A Multicenter Clinical Trial to Evaluate the Clinical Performance and Accuracy of the Human DAB2IP, CHFR, and GRASP Gene Methylation Kit (PCR-fluorescence Probe) in Patients With Suspected Hepatocellular Carcinoma

This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection. The test results are compared against clinical reference standards, including pathological and/or imaging diagnoses, to assess the product's diagnostic performance. Additionally, for each gene detectable by the HepaAiQ assay, digital PCR is used as a comparator to validate analytical accuracy. The dual approach-clinical and analytical validation-supports the intended use of the test and provides sufficient clinical evidence for its registration and regulatory submission in China.

开始日期2025-02-25

申办/合作机构

江苏鹍远生物科技股份有限公司

[+1]

NCT06440018

/ RecruitingN/A

INSPIRE: Integrating Circulating DNA Methylation and Fragmentomics to Scan and Pinpoint Cancer Signals Effectively

This research constitutes a multi-centric, case-control designed investigation aimed at developing and implementing a blinded validation of a machine learning-powered, multi-cancer early detection model. This is to be achieved through the prospective collection of blood specimens from newly diagnosed cancer patients and individuals devoid of a confirmed cancer diagnosis

开始日期2024-07-20

申办/合作机构

江苏鹍远生物科技股份有限公司

[+6]

NCT06178809

/ RecruitingN/A

Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA Predicting Postoperative Recurrence and Progression After Systemic Therapy of Hepatocellular Carcinoma

This study aims to combine biomarker characteristic atlas and ctDNA detection technology to establish a precise standard scheme for minimal residual diagnosis of liver cancer after surgery and systemic treatment.

开始日期2023-12-25

申办/合作机构

江苏鹍远生物科技股份有限公司

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项与江苏鹍远生物科技股份有限公司相关的文献（医药）

2025-01-01·International Journal of Endocrinology

Molecular Diagnosis of Thyroid Nodules Using Next‐Generation Sequencing in the Chinese Population

Article

作者: Wu, Jiajia ; Chen, Hui ; Chen, Yan ; Liu, Wei ; Ren, Yuanyuan ; Zhang, Hongfeng ; Liu, Rui ; Ji, Yuan ; Zhu, Min ; Jiang, Zhengzeng

Background: Fine‐needle aspiration (FNA) cytology remains a challenge in the diagnosis of indeterminate thyroid nodules. Molecular testing can bridge the gap left by FNA cytology and improve the diagnostic accuracy of FNA.Methods: 786 FNA samples and 40 formalin‐fixed paraffin‐embedded (FFPE) specimens from thyroid nodules were enrolled in next‐generation sequencing (NGS) molecular testing, which included gene mutation and gene fusion analysis. The molecular diagnostic performance was assessed by analyzing sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predictive value (PPV).Results: Among 826 thyroid nodules, 409 were NGS‐positive (49.52%), with a high prevalence of BRAF V600E (36.32%, 300/826) and RAS (9.32%, 77/826) mutations, a low prevalence of TERT promoter mutations (1.69%, 14/826), and gene fusions involving RET (1.82%, 15/826), NTRK3 (0.73%, 6/826), ALK (0.24%, 2/826), and PAX8-PPARG (0.12%, 1/826). With the analysis of genetic profiles in thyroid nodules, BRAF V600E, TERT mutations, and gene fusions were included in the 6‐gene test panel. The overall diagnostic performance of the 6‐gene test panel, including sensitivity, specificity, accuracy, NPV, and PPV, was 84.87%, 89.61%, 86.26%, 71.13%, and 95.15%, respectively. For thyroid nodules in Bethesda III, IV, and V, the diagnostic sensitivity, specificity, accuracy, NPV, and PPV of the panel were 85.71%, 88.89%, 86.36%, 61.54%, and 96.77%, respectively.Conclusion: The results reveal that the 6‐gene test panel as a “rule in” test in a clinical setting improves the accuracy of FNA cytology, potentially assisting in the diagnosis of the thyroid nodules with indeterminate FNA cytology.

