Key Findings

In a real-world cohort of nearly 2,000 people at elevated risk for pancreatic cancer (for example, due to diabetes or obesity) and followed for up to two years, Geneseeq’s cfDNA blood test:

• Detected cancer early: Identified 75% (6 of 8) pancreatic ductal adenocarcinoma (PDAC) cases present at enrollment, including every Stage 0 cases and additional Stage I/II cases.
• Provided a lead time advantage: Signaled cancer up to 10 months earlier (median 7.5 months) than imaging could detect it.
• Showed high accuracy: Achieved 97.9% specificity and a 99.9% negative predictive value, indicating very few false positives.
• Aided cyst risk stratification: Correctly flagged a high-risk precancerous lesion (IPMN) while ruling out a low-risk cyst (SCN).
• Outperformed the standard biomarker: The commonly used blood biomarker, CA19-9, detected only 12.5% (1/8) PDAC cases at enrollment and generated far more false positives.

Why This Matters

Pancreatic cancer is among the deadliest cancers, largely because it is often diagnosed too late for effective treatment. Detecting it earlier can make a life-saving difference.

“Our prospective validation in a real-world elevated-risk population shows how cfDNA blood testing could transform pancreatic cancer screening,” said Dr. Hua Bao, Geneseeq’s VP of R&D. “By identifying disease months before imaging, we could shift diagnoses to much earlier, more treatable stages.”

Earlier this year, Geneseeq also contributed to another cfDNA-based pancreatic cancer early detection study published in the Journal of Clinical Oncology.

About Geneseeq

Geneseeq Technology Inc. is aВ research-driven global leader in precision oncology, pioneering next-generation sequencing (NGS) technologies to transform cancer detection, diagnosis, and treatment. Its portfolio spansВ comprehensive genomic profiling across tumor types, cancer-specific diagnostic panels, minimal residual disease (MRD) monitoring, and multi-cancer early detection (MCED) solutions.

The company’s flagship GeneseeqPrime® tumor profiling assay is now FDA-cleared, CE-IVD marked, and NMPA-approved, ensuring accessibility across major jurisdictions. In addition, four other Geneseeq panels have received CE-IVD marking, and its MCED assay CanScan® has been granted FDA Breakthrough Device Designation.

Headquartered inВ Canada and China, Geneseeq operatesВ CAP- and CLIA-certified laboratoriesВ and partners withВ hospitals, academic institutions, and pharmaceutical companies worldwideВ to advance precision medicine and accelerate biomarker-driven therapeutic development.

The post Geneseeq Validates Cell-free DNA Blood Test for Early Detection of Pancreatic Cancer in a Prospective Study appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.

Toronto, Canada – May 27, 2025 – 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 theВ DECIPHE-Omnia Study (Detecting Early Cancer by Inspecting ctDNA Features), a landmark effort evaluating CanScan^В®, Geneseeq’s advanced blood-based test for early cancer detection.

Innovation Behind CanScan^В®

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^В® offers a convenient, comprehensive solution: a single blood test that screens for more than a dozen cancers at once.

In the study:

• CanScan^В® 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

TheВ DECIPHER-Omnia StudyВ 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 MedicineВ 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^В® 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^В® for population-level cancer screening.

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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^В®, 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.

The post Geneseeq’s Breakthrough Cancer Detection Blood Test Published in Nature Medicine appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.

CE-Marked GENESEEQ multi-cancer minimal residual disease detection (Shielding ULTRA MRD) and GENESEEQ multi-cancer early detection (CanScan MCED) kits introduced earlier this year

The GeneseeqPrime kit utilizes a set of 437 genes linked to solid tumors and the reportable range includes single nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), gene translocations and large genomic rearrangements (LGR), as well as tumor mutational burden (TMB), microsatellite instability (MSI), and DNA mismatch repair (MMR) genes. This test provides clinically relevant data that informs and guides therapeutic decisions. It offers crucial insights into pivotal oncogenic genes and possible mechanisms of drug resistance. Apart from the data provided by GeneseeqPrime, the GeneseeqPrime HRD report also incorporates the homologous recombination deficiency (HRD) status that can be used for recommendations in PARP inhibitor treatments. The Hemasalus DNA/Hemarna RNA investigates genetic variations and translocations in 475 genes at the DNA level, while also identifying translocations in 232 genes at the RNA level. This kit aids with clinical diagnosis and facilitates treatment planning for individuals afflicted by hematological malignancies.

“The CE Mark validation for the GeneseeqPrime, GeneseeqPrime HRD, and Hemasalus DNA/Hemarna RNA kits underscores our dedication’s commitment to high quality testing standards on a global level,” said Dr. Xue Wu, CEO of Geneseeq Canada.  The Geneseeq cancer genetic testing kit encompasses a comprehensive assay kit for sequencing, an automated reporting system, and a seamless end-to-end service that covers assay setup and customer support. These kits will now be accessible to healthcare professionals in Europe, enabling them to formulate treatment plans for individuals affected by cancer.

The post Geneseeq Gains CE Marks for NGS-based Test Kits for Solid Tumors and Hematological Cancer appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.