3 days ago
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.
