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 a research-driven global leader in precision oncology, pioneering next-generation sequencing (NGS) technologies to transform cancer detection, diagnosis, and treatment. Its portfolio spans 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 in Canada and China, Geneseeq operates CAP- and CLIA-certified laboratories and partners with hospitals, academic institutions, and pharmaceutical companies worldwide 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.

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.

The post Geneseeq Unveils Groundbreaking Blood Test for Early Detection of Pancreatic Cancer appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.