COMPANY:

Genetron Health

"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."

"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."

"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)."

"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."

"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™."

"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."

Investor Presentation

Investor Presentation

Investor Presentation

Investor Presentation

"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®."

"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®."

"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."

Investor Presentation

Investor Presentation

"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."

"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."

"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."

"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."

"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."

"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)."

"Genetron Holdings Limited...announced a partnership with IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics....The two parties will cooperate together on research and development for synthetic lethal inhibitors that are based on new targets, and the development of companion diagnostic products."

"Genetron Holdings Limited...announced that it has partnered with a consortium of 14 top Chinese hospitals to release 13 key research findings at the ESMO 2021 Congress, hosted by the European Society for Medical Oncology...The research adopted Genetron’s proprietary technology such as the One-Step Seq Method, and core products such as Onco PanScan™ and its thyroid cancer full-cycle gene test. These findings were from both multi-cancer studies and high-risk single cancer studies, which covered lung cancer, thyroid cancer, cholangiocarcinoma, and central nervous system cancers."

"Genetron Holdings Limited...announced that its Beijing clinical laboratory has received full marks under the National Center for Clinical Laboratories’ ('NCCL') first nationwide, external quality assessment ('EQA') of NGS-based comprehensive genomic profiling for solid tumors...Genetron Health participated in the assessment using its proprietary NGS-based comprehensive genomic profiling product, Onco PanScan™ and achieved full marks without any errors."

"Genetron Holdings Limited...announced that its AYVAKIT® (avapritinib) companion diagnostic (CDx) kit, developed in partnership with CStone Pharmaceuticals...has entered the priority review and approval process under the National Medical Products Administration (NMPA) in China...As a proprietary companion diagnostic for AYVAKIT®, the CDx kit can be used to effectively detect PDGFRA D842V gene mutation in GIST patients, providing accurate molecular diagnosis for targeted drug application which may translate into durable clinical benefits for these patients."

"Genetron Holdings Limited...today announced that it will work with Guizhou Province’s Dafang County authorities to lead the 'Early Screening for Regional Liver Cancer Prevention and Containment Demonstration Project'...HCCscreen™, Genetron Health's blood-based early screening test for hepatocellular carcinoma, will play a key role in this project."

"Genetron Health said Tuesday that it has received the CE mark for its eight-gene lung cancer sequencing assay. The test kit, which has also been approved by China’s National Medical Products Administration, uses a technology called One-Step Seq, which allows for a single-reaction library construction process, minimizing manual operation and reducing the chance of contamination."

"Genetron Holdings Limited (“Genetron Health” or the “Company”, NASDAQ: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today announced the release of 16 research results at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The results were from studies that Genetron Health conducted in partnership with 16 leading hospitals in China...These studies analyzed nearly 10 different types of high-incidence cancers, covering lung cancer, bladder cancer, and thyroid cancer. They also provided important insights that can enable the accurate diagnosis and treatment of cancer."

"Genetron Holdings Limited...today announced a strategic partnership with JD Health, a subsidiary of JD.com, Inc., and the largest online healthcare platform in China. The two companies aim to create innovative solutions for full-cycle cancer management...The Company will cooperate with JD Health to cover early cancer screening, molecular profiling, therapy selection, and drug resistance monitoring, leveraging the Company’s HCCscreen™ liquid biopsy product for hepatocellular carcinoma and its NMPA-approved 8-gene lung cancer detection kit...This agreement marks Genetron Health’s implementation of an online healthcare platform as the fourth commercialization channel for HCCscreen™, in addition to its three existing channels: medical examination centers, public health projects, and hospitals. The partnership also reflects JD Health’s goal to help manage cancer across all stages for its customers."

"Genetron Holdings Limited (“Genetron Health”...announced that the National Medical Products Administration (NMPA) has approved its 8-gene Lung Cancer Assay and high-throughput NGS platform GENETRON S2000 to empower comprehensive panel genomic testing for more patients."

"Genetron Health...announced a strategic cooperation with Siemens Medical-the two parties will work together to promote Genetron Health Gene sequencer GENETRON S5...and Genetron Health Human 8 Gene Mutation Test Kit...hereinafter referred to as 'Lung Cancer 8-Gene Kit') Large-scale application in the Chinese hospital market will bring efficient and accurate individualized diagnosis and treatment services to more non-small cell lung cancer (NSCLC) patients, and promote the standardization of molecular testing in hospitals."

"Genetron Health…today released the latest data of its blood-based liver cancer early screening test HCCscreen™️…’HCCscreen™️ Investigational Study’ (HIT) is a multi-center prospective study initiated by Genetron Health and the National Cancer Center of China in 2019. As of February 2021, the company has completed the follow-up of 1,615 hepatitis B surface antigen-positive patients. The data shows that HCCscreen™️ achieved 88% sensitivity and 93% specificity, while ultrasound combined with alpha-fetoprotein (AFP) detection achieved 71% sensitivity and 95% specificity. HCCscreen™️ also achieved a positive predictive value (PPV) of 40.9% and a negative predictive value (NPV) of 99.3%."

"Genetron Health…announced today that it has entered into a partnership with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (hereinafter referred to as ‘CP’), signed an exclusive strategic cooperation agreement in China for HCCscreen™️…This time, Genetron Health has joined hands with top domestic pharmaceutical companies to open up the hospital market. Based on the existing medical examination institutions and government livelihood projects, it has realized the three major business path layouts of HCCscreen™️, which will further increase the penetration rate of HCCscreen™️ in the early cancer screening market in China And penetration rate."

"Genetron Holdings Limited (‘Genetron Health’ or the ‘Company’, Nasdaq: GTH)…today announced that its blood-based next-generation sequencing (NGS) test, HCCscreen™, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). Based on the correspondence with Center for Devices and Radiological Health (CDRH) of the FDA, HCCscreen™ is intended for early detection of hepatocellular carcinoma…"