Toronto, Canada тАУ September 2, 2025 тАУ Geneseeq Technology Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for GENESEEQPRIME^┬о 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^┬о assay interrogates 425 cancer-related genes, detecting multiple classes of genomic alterations – including single nucleotide variants (SNVs), insertions/deletions (indels),┬аand 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┬аhigh sensitivity, specificity, and reproducibility┬аacross variant types, supporting the assayтАЩs intended use in clinical oncology.

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

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

тАЬFDA 510(k) clearance of GENESEEQPRIME^┬о marks a major milestone for Geneseeq and for the broader oncology community,тАЭ said┬аXue Wu, PhD, CEO of Geneseeq Technology Inc.┬атАЬBy 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.тАЭ

About Geneseeq

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

The companyтАЩs flagship┬аGeneseeqPrime^┬о tumor profiling assay┬аis 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┬аCanScan^┬о┬аhas been granted┬аFDA Breakthrough Device Designation.

Headquartered in┬аCanada and China, Geneseeq operates┬аCAP- and CLIA-certified laboratories┬аand partners with┬аhospitals, academic institutions, and pharmaceutical companies worldwide┬аto advance precision medicine and accelerate biomarker-driven therapeutic development.

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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.

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

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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.

тАЬThe CE Mark validation for the GeneseeqPrime, GeneseeqPrime HRD, and Hemasalus DNA/Hemarna RNA kits underscores our dedicationтАЩs commitment to high quality testing standards on a global level,тАЭ said┬аDr. Xue Wu, CEO of Geneseeq Canada. ┬аThe 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.

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GeneseeqтАЩs comprehensive genomic profiling panel, GeneseeqPrime^┬о, analyzes genomic alterations in 425 cancer-related genes and assesses key biomarkers, such as tumor mutation burden (TMB) and microsatellite instability (MSI).┬а This pan-cancer panel screens for actionable clinical next steps to therapy by providing valuable insight into key oncogenic genes and drug resistance mechanisms. In Jan 2020, GeneseeqтАЩs TMB Testing Kit in non-small cell lung cancer (NSCLC) became the first comprehensive NGS panel entered into the Breakthrough Medical Devices Program of Chinese National Medical Products Administration (NMPA).

Geneseeq will conduct all analytical, pre-clinical, clinical and other necessary testing studies using IVD instruments and components supplied by Illumina in order to develop and commercialize the IVD kits. The IVD kits will be made available directly to current and future patients acquiring testing services from Geneseeq, as well as testing centers in hospitals. According to Dr. Xue Wu, CEO and co-founder of Geneseeq Toronto, this collaboration will deliver streamlined workflow and produce accurate testing results rapidly. This will help more cancer patients access critical information to optimize their treatment plans, and benefit from precision medicine.

тАЬWeтАЩre pleased to extend our collaboration with Geneseeq to develop assays based on the newly approved NextSeq 550Dx in China.тАЭ said Li Qing, Vice President & General Manager of Greater China at Illumina. тАЬTogether with partners such as Geneseeq, we are able continuously bring in innovative NGS testing products to patients in China, and ultimately help them by unlocking the power of genome.тАЭ

This is the second time that the two companies joined forces to accelerate clinical availability in precision medicine for cancer patients. In 2018, the two companies collaborated on the NMPA approval of the IVD kit, Essencare┬о(EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit, Reversible terminator sequencing) for NSCLC.

About Geneseeq

Geneseeq is a research-driven company providing cutting-edge NGS technology to accelerate precision cancer care, with headquarters located in Canada and China. We offer both pan-cancer panels analyzing 400+ genes and cancer-type specific gene panels to help match patients to optimal treatments, including targeted therapy and immunotherapy. Our CAP/CLIA/ISO15189-accredited Chinese site is equipped with multiple advanced NGS sequencing platforms and has sequenced 420,000+ clinical samples. For more information, please follow us on Linkedin┬аand┬аTwitter.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Its focus on innovation has established it as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Its products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit┬аwww.illumina.com┬аand connect with Illumina on┬аTwitter,┬аFacebook,┬аLinkedIn,┬аInstagram, and┬аYouTube.

For any further inquiries related to our┬аproduct and services, please contact partnership.toronto@geneseeq.com.

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