Latest news with #Geneseeq
Cision Canada
3 days ago
- Health
- Cision Canada
Geneseeq's Breakthrough Cancer Detection Blood Test Published in Nature Medicine
Large-Scale Study Confirms CanScan ® Test Accurately Detects Early-Stage Cancers From a Simple Blood Draw TORONTO, May 28, 2025 /CNW/ - Geneseeq is proud to announce the publication of results from its large-scale multi-cancer early detection (MCED) study in Nature Medicine, one of the world's leading peer-reviewed medical journals. The publication presents findings from the DECIPHE-Omnia Study (Detecting Early Cancer by Inspecting ctDNA Features), a landmark effort evaluating CanScan ®, Geneseeq's advanced blood-based test for early cancer detection. Innovation Behind CanScan ® CanScan ® is a non-invasive blood test powered by AI-driven whole-genome sequencing. It analyzes subtle cancer-specific changes in circulating cell-free DNA (cfDNA) using Geneseeq's proprietary MERCURY TM Technology. By integrating fragmentomics, genomic, and epigenomic features, the test identifies whether a cancer signal is present and accurately predicts the tissue of origin (TOO). In 2023, CanScan ® received Breakthrough Device Designation from the U.S. FDA. A New Way to Catch Cancer Early Unlike traditional cancer screening tools that are limited to one type of cancer and often involve invasive procedures, CanScan ® offers a convenient, comprehensive solution: a single blood test that screens for more than a dozen cancers at once. In the study: CanScan ® detected early-stage cancers with high accuracy Identified cases missed by routine physical exams Produced a low false-positive rate, helping reduce unnecessary follow-ups "This study brings us closer to making routine multi-cancer screening a reality," said Dr. Yang Shao, CEO of Geneseeq. "Our vision is a future where a simple blood test can help save lives through earlier diagnosis." The Landmark DECIPHER-Omnia Study The DECIPHER-Omnia Study is a multi-phase clinical research program involving more than 8,000 participants to date across three stages: Test development and training using samples from cancer patients and healthy donors Independent clinical validation in a separate cohort A large-scale ongoing screening study in asymptomatic individuals aged 45–75 (the JINLING cohort) The newly published Nature Medicine paper presents interim findings from over 3,700 participants in the JINLING cohort. Key Interim Results: Specificity: 98.1% Sensitivity: 53.5% across all detected cancers; 62.1% for targeted cancer types Early-stage detection: 93% of confirmed cases were Stage 0, I, or II Positive Predictive Value (PPV): 25% — 10 times higher than standard screening (2.2%) Low false positives: Reduced unnecessary follow-up procedures Detection of missed cancers: CanScan ® identified 53.3% of cancers overlooked by standard screening Looking Ahead The JINLING cohort study has now successfully completed enrollment of its target 15,000 participants and is currently in the follow-up and data analysis phase. The complete dataset, along with ongoing monitoring, is expected to provide deeper insights into the real-world utility of CanScan ® for population-level cancer screening. Geneseeq Technology Inc. is a research-driven global leader in precision oncology, pioneering next-generation sequencing (NGS) technologies to transform cancer detection, diagnosis, and treatment. Its portfolio includes comprehensive genomic profiling for all tumor types, cancer-specific panels, minimal residual disease (MRD) monitoring, and multi-cancer early detection (MCED) solutions. Geneseeq has achieved several key regulatory milestones, including CE-IVD certification for its solid tumor and hematologic cancer panels, CE mark and FDA Breakthrough Device Designation for its MCED test, CanScan ®, and NMPA approval for two NGS-based IVD kits in lung cancer, including tumor mutational burden (TMB) detection. With headquarters in Canada and China, Geneseeq operates CAP- and CLIA-certified laboratories and partners with hospitals, research institutions, and pharmaceutical companies worldwide to advance precision medicine.
Cision Canada
07-05-2025
- Health
- Cision Canada
Geneseeq Unveils Groundbreaking Blood Test for Early Detection of Pancreatic Cancer
TORONTO, May 7, 2025 /CNW/ - Geneseeq Technology Inc., in collaboration with leading clinical institutions, has developed a cutting-edge blood-based screening test that could transform early detection of pancreatic cancer-potentially saving by identifying the disease at more treatable stages. Published in the Journal of Clinical Oncology (Impact Factor: 50.7), this study represents the most comprehensive assessment to date of using cell-free DNA (cfDNA) fragmentomics and artificial intelligence (AI) for early pancreatic cancer detection. Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies, largely because it is rarely caught early and diagnosed too late for curative treatment. The five-year survival rate remains around 12%, and currently tools-such as imaging and CA19-9 blood test-often miss early-stage cases. There is currently no recommended population-wide screening method for PDAC. The new test model from Geneseeq analyzes cfDNA fragmentomics-specific patterns of DNA fragments shed into the bloodstream by cancer cells. By applying advanced machine learning algorithm to shallow whole-genome sequencing data, the test can detect subtle genomic and epigenetic changes associated with early-stage PDAC. Key clinical results: Achieved 93.4% sensitivity and 95.2% specificity in the training cohort Reached 90.91-97.3% sensitivity and 92.8-94.5% specificity in multiple validation cohorts Demonstrated strong performance even in early-state cancers Outperformed CA19-9, especially in individuals with normal bilirubin levels "Our cfDNA fragmentomics model offers a practical, highly accurate, and non-invasive option for detecting pancreatic cancer early," said Dr. Hua Bao, VP of R&D at Geneseeq. "It could support earlier identification of at-risk individuals, allowing timely clinical follow-up and potentially improving outcomes." What makes this approach especially promising is its clinical feasibility. The test uses low-coverage sequencing (as little as 0.5×), making it cost-effective and suitable for broader population screening. The test also showed high stability, even with lower DNA sequencing data, and could be used to monitor high-risk patients or suspicious pancreatic lesions. The researchers also estimated that applying this test at the population level could reduce pancreatic cancer mortality by up to 27%, by catching more cancers at a treatable stage. Further research is underway to refine the model's application in screening programs and to validate its effectiveness in more diverse populations. Clinicians may soon have a powerful new tool to help combat one of the hardest-to-detect cancers. About Geneseeq: Geneseeq Technology Inc. (Geneseeq) is a research-driven leader in precision oncology, utilizing cutting-edge next-generation sequencing (NGS) technologies to advance cancer care. The company provides comprehensive genomic profiling solutions for all tumor types, including pan-cancer and cancer-specific panels, alongside cutting-edge tools for minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED). Geneseeq has reached key regulatory milestones to date, including CE-IVD certification for its solid tumor and hematologic cancer panels, and FDA Breakthrough Device Designation for its MCED test, CanScan®. The company has also received approval from the National Medical Products Administration (NMPA) for GeneseeqPrime™, designed for tumor mutational burden (TMB) detection in lung cancer.