2024-04-01·Heliyon

Correlation between NGS panel-based mutation results and clinical information in colorectal cancer patients

Article

作者: Ding, Shanshan ; Wang, Hongming ; Liu, Hongmei ; Zhao, Huan ; Wang, Chan ; Sui, Yi ; Xu, Lin ; Yang, Huimin ; Sun, Suozhu ; Guo, Jing ; Zheng, Zhaoqing ; Liu, Jinhong ; Quan, Lanju ; Wu, Xizhao ; Liu, Ye ; Zhang, Ruya ; Wang, Fei ; Zhang, Yunzhi ; Wen, Zhaohong ; Cheng, Bo ; Liu, Shan

Early mutation identification guides patients with colorectal cancer (CRC) toward targeted therapies. In the present study, 414 patients with CRC were enrolled, and amplicon-based targeted next-generation sequencing (NGS) was then performed to detect genomic alterations within the 73 cancer-related genes in the OncoAim panel. The overall mutation rate was 91.5 % (379/414). Gene mutations were detected in 38/73 genes tested. The most frequently mutated genes were TP53 (60.9 %), KRAS (46.6 %), APC (30.4 %), PIK3CA (15.9 %), FBXW7 (8.2 %), SMAD4 (6.8 %), BRAF (6.5 %), and NRAS (3.9 %). Compared with the wild type, TP53 mutations were associated with low microsatellite instability/microsatellite stability (MSI-L/MSS) (P = 0.007), tumor location (P = 0.043), and histological grade (P = 0.0009); KRAS mutations were associated with female gender (P = 0.026), distant metastasis (P = 0.023), TNM stage (P = 0.013), and histological grade (P = 0.004); APC mutations were associated with patients <64 years of age at diagnosis (P = 0.04); PIK3CA mutations were associated with tumor location (P = 4.97e-06) and female gender (P = 0.018); SMAD4 mutations were associated with tumor location (P = 0.033); BRAF mutations were associated with high MSI (MSI-H; P = 6.968e-07), tumor location (P = 1.58e-06), and histological grade (P = 0.04). Mutations in 164 individuals were found to be pathogenic or likely pathogenic. A total of 26 patients harbored MSI-H tumors and they all had at least one detected gene mutation. Mutated genes were enriched in signaling pathways associated with CRC. The present findings have important implications for improving the personalized treatment of patients with CRC in China.

2024-02-01·Translational research : the journal of laboratory and clinical medicine

A diagnostic model based on DNA methylation haplotype block characteristics for identifying papillary thyroid carcinoma from thyroid adenoma

Article

作者: Shen, Yuling ; Xu, Dong ; Lai, Yi ; Li, He ; Liu, Yiying ; Gong, Chengxiang ; Feng, Ningning ; Zhang, Yunzhi ; Zhou, Jiaqing ; Liu, Hongmei

Papillary thyroid carcinoma (PTC) is the most prevalent form of thyroid cancer. Methylation of some genes plays a crucial role in the tendency to malignancy as well as poor prognosis of thyroid cancer, suggesting that methylation features can serve as complementary markers for molecular diagnosis. In this study, we aimed to develop and validate a diagnostic model for PTC based on DNA methylation markers. A total of 142 thyroid nodule tissue samples containing 84 cases of PTC and 58 cases of thyroid adenoma (TA) were collected for reduced representation bisulfite sequencing (RRBS) and subsequent analysis. The diagnostic model was constructed by the logistic regression (LR) method followed by 5-cross validation and based on 94 tissue methylation haplotype block (MHB) markers. The model achieved an area under the receiver operating characteristic curve (AUROC) of 0.974 (95% CI, 0.964-0.981) on 108 training samples and 0.917 (95% CI, 0.864-0.973) on 27 independent testing samples. The diagnostic model scores showed significantly high in males (P = 0.0016), age ≤ 45 years (P = 0.026), high body mass index (BMI) (P = 0.040), lymph node metastasis (P = 0.00052) and larger nodules (P = 0.0017) in the PTC group, and the risk score of this diagnostic model showed significantly high in recurrent PTC group (P = 0.0005). These results suggest that the diagnostic model can be expected to be a powerful tool for PTC diagnosis and there are more potential clinical applications of methylation markers to be excavated.

