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COMPANY:
Genetron Health

i
Other names: Genetron Health | Genetron Holdings Limited | Genetron Holdings Ltd | Genetron Holdings Ltd. | Genetron Health Technologies | Genetron Health Technologies, Inc. | Genetron Health Technologies, Inc | Genetron Health Technologies Inc | Genetron Health Technologies Inc.
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News

14d
Genetron Health announces completion of going private transaction (Genetron Health Press Release)
"Genetron Holdings Limited...announced today the completion of its merger (the 'Merger') with Genetron New Co Limited ('Merger Sub'), pursuant to the previously announced agreement and plan of merger, dated as of October 11, 2023 (the 'Merger Agreement'), among the Company, New Genetron Holding Limited ('Parent') and Merger Sub. As a result of the Merger, the Company has become a wholly owned subsidiary of Parent and will cease to be a publicly traded company."
M&A
6ms
Genetron Health enters into definitive merger agreement for going private transaction (Genetron Health Press Release)
"Genetron Holdings Limited...announced today that it has entered into a definitive Agreement and Plan of Merger (the 'Merger Agreement') with New Genetron Holding Limited ('Parent') and Genetron New Co Limited ('Merger Sub'), a wholly-owned subsidiary of Parent."
M&A
7ms
CStone Announces NMPA Approval of the AYVAKIT (avapritinib) Companion Diagnostic (CDx) Kit Developed in Partnership with Genetron (CStone Pharma Press Release)
"CStone Pharmaceuticals...announced that the AYVAKIT® (avapritinib) companion diagnostic (CDx) kit, known as 'Human platelet-derived growth factor receptor alpha (PDGFRA) Gene D842V Mutation Detection Kit', developed in partnership with Genetron Holdings Limited (Genetron Health) has been approved by the China National Medical Products Administration (NMPA). This CDx kit is the first companion diagnostic product co-developed through the bridging pathway in China to gain regulatory approval following the release of the companion diagnostic guidelines by NMPA. It is used to detect PDGFRA gene mutations in gastrointestinal stromal tumor (GIST) for patients receiving treatment with AYVAKIT."
Non-US regulatory
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AYVAKIT® CDx test
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Ayvakit (avapritinib)
almost2years
Genetron Health receives CAP Accreditation for its Maryland laboratory (Genetron Health Press Release)
"Genetron Holdings Limited...announced College of American Pathologists (CAP) Accreditation for its laboratory in Maryland, U.S...CAP Accreditation is designed to help laboratories maintain the accuracy of test results and ensure accurate patient diagnosis, meet required regulatory standards and maintain industry-leading best practices. The Maryland laboratory joins the Company’s main lab in Beijing as its second lab that is both CAP and CLIA accredited. With the accreditation the company strengthens its US arm of drug development services conducting discovery and translational research, clinical trial execution and corresponding companion diagnostics development."
Regulatory
almost2years
Genetron Health releases 10 new research results at 2022 American Society of Clinical Oncology (ASCO) annual meeting (Genetron Health Press Release)
"Genetron Holdings Limited...announced the release of 10 research results at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting...Based on Genetron Health’s patented One-Step™ Seq Method and core products such as Onco PanScan™, the results aimed to contribute to the scientific research and clinical practice of full-cycle cancer management."
Clinical data
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Onco PanScan™
almost2years
Genetron Health receives CE Mark for FusionScan Plus Kit for human multi-genes (Genetron Health Press Release)
"Genetron Holdings Limited...announced it has obtained a CE Mark for its FusionScan Plus Kit, an integrated DNA and RNA NGS-based assay for simultaneously detecting multiple gene mutations and fusions with lower thresholds, (Registration number: DE/CA20/01-IVD-Luxuslebenswelt-886/22)."
