COMPANY:

Geneseeq

"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."

"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."

"Geneseeq Technology Inc., shared today that 12 research studies have been accepted for presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, underscoring the company’s continued innovation in cell-free DNA (cfDNA)–based early detection, diagnosis, and minimal residual disease (MRD) monitoring.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."

"Geneseeq Technology Inc., in collaboration with leading clinical institutions, has developed a cutting-edge blood-based screening test that could transform early detection of pancreatic cancer-potentially saving by identifying the disease at more treatable stages. Published in the Journal of Clinical Oncology (Impact Factor: 50.7), this study represents the most comprehensive assessment to date of using cell-free DNA (cfDNA) fragmentomics and artificial intelligence (AI) for early pancreatic cancer detection." "

"Geneseeq Technology Inc. announced...its partnership with Jiangsu Vcare PharmaTech to develop a companion diagnostic (CDx) kit and advance the product launch of Vcare’s pan-neurotrophic tyrosine receptor kinase (NTRK) inhibitor VC004 in China."

"Geneseeq will participate in the ASCO with five interesting topics covering the identification of novel biomarkers and early detection of diverse cancer types."

"Geneseeq’s mini-oral presentations will release the most recent results from its multi-cancer early detection (MCED) trial, the 'Jinling cohort,' and the associated MCED case-control 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, biomarker identification, and treatment response."

"Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA)...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."

"Geneseeq Technology Inc. is excited to share four collaborated studies at the 2023 European Society for Medical Oncology (ESMO) annual meeting from October.20th-24th at Madrid, Spain...Highlights of these studies include:...Data on Geneseeq’s cfDNA fragmentomics model to predict the risk of colorectal cancer..."

"Geneseeq Technology Inc. announced on Thursday that Geneseeq's Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit (Reversible terminator sequencing method) (NSCLC TMB Kit) has gained approval from the Chinese National Medical Products Administration (NMPA) on October 12, 2023 as a Breakthrough Medical Device....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™)."

"Geneseeq will share three mini-oral presentations and five poster studies at the World Conference on Lung Cancer (WCLC) 2023, which will be held on September 9-12th, 2023 in Singapore. These Geneseeq-collaborated studies cover novel prognostic and predictive biomarkers in lung cancer, molecular characterization of prognosis-related lung cancer subtypes, and multi-omics analysis of lung cancer genomic and transcriptomic features."

"Geneseeq Technology Inc. has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union's CE Mark approval. These approvals signify that GeneseeqPrime™ and GeneseeqPrime™ HRD are suitable for solid tumor genomic profiling, while Hemasalus™ DNA/Hemarna™ RNA is cleared for hematological cancer genomic profiling."