Large-Scale Study Confirms CanScan® TestAccurately Detects Early-Stage Cancers From a Simple Blood Draw
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 theDECIPHE-OmniaStudy (Detecting Early Cancer by Inspecting ctDNA Features), a landmark effort evaluating CanScan®, Geneseeq's advanced blood-based test for early cancer detection.
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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 MERCURYTM 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
TheDECIPHER-Omnia Studyis 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 asymptomaticindividuals aged 45-75 (the JINLING cohort)
The newly published Nature Medicinepaper 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.
About Geneseeq
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.
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SOURCE Geneseeq Technology Inc.
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