项与江苏鹍远生物科技股份有限公司相关的新闻（医药）

2025-06-16

·Business Wire

Liquid Biopsy Markets by Cancer, Usage, Biomarker, Place, & Product with Price and Volume Outlook, Including Executive and Consultant Guides 2025-2029 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Liquid Biopsy Markets by Cancer, Usage, Biomarker, Place, & Product with Price and Volume Outlook, Including Executive and Consultant Guides 2025-2029" has been added to ResearchAndMarkets.com's offering. Explore the dynamic landscape of the Screening, Diagnostic, Therapy Selection, Minimal Residual Disease, and Screening Market through our comprehensive report, which provides a detailed analysis of price and volume outlooks across different types of cancer. Discover the transformative advancements in cancer diagnostics, particularly the innovative use of in vitro blood testing to detect cancer DNA, paving the way for widespread cancer screening tests. This cutting-edge technology is advancing rapidly, outpacing market growth, and offers a less invasive alternative to traditional surgical biopsies, poised to revolutionize disease diagnosis and monitoring. The report delves into the growth phase of the market, offering insights into its substantial impact on the healthcare industry. It includes a five-year forecast of market size expansion, with detailed projections segmented by country, cancer type, and usage categories-ranging from screening, diagnosis, therapy selection, to recurrence monitoring. Our analysis provides a granular breakdown for 15 countries and 4 regions, alongside specific insights on cancers such as Lung, Breast, Colorectal, Prostate, Cervical, and others. It also explores opportunities and challenges within screening, early detection, diagnostic, therapy monitoring, and recurrence monitoring realms, equipping stakeholders with essential knowledge for making informed investment decisions and accurate market valuations. Capitalizing on the exhaustive market intelligence contained within, this report empowers decision-makers to confidently navigate the evolving cancer diagnostics landscape, leveraging unprecedented technological advancements to enhance patient outcomes and streamline healthcare processes. Key Topics Covered: 1 Market Guides 1.1 Liquid Biopsy Market - Strategic Situation Analysis 1.2 Guide for Executives, Marketing, Sales, and Business Development Staff 1.3 Guide for Management Consultants and Investment Advisors 1.4 Impact of Artificial Intelligence on Liquid Biopsy Market 2 Introduction and Market Definition 2.1 What is Liquid Biopsy? 2.2 The Sequencing Revolution 2.3 Market Definition 2.4 Methodology 2.5 Perspective: Healthcare and the IVD Industry 3 Market Overview 3.1 Players in a Dynamic Market 3.2 Using Biopsies 3.3 Biopsy Sites 3.4 The Situation Today - Biopsy Analysis 3.5 Evidence of Cancer - Liquid Biopsy Technology 3.6 Cancer Treatment Protocol Under Siege 3.7 Structure of Industry Plays a Part 4 Market Trends 4.1 Factors Driving Growth 4.1.1 Non-Invasive Game Changer 4.1.2 Lower Cost 4.1.3 Greater Accuracy 4.1.4 Wide Range of Potential Uses 4.1.5 Aging Population 4.2 Factors Limiting Growth 4.2.1 Lower prices 4.2.2 Lack of Standards 4.2.3 Protocol Resistance 4.2.4 Initial Adoption Cost 4.2.5 Conclusion 4.3 Instrumentation and Automation 4.3.1 Instruments Key to Market Share 4.3.2 Bioinformatics Plays a Role 4.4 Diagnostic Technology Development 4.4.1 Next Generation Sequencing Fuels a Revolution 4.4.2 Impact of NGS on pricing 4.4.3 Pharmacogenomics Blurs Diagnosis and Treatment 4.4.4 CGES Testing, A Brave New World 4.4.5 Biochips/Giant magneto resistance based assay 