European regulatory
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FusionScan Plus
almost2years
Genetron Health receives CE Mark for Human B Lymphocyte Minimal Residual Disease Detection Kit Seq-MRD® (Genetron Health Press Release)
"Genetron Holdings Limited...today announced it has received a CE Mark for its proprietary Human B Lymphocyte Minimal Residual Disease Detection Kit (Reversible Termination Sequencing Method), which is also known as Seq-MRD® (Registration Number: DE/CA20/01-IVD-Luxuslebenswelt-190/22)...Based on high-throughput next generation sequencing (NGS) technology, Seq-MRD® assay is intended to test the CDR3 regional sequence of the IgH/K/L gene of the B cell receptor (BCR) in bone marrow samples collected from patients with B lymphpocytic leukemia (B-ALL/CLL) and multiple myeloma (MM) before and after the treatment. By screening out significant and specific clonal rearrangement form in a patient's tumor cells, this approach can detect minimal residual disease and provide a reference for the follow-up treatment of cancer survivors."
European regulatory
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Seq-MRD® assay
2years
Genetron Health presents 17 new research results at American Association for Cancer Research Annual Meeting (AACR) 2022 (Genetron Health Press Release)
"Genetron Holdings Limited...announced the release of 17 research results at the American Association for Cancer Research Annual Meeting 2022 (AACR 2022)...The results emerged from joint studies that Genetron Health conducted with more than 20 leading hospitals in China, which leveraged the Company's 'One-step Seq' patented technology, core products such as the multi-gene NGS panel testing - Onco PanScan™ and the comprehensive sarcoma gene testing - Onco PanScan plus™."
Clinical data
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Onco PanScan™
2years
Publication in clinical and translational medicine demonstrates Mutation Capsule™’s potential in MRD assay developments (Genetron Health Press Release)
"Genetron Holdings Limited...announced that a research piece titled 'Integrated analysis of circulating tumor cells and circulating tumor DNA to detect minimal residual disease in hepatocellular carcinoma' has been published in a highly impactful journal, Clinical and Translational Medicine (Impact Factor: 11.5)...The data showed that the performance of cfDNA based tumor-naïve assays could be further improved by combining with CTCs. These findings underscore the importance of CTC and ctDNA integration in recurrence prediction and could also provide a reference for selecting strategies for HCC MRD surveillance."
Clinical data
2years
Launch
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Seq-MRD® assay
2years
New trial
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HCCscreen™
2years
New trial
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Onco PanScan™
2years
New trial
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HCCscreen™
2years
Genetron Health Announces Companion Diagnostic Collaboration Agreement with HUTCHMED’s ORPATHYS for NSCLC (GlobeNewswire)
"Genetron Holdings Limited...announced that it has signed a collaboration agreement with HUTCHMED (China) Limited...for the joint development of a companion diagnostic (CDx) test for ORPATHYS® (savolitinib) in China. Under the agreement, the partners plan to jointly validate and register Genetron Health’s approved NGS-based 8-gene Lung Cancer Assay (Tissue) as CDx for ORPATHYS®."
Licensing / partnership
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Lung Cancer 8-Gene Kit
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Orpathys (savolitinib)
2years
Genetron Health announces companion diagnostic collaboration agreement with HUTCHMED’s ORPATHYS® for NSCLC (Genetron Health Press Release)
"Genetron Holdings Limited...announced that it has signed a collaboration agreement with HUTCHMED (China) Limited...for the joint development of a companion diagnostic (CDx) test for ORPATHYS® (savolitinib) in China...Under the agreement, the partners plan to jointly validate and register Genetron Health’s approved NGS-based 8-gene Lung Cancer Assay (Tissue) as CDx for ORPATHYS®."
Licensing / partnership
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Lung Cancer 8-Gene Kit
over2years
Genetron Health’s social contribution campaign to make precision medicine more accessible (Genetron Health Press Release)
"Genetron Health...announced the launch of the 'Lung Loves New Life' genetic testing campaign, in collaboration with the China Primary Health Care Foundation. As the sole corporate donor, Genetron Health will provide free genetic testing services (using its 8-gene lung cancer assay) for 10,000 Chinese lung cancer patients. These tests will become an important reference for patients to customize their follow-up treatment regimens."
