May 28, 2025   SOURCE: PR NewsWire

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 /PRNewswire/ - 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.

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.