5 Liquid Biopsy Recent Developments 5.1 Recent Developments - Importance and How to Use This Section 5.1.1 Importance of These Developments 5.1.2 How to Use This Section 5.2 Liquid Biopsy Firm QCDx Closes Financing 5.3 LabCorp Launches Liquid Biopsy 5.4 OncoHelix, AstraZeneca to Provide Prostate Cancer Liquid Biopsy Testing 5.5 Liquid Biopsy Developer Oxford Cancer Analytics Raises $11M 5.6 GeneCentric Therapeutics Launches ExpressCT Liquid Biopsy Platform 5.7 Syantra Closes Financing 5.8 Concerns Over Grail Test Effectiveness 5.9 Guardant Health Sues Tempus for Patent Infringement 5.10 Delfi Dx Liquid Biopsy Technology Shows Promise 5.11 Thermo Fisher Scientific, Bayer to Develop NGS-Based CDx 5.12 Grail Details TBE Method for Cancer Monitoring 5.13 Naveris HPV Liquid Biopsy Test Gets Medicare Coverage 5.14 Personalis NeXT Personal Dx Early-Access Program 5.15 Liquid Biopsy Shortens Time to Treatment 5.16 Guardant Health MRD Test Garners Coverage 5.17 IMBdx, AstraZeneca Expand Prostate Cancer Liquid Biopsy Partnership 5.18 FoundationOne Liquid Biopsy Assay Gets FDA OK as Companion Diagnostic 5.19 Epic Sciences Raises $24M for Breast Cancer Liquid Biopsy Test 5.20 GenoMe Diagnostics Preparing DPCR-Based Ovarian Cancer Test 5.21 Sophia Genetics to Commercialize Liquid Biopsy Test 5.22 Agilent, Qiagen Nab FDA Approvals for Lung Cancer Treatment CDx 5.23 Liquid Biopsy Startup Haystack Oncology Raises $56M 5.24 Hedera Dx to Launch Liquid Biopsy Streamlined Platform 5.25 PamGene Expanding Liquid Biopsy Assays 5.26 Liquid Biopsy Firm Hedera Dx Raises €14M 5.27 MDxHealth Plans One-Stop Shop for Prostate Cancer Dx 5.28 Precision Oncology Dx Access Varies Widely in Europe 5.29 Extracellular Vesicles Show Promise as Early-Stage Cancer Diagnostic 5.30 Predicine Receives CE Mark for Blood and Urine Liquid Biopsy 5.31 BillionToOne Launches First Liquid Biopsy Products 5.32 Dxcover Advances Multicancer Detection Platform 5.33 CorePath Laboratories, Cizzle Biotechnology Partner on Lung Cancer Blood Test 5.34 Illumina Sues Guardant Health Over Patents 5.35 Invitae to Expand Cancer Testing Portfolio 5.36 Cancer Centre, Inivata Partner on Clinical Liquid Biopsy Studies 5.37 IVBH Bio Takes Aim at With Liquid Biopsy Incubator 5.38 Molecular Health, Eone-Diagnomics Ink Liquid Biopsy Partnership 5.39 Delfi Diagnostics Looks To Fragmentation-Based Liquid Biopsy Tech 5.40 BillionToOne Adapting Fetal Dx Tech for Liquid Biopsy 5.41 EDGC to Expand Liquid Biopsy Space With Cell-Free DNA Platform 5.42 Liquid Biopsy Startup BioCaptiva Raises £1M in Seed Funding 5.43 Agilent Enters Liquid Biopsy Market with Resolution Biosciences Acquisition 5.44 Bio-Techne to Acquire Asuragen for up to $320M 5.45 Personalis Broadens Liquid Biopsy Offering 5.46 Exact Sciences to Offer End-to-End Cancer Testing With Ashion Acquisition 5.47 Delfi Diagnostics Plans Multi-Cancer Screening Test 5.48 Menarini's CellSearch Shows Potential to Predict Breast Cancer Prognosis, Treatment Response 5.49 Liquid Biopsy NGS Panels - Diverse Test Claims 5.50 CMS Colon Cancer Screening Memo Bodes Well for Assays 5.51 Natera Liquid Biopsy Test Coverage to Expand 5.52 Freenome Closes Financing to Support Early Cancer Detection Trial 5.53 C$2.6M Liquid Biopsy Initiative 5.54 NeoGenomics, Inivata Partner for Lung Cancer Liquid Biopsy 5.55 Liquid Biopsy Shows Promise as Screen for Cancers 5.56 Inivata launches RaDaRT for the detection of residual disease and recurrence 5.57 Liquid Biopsy Assay Detects 50+ Types of Cancer 5.58 Liquid Biopsy Study Confirms Concordance with Tissue Biopsy 6 Profiles of Key Players 6.1 Admera Health, LLC 