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.

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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.

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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.

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The studies span multiple tumor types—including pancreatic, biliary, renal, gastric, lung, ovarian, and esophageal cancers—and collectively demonstrate the power of Geneseeq’s multi-omics platform, integrating whole-genome sequencing, fragmentomics, and AI-driven modeling for non-invasive cancer detection. In addition, SCENT-2 trial study, which was selected for oral presentation (Abstract #7006), evaluated the combination of sintilimab and chidamide followed by P-GemOx in treatment-naïve ENKTL patients using Geneseeq Hemasalus panel.

All studies were conducted in collaboration with leading cancer centers and reflect Geneseeq’s mission to transform oncology through integrated genomics and AI-powered innovation.

Featured Presentations at ASCO 2025:

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 Showcases Cutting-Edge Liquid Biopsy Research Across Multiple Cancer Types at ASCO 2025 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.

International oncology guidelines, such as those from NCCN, ESMO and CSCO, recommend the use of liquid biopsy as an alternative when tumor tissue samples are inaccessible. Currently, most approved NGS IVD kits on China’s market are designed for tumor tissue testing. Geneseeq’s NGS liquid biopsy kit is capable of identifying mutations in multiple key tumor driver genes in a single test with world-leading detection performance, and provides companion diagnostics for a range of targeted therapies. This kit is expected to fill the gap and marks a pioneering step in China’s precision oncology healthcare.

The kit uses advanced non-invasive liquid biopsy testing technology to accurately identify tumor-driving mutations by analyzing circulating tumor DNA (ctDNA) in the blood, without the need for tumor tissue samples. As a valuable complement to traditional tumor tissue testing, it greatly assists clinicians for timely treatment-decision making and drives personalized precision medicine.

Dr. Xiaonan Wang, CTO of Geneseeq, stated, “This kit is the third NGS IVD product from Geneseeq to enter the NMPA Innovative Medical Device program, following the previous NMPA approvals of the ‘EGFR/ALK/ROS1/BRAF/KRAS/HER2 Mutation Detection Kit‘ and the ‘GeneseeqPrime NGS TMB Testing Kit‘ for tumor tissue testing. From 6 genes to 400+ genes, from tumor tissue to liquid biopsy testing, Geneseeq has always been patient-need driven, continuously exploring the translation of cutting-edge technologies into clinical practice. The successful inclusion of this kit in the Innovative Medical Device program highlighted Geneseeq’s R&D strength and innovation capability in the field of precision medicine. We believe that with the continuous technology innovation and clinical application, more and more patients will benefit from the technological advancements for life quality improvement.”

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VC004 is a highly selective next-generation NTRK inhibitor developed to overcome acquired resistance to first-generation NTRK inhibitors in NTRK fusion-positive cancers. VC004 has shown excellent in vitro and in vivo activities, a manageable safety profile and promising efficacy. Currently, there are no commercially available next-generation NTRK inhibitors in China. The introduction of VC004 is poised to fill this significant gap in the market, offering a novel treatment option for patients.

Dr. Xiaonan Wang, Co-founder and CTO of Geneseeq, stated, “Through this deep strategic collaboration, we aim to accelerate the development and clinical application of innovative drugs in China. Our commitment is to provide patients with more treatment options, leading to greater survival benefits.”

The post Geneseeq partners with Jiangsu Vcare PharmaTech to develop a CDx for NTRK inhibitor in China. 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.

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This NSCLC TMB kit entered the NMPA special examination and approval procedures for Breakthrough Medical Devices in January 2020. With the NMPA approval, this kit is used for in vitro qualitative detection of TMB in FFPE tissue samples from patients with EGFR/ALK-negative non-squamous NSCLC. This is the first next-generation sequencing (NGS)-based TMB test kit approved in China with a large gene panel covering 425 cancer-associated genes (GENESEEQPRIME). TMB is a predictive biomarker for the efficacy of immune checkpoint inhibitor therapy.

Prior to this, Geneseeq already had one NGS-based CDx kit for NSCLC, ESSENCARE (EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit), approved by the NMPA through the Breakthrough Medical Devices pathway. GENESEEQPRIME was also CE-IVD marked by the European Medicines Agency in August 2023 for detecting single nucleotide variants, gene amplifications/deletions, translocations, TMB, and microsatellite instability in patients with solid tumors.

“This approval will significantly benefit the clinical implementation of immunotherapy in China with a standardized TMB assessment assay,” Dr. Yang Shao, founder and CEO of Geneseeq Group, said in a statement.

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