Addressing Unmet Clinical Needs: Shedding Light on Rare Mutations
NTRK gene family fusions occur in less than 1% of all solid tumors, but represent one of the most actionable oncogenic alterations across cancer types. Patients harboring these fusions can benefit from TRK inhibitors such as ROZLYTREK®. PanTRKare enables accurate, sensitive detection of NTRK1/2/3 fusions across diverse tumor types, bringing precision medicine to patients who harbor this rare but important type of mutations.

Robust Clinical Validation Across 33 Tumor Types and 2,400+ Cases
The PanTRKare kit was rigorously validated through a large-scale multi-center clinical study involving seven leading hospitals, 33 tumor types and more than 2,400 clinical samples. The assay demonstrated high accuracy, sensitivity, reproducibility and broad applicability across a wide spectrum of solid tumors, having successfully detected more than 200 unique NTRK fusion variants in this study. This comprehensive validation establishes PanTRKare as one of the most clinically robust NTRK CDx test globally, ensuring confidence in both routine oncology and translational research settings.

Empowering Targeted Therapies Through Collaborative CDx Development
Clinical bridging studies with ROZLYTREK® showed high concordance of testing results, as well as comparable objective response rate (ORR) among NTRK fusion–positive patients. This result underscores the test’s clinical utility and its pivotal role in advancing precision medicine for patients with rare genetic alterations.

“With the NMPA approval of PanTRKare, clinicians across China can now access an accurate, reliable tool to identify patients with NTRK gene fusions and connect them to effective targeted therapies. This milestone reflects Geneseeq’s ongoing commitment to advancing precision oncology and improving outcomes for patients through innovation in molecular diagnostics,” said Dr. Yang Shao, CEO of Nanjing Geneseeq Technology Inc.. “Geneseeq will continue to drive innovation across oncology diagnostics through global regulatory collaborations, biopharma partnerships, and patient-centered product development, advancing its mission to make precision medicine accessible to all.”

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 countries and regions. 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 Receives NMPA Approval for PanTRKare™ – China’s First NGS-Based Pan-Solid Tumor Companion Diagnostic Kit for NTRK Gene Fusions appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.

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.

Toronto, Canada – September 2, 2025 – Geneseeq Technology Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for GENESEEQPRIME^® NGS Tumor Profiling Assay, an in vitrodiagnostic (IVD) test kit that uses next-generation sequencing (NGS) of DNA from FFPE tumor tissue to detect tumor gene alterations across a comprehensive multi gene panel in patients with solid malignant neoplasms.

The GENESEEQPRIME^® assay interrogates 425 cancer-related genes, detecting multiple classes of genomic alterations – including single nucleotide variants (SNVs), insertions/deletions (indels), and selected gene amplification and translocations – while also reporting microsatellite instability (MSI) and tumor mutation burden (TMB). Analytical and clinical validation studies conducted across multiple U.S. clinical laboratories demonstrated high sensitivity, specificity, and reproducibility across variant types, supporting the assay’s intended use in clinical oncology.

Delivered as a ready-to-use IVD kit, GENESEEQPRIME^® enables decentralized implementation in oncology laboratories, supporting local adoption while ensuring globally harmonized standards. The assay is paired with GENESIS by GENESEEQ^®, the company’s proprietary bioinformatics pipeline and reporting system validated across multiple CLIA/CAP-accredited laboratories. The whole assay solution provides laboratories with a streamlined workflow and a consistent data analysis and reporting framework.

FDA clearance strengthens Geneseeq’s ability to support multi-regional clinical trials, biomarker-driven drug development, and future companion diagnostic (CDx) strategies by offering a standardized, validated platform that promotes data harmonization and operational efficiency across geographies. This milestone follows prior regulatory achievements, including CE-IVD marking in Europe and NMPA approval in China, further positioning Geneseeq as a global leader in precision oncology.

“FDA 510(k) clearance of GENESEEQPRIME^® marks a major milestone for Geneseeq and for the broader oncology community,” said Xue Wu, PhD, CEO of Geneseeq Technology Inc. “By enabling laboratories to deliver high-quality genomic profiling locally on a standardized, regulatory-cleared platform, we are expanding patient access to precision medicine and supporting innovation in cancer care worldwide.”

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 GeneseeqPrime® Gains FDA 510(k) Clearance 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 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.

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

CanScan utilizes low-depth whole-genome sequencing (WGS) on circulating cell-free DNA (cfDNA) from a single tube of peripheral blood, extracting genetic and fragmentomic features to detect early cancer signals with 99% specificity and predict the tissue of origin (TOO) of cancers to help guide next steps for cancer diagnosis. CanScan exhibits promising potential to address unmet medical needs in clinical diagnosis and treatment, particularly for individuals aged 50 and above with an average risk of cancer. The test outperforms current standard of care (SOC) screening methods in common cancer types, such as prostate, lung and liver cancers. It also detects cancer types currently without effective SOC screening methods, such as esophagus, endometrial, gastric, pancreatic cancers and lymphoma.

Built on Geneseeq’s highly sensitive MERCURY multi-omics technology, the performance of CanScan has been validated in large-scale clinical study series, DECIPHER (Detecting Early Cancer by Inspecting ctDNA Features), in over thirteen cancer types. CanScan is currently under real-world evaluation in the Jinling Cohort (NCT06011694), a large-scale prospective multi-center trial. The ongoing recruitment of 15,000 individuals for the phase I trial within the Jinling Cohort is approaching completion.

“The Jinling Cohort aims to further validate the technical performance of CanScan in the targeted screening population,” Dr.Xue Wu, Geneseeq Toronto’s CEO said in a statement, noting that “we will release more results of the Jinling Cohort in 2024.”

This FDA Breakthrough Device Designation follows the CanScan assay kit’s CE approval in January 2023, marking another significant recognition from an internationally authoritative institution.

The post FDA Grants Breakthrough Device Designation for Geneseeq’s Multi-cancer Early Detection Solution appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.