-MRD® is based on a next-generation high-throughput sequencing (NGS) platform to specifically detect B in B-lymphocytic leukemia (B-ALL/CLL) and multiple myeloma (MM) patients in pre/post-treatment bone marrow samples The sequence of the CDR3 region of the cell receptor (BCR) IgH/K/L gene can screen out the significant and specific clonal rearrangement of tumor cells in patients.
These tumor cells can be tracked after treatment, that is, minimal residual disease.
Detection, so as to provide a reference for the follow-up treatment plan for cancer survivors
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Through the optimization of Genetron's "one-step" patented technology (Chinese invention patent ZL 201710218529.
4), the Seq-MRD® library construction process can be completed in one PCR (polymerase chain reaction), and the risk of sample contamination and false positive results is extremely high greatly reduced
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The simple operation process combined with Genetron's automated bioinformatics analysis solution enables Seq-MRD® to have the core advantages of high-throughput, fast and convenient, stable and accurate, efficient and economical, and has broad application prospects
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The recently completed performance experiments have comprehensively confirmed the product performance in terms of sensitivity, accuracy, specificity, and precision.
Among them, a comparative study of 128 clinically confirmed samples showed that Seq-MRD® and traditional flow cytometry ( FCM) positive detection was highly consistent
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More importantly, 10 samples were negative for FCM, but positive for Seq-MRD®, demonstrating the higher sensitivity of Seq-MRD®
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In October 2021, Genetron Health and Jiangsu Fosun Pharma signed an exclusive commercialization cooperation agreement for Seq-MRD®.
In key hospitals of hematology in designated areas in China, through Fosun Pharma's large-scale and experienced professional hematology and tumor marketing team, they will jointly Sales and co-promotion of Seq-MRD® to meet the clinical testing needs of patients with lymphatic hematological tumors
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In addition to Seq-MRD®, Genetron Health is also actively promoting the clinical certification and business layout of multiple IVD products in the domestic and international markets.
Currently, there are human IDH1 gene mutation detection kits (PCR-fluorescent probe method) (National Instruments Note Standard 20173401602), Human TERT Gene Promoter Mutation Detection Kit (PCR-Fluorescent Probe Method) (Guoji Zhuzhun 20173401600), Human 8 Gene Mutation Joint Detection Kit (Semiconductor Sequencing Method) (Guoji Zhuquan 20203400072), Products such as the Human 825 Gene Mutation Detection Kit (Combined Probe-Anchored Polymerization Sequencing Method) and other products have successively obtained the EU CE qualification.
In the future, Genetron Health will closely follow the clinical needs of molecular detection, accelerate the market transformation of products, and provide patients with more accurate, more accessible medical services
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About CE CE Marking (CE Marking) is a product safety mark that must be carried when some products are listed in some European countries in accordance with regulatory requirements
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A product bearing the CE mark means that the product complies with the basic/general requirements of the relevant EU product regulations, is suitable for the intended use, and can be freely circulated in countries that require the CE mark
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