6.2 Abbott Laboratories 6.3 AccuraGen Inc. 6.4 Acuamark Diagnostics 6.5 Agilent 6.6 Amoy Diagnostics Co., Ltd. 6.7 Anchor Dx 6.8 ANGLE plc 6.9 Applied DNA Sciences 6.10 ARUP Laboratories 6.11 AVIVA Systems Biology 6.12 Baylor Miraca Genetics Laboratories 6.13 Beckman Coulter Diagnostics (Danaher) 6.14 Becton, Dickinson and Company 6.15 Berkley Lights 6.16 BGI Genomics Co. Ltd 6.17 BillionToOne 6.18 Bioarray Genetics 6.19 Biocartis 6.20 Biocept, Inc. 6.21 Biodesix Inc. 6.22 BioFluidica 6.23 Biolidics Ltd 6.24 bioMerieux Diagnostics 6.25 Bioneer Corporation 6.26 Bio-Rad Laboratories, Inc 6.27 Bio-Techne 6.28 Bioview 6.29 Burning Rock 6.30 Cardiff Oncology 6.31 CareDx 6.32 Caris Molecular Diagnostics 6.33 CellCarta 6.34 CellMax Life 6.35 Cepheid (Danaher) 6.36 Circulogene 6.37 Cizzle Biotech 6.38 Clearbridge Biomedics 6.39 Clinical Genomics 6.40 Cytolumina Technologies Corp. 6.41 Datar Cancer Genetics Limited 6.42 Diagnologix LLC 6.43 Dxcover 6.44 Element Biosciences 6.45 Enzo Biochem 6.46 Epic Sciences 6.47 Epigenomics AG 6.48 Eurofins Scientific 6.49 Exact Sciences 6.50 Fluxion Biosciences (Cell Microsystems) 6.51 Freenome 6.52 Fyr Diagnostics 6.53 GeneFirst Ltd. 6.54 Genetron Holdings 6.55 GILUPI Nanomedizin 6.56 Guardant Health 6.57 HansaBiomed 6.58 Haystack Oncology (Quest Dx) 6.59 iCellate 6.60 ICON PLC 6.61 Illumina 6.62 Incell Dx 6.63 Inivata 6.64 INOVIQ 6.65 Invitae Corporation 6.66 J&J Innovative Medicine 6.67 Lucence Health 6.68 Lunglife AI Inc 6.69 MDNA Life SCIENCES, Inc. 6.70 MDx Health 6.71 Menarini Silicon Biosystems 6.72 Mesa Laboratories, Inc. 6.73 Millipore Sigma 6.74 Miltenyi Biotec 6.75 miR Scientific 6.76 Myriad Genetics 6.77 Nanostring 6.78 NantHealth, Inc. 6.79 Natera 6.80 NeoGenomics 6.81 Novogene 6.82 On-Chip Biotechnologies 6.83 Oncocyte 6.84 OncoDNA 6.85 Oncimmune 6.86 Oxford Nanopore Technologies 6.87 PamGene 6.88 Panagene 6.89 Personalis 6.90 PGDx (Labcorp) 6.91 PrecisionMed 6.92 Predicine 6.93 Predictive Oncology 6.94 Prenetics 6.95 Promega 6.96 Qiagen 6.97 Rarecells SAS 6.98 RareCyte 6.99 Revvity 6.100 Roche Diagnostics 6.101 Saga Diagnostics 6.102 Screencell 6.103 Siemens Healthineers 6.104 simfo GmbH 6.105 Singlera Genomics Inc. 6.106 Singular Genomics 6.107 Standard BioTools 6.108 Stilla Technologies 6.109 Superfluid Dx 6.110 Sysmex Inostics 6.111 Tempus Labs, Inc. 6.112 Thermo Fisher Scientific 6.113 Todos Medical 6.114 Ultima Genomics 6.115 Veracyte 6.116 VolitionRX 6.117 Vortex Biosciences 7 The Global Market for Liquid Biopsy Diagnostics 7.1 Global Market Overview by Country 7.2 Global Market by Cancer - Overview 7.3 Global Market by Usage - Overview 7.4 Global Market by Place - Overview 7.5 Global Market by Marker - Overview 7.6 Global Market by Product - Overview 8 Global Liquid Biopsy Diagnostic Markets - By Cancer 8.1 Breast 8.2 Colorectal 8.3 Cervical 8.4 Lung 8.5 Prostate 9 Global Liquid Biopsy Diagnostic Markets - by Usage 9.1 Screening 9.3 Diagnostic 9.4 Therapy 9.5 Monitor 10 Global Liquid Biopsy Diagnostic Markets - by Place 10.1 Hospital Lab 10.2 Lab Service 10.3 Lab Outpatient 11 Global Liquid Biopsy Diagnostic Markets - by Marker 11.1 Circulating Tumor Cell 11.2 Cell Free DNA 11.3 Vesicle 12 Global Liquid Biopsy Diagnostic Markets - by Product 12.1 Kits 12.2 Instruments 12.3 Service 13 Appendices 13.1 Growth of Approved IVD Test Menu 13.2 Growth of Approved Average IVD Test Fee 13.3 The Most Used IVD Assays 13.4 The Highest Grossing Assays 13.5 Laboratory Fees Schedule For more information about this report visit https://www.researchandmarkets.com/r/e9nbqb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