Clinical
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Lung Cancer 8-Gene Kit
over2years
New trial
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Onco PanScan™
over2years
New trial
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HCCscreen™
over2years
Genetron Health announces co-development agreement with AstraZeneca R&D China for personalized MRD tests for solid tumors in China (Genetron Health Press Release)
"Genetron Holdings Limited...announced that it has signed a collaboration agreement with AstraZeneca R&D China...for the joint development in China of next-generation sequencing (NGS)-based tumor-informed (personalized) minimal residual disease (MRD) tests for various solid tumor types. AstraZeneca plans to incorporate the co-developed tests for China-specific studies...Under the agreement, the companies will jointly invest capital for this collaboration, and will work together to develop and validate the personalized, solid tumor MRD assays for cancer monitoring and recurrence in China."
Licensing / partnership
over2years
Genetron Health reveals two cancer research study results at the Association for Molecular Pathology 2021 Annual Meeting (Genetron Health Press Release)
"Genetron Holdings Limited...announced the release of two research results from its Seq-MRD® and FusionScan Plus product studies at the Association for Molecular Pathology 2021 annual meeting...Seq-MRD® detects minimal residual disease (MRD) in B-lymphoid malignancies, while FusionScan Plus can simultaneously detect a wide range of gene mutations and fusions. The two studies (#1064612, #1062999) verified the high sensitivity and high specificity of the two products, providing important insights for clinical diagnosis, medication guidance and monitoring of cancer relapses."
Clinical data
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FusionScan Plus
over2years
Genetron Health establishes strategic partnership with NeoGenomics to drive global oncology drug research and development (Genetron Health Press Release)
"Genetron Holdings Limited...announced that it has entered into a strategic partnership with NeoGenomics, Inc...Genetron Health and NeoGenomics, Inc. will partner globally to provide select harmonized clinical trials, global translational research for pharmaceutical groups and technology platform providers that need a China arm for global or China focused trials. Additionally, NeoGenomics will support Genetron Health on ex-China trials requiring US, APJ and/or EMEA based trials. This will include developing and operating clinical trials for both oncology drugs and their corresponding companion diagnostics (CDx) products."
Licensing / partnership
over2years
Genetron Health’s multi-gene mutation detection kit Onco PanScan™ obtains CE Mark (Genetron Health Press Release)
"Genetron Holdings Limited...announced that its proprietary large-panel product, Onco PanScan™ (Mutation Detection Kit for Human Multi-Genes), has obtained the CE mark, a compulsory certification mark required for marketing and distribution in the European Union...Onco PanScan™ provides comprehensive and accurate genomic profiling to guide personalized medicine for cancer patients with a single test, making it suitable for targeted therapy, immunotherapy (TMB assessments, MSI, immune efficacy-related genes) treatment guidance, and screening for susceptibility to genetic risks."
European regulatory
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Onco PanScan™
over2years
Genetron Health’s liver cancer screening results and technology findings included in the Chinese Journal of Hepatology (Genetron Health Press Release)
"Genetron Holdings Limited...today announced that the clinical results and technology findings of its early liver cancer screening product for hepatocellular carcinoma (HCC), HCCscreen™, were included in the October 2021 publication of Chinese Journal of Hepatology."
Clinical
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HCCscreen™
over2years
Genetron Health and Fosun Pharma Announce Exclusive Partnership to Commercialize Seq-MRD in China (GlobeNewswire)
"Under the agreement, Genetron Health and Jiangsu Fosun Pharma will work exclusively together to co-market and co-promote Seq-MRD® in hematologic-focused hospitals and clinics across designated territories in China. Both parties intend to serve patients afflicted by lymphoid malignancies, including acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and chronic lymphoid leukemia (CLL)."
Licensing / partnership