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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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.

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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.

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At AACR 2025, Geneseeq will showcase seventeen posters from both internal research and collaborative efforts, spanning minimal residual disease (MRD), cancer genomics, biomarker identification, and treatment response—reinforcing our commitment to innovation and excellence across multiple domains, from discovery to clinical impact.

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The following is a summary of our studies that will be presented at ASCO 2024：

Poster 1 (Bd# 276) A multi-center study for colorectal cancer early detection among patients with high-risk disease using a cell-free fragmentomics assay.

Poster 2 (Bd# 34) Leveraging cfDNA fragmentomic features in a stacked ensemble model for early detection of esophageal squamous cell carcinoma.

Poster 3 (Bd# 153) Fragmentomics of cell-free DNA as a sensitive biomarker for early detection of pancreatic cancer.

Poster 4 (Bd# 83) Molecular characterization and biomarker identification in pediatric B-cell acute lymphoblastic leukemia.

Poster 5 (Bd# 460) Genomic profiling of non-small cell lung cancer with rare aberrations in EGFR codon L858 and the survival outcome under real-world first-line EGFR tyrosine kinase inhibitor treatment compared to classic EGFR^L858R

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Geneseeq’s mini-oral presentations will release the most recent results from multi-cancer early detection(MCED) case-control study and the “Jinling cohort,” a 15,000-participant perspective MCED cohort study. In addition to the mini-oral presentations, Geneseeq will present ten posters featuring a diverse range of studies covering various aspects of minimal residual disease (MRD), cancer genomics and biomarker identification.

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Highlights of these studies include:

• A mini oral presentation on discussing the chronic psychological stress in advanced non-small cell lung cancer (NSCLC) treated with first-line immunotherapy
• Data on Geneseeq’s cfDNA fragmentomics model to predict the risk of colorectal cancer
• Two clinical trial studies evaluate the efficacy and safety of new drug combinations in NSCLC and thymic carcinoma

List of abstracts that will be presented at the ESMO 2023 meeting:

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Highlights of these studies include:

• Data on Geneseeq’s new algorithms based on cfDNA fragmentomics features to predict the outcomes of prostate cancer patients as well as to detect lung cancer brain metastases, pulmonary malignancy, and disease progression.
• Two large cohort studies unraveled the landscape of pathogenic/likely pathogenic germline alterations at pan-cancer scale and lung cancer scale.
• Multi-omics analysis of rare cancer populations including fetal adenocarcinoma of the lung and acral melanoma.

List of abstracts that will be presented at the AACR 2023 meeting:

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This study included 128 stage I-III NSCLC patients who received curative surgical resection at the Jiangsu Oncology Hospital. Primary tumor and lymph node metastasis (LNM) samples were collected from surgeries as the standard of care. Plasma samples were collected pre-surgically, 7 days post-surgically, and every three months thereafter. Both tissue and plasma samples were sequenced using the 425-gene Geneseeqprime panel. A total of 645 tissue samples and 628 plasma samples were included in the analyses. The clonal phylogeny of each patient was reconstructed from multi-region tissue sequencing to aid the ctDNA detection.

Interestingly, patients with lung squamous-cell carcinoma displayed more frequent positive ctDNA results than those with lung adenocarcinoma. The detection rates positively correlated with TNM stages and LNM statuses. Smokers were more frequently ctDNA-positive than non-smokers pre-surgically, but not postsurgically. Notably, postsurgical ctDNA monitoring at as early as seven days after surgeries could indicate a high risk of recurrence (HR = 3.90, 95%CI: 1.85-8.20, P = 0.00011), independently of clinicopathological characteristics (multivariate-Cox: HR = 5.49, 95%CI: 1.86-16.20, P = 0.002). ctDNA detection at 3 months and 6 months could also serve as prognostic markers (3 months – HR = 4.32, 95%CI: 2.06-9.08, P < 0.0001; 6 months – HR = 6.19, 95%CI: 2.44-15.69, P < 0.0001). They remained statistically significant after adjusted for clinicopathological characteristics (multivariate-Cox: 3 months – HR = 4.17, 95%CI: 1.80-9.70, P < 0.001; 6 months – HR = 4.59, 95%CI: 1.68-12.50, P < 0.003). Longitudinal ctDNA detection accurately identified patients at high risk of recurrence (univariate-Cox: HR = 7.59, 95%CI: 3.53-16.32, P < 0.0001; multivariate-Cox: HR = 8.33, 95%CI: 3.59 -19.30, P < 0.001) and covered the majority of recurrence cases (73.5%, 25/34). In these cases, ctDNA MRD detection preceded radiographic relapse by a median of 145 days. The time intervals were similar in LUAD (144 days) and LUSC (150 days)

“ctDNA could serve as a promising biomarker for risk of recurrence in NSCLC patients who receive curative surgeries. Longitudinal ctDNA surveillance could reliably predict recurrence, opening a window of ~145 days for timely and optimal disease management”, says Dr. Hua Bao, author and director of Geneseeq Research Institute.

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