并购

2024-11-27

·循因缉药

Cologuard 2.0：我们的医保很有钱呀

环球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好。 2024年11月26日，肠癌早筛的扛把子Exact Sciences股价表现活跃，截至收盘上涨9%。据悉，周一刚刚结束的CMS（Centers for Medicare and Medicaid Services） 2025临床实验是费用计划已经确定。本次给于Cologuard Plus，也就是第二代Cologuard 肠癌早筛的报销价格是592美元。 Exact Sciences当初希望得到的方案是635美元，或者是1.25倍Cologuard 1.0的价格（508美元）。这价格是根据这个公式来的： Cologuard Plus = Septin9（192美元）*3+FIT检测（15美元）你甭管为啥是这么算，只要比原来的价格高就行呗。美国医保还是有钱啊。不过，在翻CMS的这份清单的时候，发现了一个好玩的事情。 GeneoScopy的Colosense纳入报销，定价参考原来的Cologuard定价，也就是509美元。更为神奇的是 Singlera Genomic 的ColonAiQ也被纳入了报销，参考Septin 9检测价格，也就是192美元。 Singlera Genomic是谁？他有一个我们更为熟悉的名字：鹍远生物。 ColonAiQ在国内的名字是：常艾克，2024年5月14日中国获批。目前，ColonAiQ并未在美国获得IVD证，应该以LDT形式运行。当然，这里面的价格都是根据有限的信息推断出来的，美国医保里面的报销价格实在是看的眼花缭乱，具体如何去算欢迎评论区大佬指正。另外，据悉Exact Sciences还在跟商保谈判，争取更高的报销价格。话说，商保要不要看看ColonAiQ，让资本主义感受下我们的正义铁拳。最后，我好像忘了跟大家说，Exact Sciences的Cologuard 3.0已经是进行时了。呃，本来应该Q1的时候跟大家汇报，写着写着忘了... END 啊对对对对，扫描这货能联系到我至此，各位股东星标了么？点赞了么？转发了么？在看了么？谢谢！所有内容均不作为投资建议，信息均来自公开资料。 PS：《黑金》那张图我觉得可以一直用... 近期文章： Guardant Health等来的正义：2.925亿美元蛋白测序明星裁员23% 安捷伦Agilent事业群重磅重组！ Twist：拜托了，总统先生药明康德2024Q3：离不开美国，美国也离不开相关资料：注1：https://www.genomeweb.com/reimbursement-news/exact-sciences-shares-rise-unexpected-reimbursement-rate-cms-next-gen-cologuard注2：https://finance.yahoo.com/news/why-exact-sciences-stock-trading-172115662.html

2024-10-16

·GlobeNewswire-Health Care

Singlera Genomics presents results of PDACatch preclinical study at HM Hospitals Annual Early Detection Meeting

SAN DIEGO, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Singlera Genomics, a company focused on the application of novel DNA methylation technologies to genetic diagnosis, presented the results of its initial preclinical study of the PDACatch test, an assay to detect pancreatic cancer in individuals at high risk for the disease, at the HM Hospitals annual Hyper-early Diagnosis in Oncology and its Clinical Management meeting. Pancreatic adenocarcinoma (PDAC) is one of the most deadly forms of cancer, in part due to the majority of diagnoses being late-stage; the five-year survival rate for PDAC is less than 10%. The PDACatch assay is based on Singlera's mTitan platform, which utilizes proprietary library construction and methylation haplotyping to achieve unparalleled conversion rates and cancer detection sensitivity. This technology was previously demonstrated to allow early detection of five types of cancer four years prior to conventional diagnosis (Nature Communications). As part of the preclinical study, Singlera demonstrated that the PDACatch assay could non-invasively retrospectively identify early stage pancreatic cancer in a background population of high-risk patients at high sensitivity. "We were excited to present at the HM Hospitals meeting and show some of our preclinical data for the PDACatch assay. We hope that the PDACatch assay can help with monitoring of patients at high-risk for pancreatic cancer and improve these individuals' quality of life," said Qiang Liu, COO of Singlera Genomics. Singlera Genomics is in the process of launching a clinical trial to obtain FDA pre-market approval for the PDACatch assay in the US, as well as obtaining EU certification for the assay. Singlera Genomics Inc. (www.singlera.com) Singlera Genomics Inc., a globally operating enterprise specializing in non-invasive genetic diagnosis, was established in July 2014. With a presence spanning across continents, the company boasts research and development centers along with business operations worldwide. Singlera is at the forefront of innovation with its proprietary technologies in single-cell sequencing, DNA methylation, and bioinformatics, making significant strides in the global field of genomics. Media ContactAlan Fung, Singlera Genomics858.732.0061alan.fung@singleragenomics.com

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100 项与江苏鹍远生物科技股份有限公司相关的转化医学

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